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Roxee Medication Guide

Imidacloprid

Medication reference facts with explicit FDA-approval, off-label, source-limited, and safety context. Roxee does not sell, prescribe, or dispense medications.

Both Reference complete FDA data linked Non-Rx Chewable Tablets Multiple FDA labelers Official label facts Owner quick guide first
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Data freshness

Reference facts
Reference refreshed
Jun 22, 2026, 10:41 a.m.

These are the reference facts Roxee uses on browse cards and quick facts.

FDA applications
FDA application data refreshed
Jun 22, 2026, 10:41 a.m.

Sponsor, product, and application records imported from Animal Drugs @ FDA.

Safety reports
Safety data refreshed
Jun 22, 2026, 10:42 a.m.

openFDA reaction terms and case summaries are supporting evidence, not proof of causality.

Source timing details
Source timing details
  • Reference facts: Source Roxee | Refreshed Jun 22, 2026, 10:41 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Jun 22, 2026, 10:40 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Jun 22, 2026, 10:41 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
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Imidacloprid

Imidacloprid

Drug type: Generic ingredient • Branded profile • FDA branded products available

Both Chewable Tablets Non-Rx 100% reference complete

Species: Both

Manufacturer: Multiple FDA labelers

Medication Snapshot

Merged from the current Roxee medication system with field-level provenance, freshness, and completeness tracking.

Imidacloprid

For the prevention of heartworm disease caused by Dirofilaria immitis ; kills adult fleas and is indicated for the treatment of flea infestations ( Ctenocephalides felis ). For the prevention of heartworm disease caused by Dirofilaria immitis ; and the treatment of Dirofilaria immitis circulating microfilariae in heartworm-positive dogs; and the treatment and control of intestinal roundworms ( Toxocara canis and Toxascaris leonina ), hookworms ( Ancylostoma caninum and Uncinaria stenocephala ), and whipworms ( Trichuris vulpis ); kills adult fleas and treats flea infestations ( Ctenocephalides felis ); treats and controls sarcoptic mange caused by Sarcoptes scabiei var. canis . For the prevention of heartworm disease in ferrets caused by Dirofilaria immitis ; kills adult fleas ( Ctenocephalides felis ) and is indicated for the treatment of flea infestations on ferrets. Species commonly shown: Both, Dog.

Generic name
Imidacloprid
Brand names
advantus™, Imidacloprid, Advantus
Manufacturer
Multiple FDA labelers
Species
Both, Dog
Dosage forms
Chewable Tablets
Prescription
Non-prescription
Completeness
100%
Validation
Complete
Brand names
advantus™ Imidacloprid Advantus
Dosage forms
Chewable Tablets

Indications / Uses

For the prevention of heartworm disease caused by Dirofilaria immitis ; kills adult fleas and is indicated for the treatment of flea infestations ( Ctenocephalides felis ). For the prevention of heartworm disease caused by Dirofilaria immitis ; and the treatment of Dirofilaria immitis circulating microfilariae in heartworm-positive dogs; and the treatment and control of intestinal roundworms ( Toxocara canis and Toxascaris leonina ), hookworms ( Ancylostoma caninum and Uncinaria stenocephala ), and whipworms ( Trichuris vulpis ); kills adult fleas and treats flea infestations ( Ctenocephalides felis ); treats and controls sarcoptic mange caused by Sarcoptes scabiei var. canis . For the prevention of heartworm disease in ferrets caused by Dirofilaria immitis ; kills adult fleas ( Ctenocephalides felis ) and is indicated for the treatment of flea infestations on ferrets.

Warnings / Contraindications

Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not administer this product orally. For the first 30 minutes after application ensure that dogs cannot lick the product from application sites on themselves or other treated animals. Federal Law restricts this drug to use by or on the order of a licensed veterinarian. Do not use this product (containing 2.5 %moxidectin) on cats. Use only the 0.4 mL ADVANTAGE MULTI for Cats in ferrets. The 0.23 mL size does not provide an effective dose and the 0.8mL size could result in an overdose. Federal (U.S.A.) Law restricts this drug to use by or on the order of a licensed veterinarian. Do not use on sick or debilitated ferrets. Do not apply to irritated skin.

  • Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not administer this product orally. For the first 30 minutes after application ensure that dogs cannot lick the product from application sites on themselves or other treated animals. Federal Law restricts this drug to use by or on the order of a licensed veterinarian. Do not use this product (containing 2.5 %moxidectin) on cats. Use only the 0.4 mL ADVANTAGE MULTI for Cats in ferrets. The 0.23 mL size does not provide an effective dose and the 0.8mL size could result in an overdose. Federal (U.S.A.) Law restricts this drug to use by or on the order of a licensed veterinarian. Do not use on sick or debilitated ferrets. Do not apply to irritated skin.

Side Effects

Top reported reactions (openFDA): Lack of efficacy (ectoparasite) - flea, Pruritus, Lethargy (see also Central nervous system depression in 'Neurological'), Lack of efficacy (endoparasite) - heartworm, Diarrhoea, Behavioural disorder NOS.

FAQ

Both, Dog

No. Roxee does not currently show this as prescription-only.

Chewable Tablets

Related Medications

Afoxolaner Same category: Flea & Tick Doxycycline Same category: Flea & Tick Fluralaner 13.64% 12-Week Chew Same category: Flea & Tick Fluralaner Chew Tablets Same category: Flea & Tick Fluralaner Spot-On Solution Same category: Flea & Tick Lotilaner Same category: Flea & Tick

Related Conditions

Fleas (Flea Infestation) Heartworm Disease Mange (sarcoptic mange, demodicosis) Sarcoptic Mange (Scabies)

Source Transparency

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Pet Owner Quick Guide

Start here first for the safest next-step summary before the deeper medication detail.

Used for:

advantus™ kills adult fleas and is indicated for the treatment of flea infestations on dogs and puppies 10 weeks of age and older and weighing 4 pounds or greater.

Dosing note:

Exact dosing depends on your pet's species, weight, and health status. Use your veterinarian's instructions for the exact dose and schedule.

What to watch for:

  • Do not administer this product orally
  • For the first 30 minutes after application ensure that dogs cannot lick the product from application sites on themselves or other treated animals
  • Do not use this product (containing 2.5 %moxidectin) on cats
  • Use only the 0.4 mL ADVANTAGE MULTI for Cats in ferrets
  • The 0.23 mL size does not provide an effective dose and the 0.8mL size could result in an overdose
  • Federal (U.S.A.) Law restricts this drug to use by or on the order of a licensed veterinarian
  • Do not use on sick or debilitated ferrets
  • Do not apply to irritated skin
  • Diabetes (1 reports)
  • Death (1 reports)
  • Blindness (1 reports)

When to call the vet:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Trouble breathing.
  • Facial swelling or hives.
  • Blood in vomit or stool.

Regulatory restrictions are shown in Vet View.

What to tell or ask your vet today:

  • Is this medicine the right fit for my pet’s current symptoms?
  • Which warning signs mean I should call back right away?
  • How should I handle missed doses or refusal to take the medicine?

Next actions

Talk to a Vet / Find a Vet Near You Save to pet meds Share page Review report evidence
Research brief

Medication Research Insights

A source-aware map of what to know, what is uncertain, and what to verify with your veterinarian.

Source Backed Signals

What to know

Evidence-backed context Limited

Roxee has limited cited overview evidence for Imidacloprid; use the official documents and your veterinarian's instructions for product-specific decisions.

Source: openFDA case USA-USFDACVM-2025-US-073618
Safety signal coverage Reported signals

32 tracked reaction signals; 32 reported cases; 3 serious reports; 2 species groups. These are reporting and label-derived signals for interpretation with a veterinarian.

Source: openFDA case USA-USFDACVM-2025-US-073618
Interpretation guardrail Not causation

Adverse-event reports help form a watch list, but they do not prove the medication caused the reaction and they are not a risk ranking between medications.

Evidence tension

Stronger signal Label / review

Official labels, package inserts, and reviewed summaries carry more weight than isolated reports.

Source: openFDA case USA-USFDACVM-2025-US-073618
Weaker signal Reported data

Case reports and openFDA terms are useful for pattern awareness, but they are incomplete, can include multiple exposures, and do not estimate an individual pet's probability of harm.

Reaction signal map

Most reported reactions Top terms

Diabetes (1 reports), Death (1 reports), Blindness (1 reports), Tiredness (lethargy) (1 reports), Reddening of the skin (1 reports)

Body systems represented Signal grouping

Skin & allergy (6), Neurologic (1), Behavior (2), Effectiveness (7)

Explore supporting adverse reports

Species and breed lens

Species represented in reports Species lens

Cat (19 reports), Dog (13 reports)

Breed metadata in reports Metadata only

Chihuahua (1), Shih Tzu (1). These are report metadata, not proof that a breed is at higher risk.

What your vet may verify

Fit for this patient Vet check

Verify whether Imidacloprid fits the pet's species, current diagnosis, age, weight, organ status, pregnancy/lactation status, and concurrent medications.

Evidence limitations Evidence review

Separate label-backed warnings from adverse-event reports and owner observations before changing the plan.

What to watch next

Watch list Owner-safe

Do not administer this product orally, For the first 30 minutes after application ensure that dogs cannot lick the product from application, Do not use this product (containing 2.5 %moxidectin) on cats, Use only the 0.4 mL ADVANTAGE MULTI for Cats in ferrets, The 0.23 mL size does not provide an effective dose and the 0.8mL size could result in an overdose

Call sooner if Escalation

Repeated vomiting or diarrhea. Severe lethargy (hard to wake, very low energy). Collapse or fainting.

Bottom line: Use this Imidacloprid brief as a structured watch list and source map, not as a reason to start, stop, or change treatment without your veterinarian.
Vet source depth
  1. openFDA case USA-USFDACVM-2025-US-073618 · adverse_reaction · adverse reactions
  2. Contraindication source · fda_animal_drugs · warnings contraindications
  3. FDA application profile · official_label · quick facts
  4. Medication usage source · fda_animal_drugs · quick facts
  5. FOI · document · documents
  6. SPL · document · documents
  7. Structured Product Label · document · documents
  8. Structured Product Label · document · documents

Evidence

Review status / Updated / Sources

Review status: Clinical reviewer not listed

Updated: February 12, 2026, 10:44 PM UTC

Sources:
Safety & side effects

Side effects to monitor:

  • Do not administer this product orally
  • For the first 30 minutes after application ensure that dogs cannot lick the product from application sites on themselves or other treated animals
  • Do not use this product (containing 2.5 %moxidectin) on cats
  • Use only the 0.4 mL ADVANTAGE MULTI for Cats in ferrets
  • The 0.23 mL size does not provide an effective dose and the 0.8mL size could result in an overdose

Most reported reactions:

  • Diabetes (1 reports)
  • Death (1 reports)
  • Blindness (1 reports)
Explore reported case details

Emergency warning signs:

  • Repeated vomiting or diarrhea.
  • Severe lethargy (hard to wake, very low energy).
  • Collapse or fainting.
  • Trouble breathing.
Talk to a Vet / Find a Vet Near You Start Symptom Intake

Vet Fast Scan

Source-backed clinical checkpoints for quick review.

FDA-labeled species
Dog
Indication / use
advantus™ kills adult fleas and is indicated for the treatment of flea infestations on dogs and puppies 10 weeks of age and older and weighing 4 pounds or greater.
Form / route / dose
Form: Chewable Tablets
Route: Oral
Confirm product label and patient-specific plan.
Warnings
  • High: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not administer this product or…
Adverse-event caveat
openFDA adverse-event cases are reported signals. They are not verified, do not prove causation, and do not estimate a pet's individual risk.
Source docs

Quick Facts

Official label facts first, then secondary summaries. Marketing content is separated below.

Species: Both
Manufacturer: Multiple FDA labelers
Form: Chewable Tablets
Identifiers:
ANADA: 200615 ANADA: 200638 ANADA: 200700 ANADA: 200701 ANADA: 200714 ANADA: 200716 ANADA: 200718 ANADA: 200721 ANADA: 200811 ANADA: 200818 NADA: 141208 NADA: 141251 NADA: 141254 NADA: 141435 NDC Package: 17030-023-01 NDC Package: 17030-023-03 NDC Package: 17030-025-01 NDC Package: 17030-025-06 NDC Package: 17030-043-01 NDC Package: 17030-043-06
Source metadata:

Warnings / Contraindications

Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not administer this product orally. For the first 30 minutes after application ensure that dogs cannot lick the product from application sites on themselves or other treated animals. Federal Law restricts this drug to use by or on the order of a licensed veterinarian. Do not use this product (containing 2.5 %moxidectin) on cats. Use only the 0.4 mL ADVANTAGE MULTI for Cats in ferrets. The 0.23 mL size does not provide an effective dose and the 0.8mL size could result in an overdose. Federal (U.S.A.) Law restricts this drug to use by or on the order of a licensed veterinarian. Do not use on sick or debilitated ferrets. Do not apply to irritated skin.

  • High: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not administer this product orally. For the first 30 minutes after application ensure that dogs cannot lick the product from application sites on themselves or other treated animals. Federal Law restricts this drug to use by or on the order of a licensed veterinarian. Do not use this product (containing 2.5 %moxidectin) on cats. Use only the 0.4 mL ADVANTAGE MULTI for Cats in ferrets. The 0.23 mL size does not provide an effective dose and the 0.8mL size could result in an overdose. Federal (U.S.A.) Law restricts this drug to use by or on the order of a licensed veterinarian. Do not use on sick or debilitated ferrets. Do not apply to irritated skin.
Source metadata:

Adverse Reactions

Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.

Reported case explorer

Filter stored openFDA reports by pet and report attributes. Counts describe reports in this data set, not risk.

Clear filters
openFDA adverse-event cases are reported signals. They are not verified, do not prove causation, and do not estimate a pet's individual risk.
Stored reports
2
Matching reports
1
Active filters
1
Selected filters
Reaction: Lack of efficacy (ectoparasite) - flea Clear
Reset
Drill into common report signals
Lack of efficacy (ectoparasite) - flea (1) Overdose (1) Vomiting (1) Digestive (1) Effectiveness (1) Other (1)
Showing up to 50 matching reports.

USA-USFDACVM-2025-US-073236

Received 2025-12-11 · MSK · MSK

Non-serious
Species
Dog
Breed
Shih Tzu
Size / weight
10-24 lb (6.804 Kilogram)
Age
1-3 years (2 Year)
Sex
Male Intact
Region
USA
Reactions
Lack of efficacy (ectoparasite) - flea
Body systems
Effectiveness
Outcomes
Outcome Unknown

Tap or hover a reaction to see what it means in plain language.

Tracked signals
32
Reported cases
32
Serious reports
3
Species represented
2
Grouped by Body System
Skin & allergy (6) · Localised itching, Localised hair loss, Hives Neurologic (1) · Tiredness (lethargy) Behavior (2) · Biting -aggression, Behavioral disorder (unspecified) Effectiveness (7) · Lack of efficacy - NOS, Lack of efficacy (protozoa) - Giardia, Lack of efficacy (endoparasite) - hookworm Other (16) · Reddening of the skin, Product label issues, Patient instructions for use on label confusing
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Other 1 Cat 1
Other 1 Cat 1
Other 1 Dog 1
Neurologic 1 Cat 0
Other 1 Dog 0
Other 1 Dog 0
Other 1 Dog 0
Other 1 Dog 0

Species coverage: Cat (19) Dog (13)

View detailed reaction table
Reaction Body system Species Seriousness Frequency Reports
Neurologic Cat Non-serious - 1
Other Dog Non-serious - 1
Other Dog Non-serious - 1
Other Dog Non-serious - 1
Other Dog Non-serious - 1
Other Dog Non-serious - 1
Other Dog Non-serious - 1
Skin & allergy Cat Non-serious - 1
Skin & allergy Cat Non-serious - 1
Other Cat Non-serious - 1
Effectiveness Dog Non-serious - 1
Effectiveness Dog Non-serious - 1
Effectiveness Dog Non-serious - 1
Effectiveness Dog Non-serious - 1
Effectiveness Cat Non-serious - 1
Effectiveness Cat Non-serious - 1
Effectiveness Dog Non-serious - 1
Other Cat Non-serious - 1
Skin & allergy Cat Non-serious - 1
Other Cat Non-serious - 1
Skin & allergy Cat Non-serious - 1
Other Cat Non-serious - 1
Skin & allergy Cat Non-serious - 1
Other Cat Non-serious - 1
Other Cat Serious - 1
Other Cat Serious - 1
Skin & allergy Cat Non-serious - 1
Other Cat Non-serious - 1
Other Dog Serious - 1
Behavior Cat Non-serious - 1
Behavior Dog Non-serious - 1
Other Cat Non-serious - 1
Source metadata:

Source Documents

The most useful source links appear first; full previews and metadata stay in the veterinary/professional layer.

Use original documents to confirm product-specific warnings, ingredients, and handling details with your veterinarian.

advantus™ SPL · SPL Imidacloprid SPL SPL · Structured Product Label Advantus SPL SPL · Structured Product Label

Full source previews and metadata remain in the veterinary/professional layer.

Owner handouts

0
No owner handouts linked yet.

Official label / PI

0
No official label or package insert links yet.

SPL

4

FOI

18

advantus™

SPL · SPL

Open original
FDA Structured Product Label

advantus™

Rendered from Roxee's cached FDA SPL package contents for on-page reading. Use Open original for the raw FDA ZIP/XML source.

Sponsor
Elanco US Inc.
NADA
141-435
Status
OTC
Form
Chewable Tablets
Route
Oral
Species
Dog
Composition / specifications
Each chewable tablet contains either 7.5 mg or 37.5 mg of imidacloprid.

Dogs

Indication
advantus™ kills adult fleas and is indicated for the treatment of flea infestations on dogs and puppies 10 weeks of age and older and weighing 4 pounds or greater.
Dosage
Administer daily one 7.5-mg chew to dogs weighing 4 to 22 pounds or one 37.5-mg chew to dogs weighing 23 to 110 pounds.
Limitations
Do not give to puppies younger than 10 weeks of age or to dogs weighing less than 4 pounds. Do not give more than one tablet a day.

Imidacloprid SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Imidacloprid. Use the source link for the full official labeling record.

Advantus SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Advantus. Use the source link for the full official labeling record.

Advantus SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Advantus. Use the source link for the full official labeling record.

UCM433795.pdf

FOI · FOI

Open original

ANADA 200-700 FOI Summar.pdf

FOI · FOI summary

Open original

FOI Summary oA 200-714 Approved November 24, 2021.pdf

FOI · FOI summary

Open original

FOI Summary oA 200-818 Approved August 5, 2025.pdf

FOI · FOI summary

Open original

FOI Summary oA 200-718 Approved February 7, 2022.pdf

FOI · FOI summary

Open original

FOI Summary oA 200-811 Approved March 24, 2025.pdf

FOI · FOI summary

Open original

FOI Summary oA 200-701 Approved June 10, 2021.pdf

FOI · FOI summary

Open original

FOI Summary sA 200-701 Approved February 9, 2023.pdf

FOI · FOI summary

Open original

FOI Summary oA 200-721 Approved March 28, 2022.pdf

FOI · FOI summary

Open original

FOI Summary sA 200-721 Approved January 12, 2023.pdf

FOI · FOI summary

Open original

FOI Summary oA 200-716 Approved January 28, 2022.pdf

FOI · FOI summary

Open original

UCM051438.pdf

FOI · FOI summary

Open original

UCM381705.pdf

FOI · FOI summary

Open original

UCM051423.pdf

FOI · FOI summary

Open original

UCM381709.pdf

FOI · FOI summary

Open original

FOI Summary oA 200-638 Approved May 27, 2020.pdf

FOI · FOI summary

Open original

FOI Summary oA 200-615 Approved December 19, 2019.pdf

FOI · FOI summary

Open original

ucm117758.pdf

FOI · FOI summary

Open original
Source metadata:
Veterinary reference (advanced)

Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.

At a Glance

Quick facts and links to official labeling and safety signals.

Data freshness
  • Reference facts: Source Roxee | Refreshed Jun 22, 2026, 10:41 AM UTC
    The reference fact projection used for browse cards and quick facts.
  • Animal Drugs @ FDA: Source FDA | Refreshed Jun 22, 2026, 10:40 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Jun 22, 2026, 10:41 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Jun 22, 2026, 10:45 AM UTC
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: Advantus Imidacloprid
Manufacturer mapping: Multiple FDA labelers
Case-reported brands (openFDA): MSK
Catalog species: Both • FDA-labeled species: Dog
Rx/OTC: OTC
Form/route: Chewable Tablets • Oral
Applications: NADA 141-435
NDC: Packages 58198-0017-1 58198-0017-2 58198-0017-3 58198-0018-1 58198-0018-2 58198-0018-3 • Products 58198 86154
Documents: 1 (FOI: 1) • SPL: 1 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 3 • Cat 0 • View
Case summaries: 2 (showing 2) • View
openFDA reports are unverified and do not prove causation.
Explore
Linked using: Fda_Label (0.95), Usage_Inferred (0.78), Usage_Inferred (0.78)
Diagnosis Codes
ICD10_CM: B74.8 ICD10_CM: B82.9 ICD10_CM: B86 ICD10_CM: B88.1
Other filariases

Counseling and Monitoring Highlights

Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.

Owner-facing counseling points
  • Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not administer this product orally. For the first 30 minutes after application ensure that dogs cannot lick the product from application sites on themselves or other treated animals. Federal Law restricts this drug to use by or on the order of a licensed veterinarian. Do not use this product (containing 2.5 %moxidectin) on cats. Use only the 0.4 mL ADVANTAGE MULTI for Cats in ferrets. The 0.23 mL size does not provide an effective dose and the 0.8mL size could result in an overdose. Federal (U.S.A.) Law restricts this drug to use by or on the order of a licensed veterinarian. Do not use on sick or debilitated ferrets. Do not apply to irritated skin. (Contraindication, High)
Top reaction signals
Diabetes (1) Death (1) Blindness (1) Tiredness (lethargy) (1) Reddening of the skin (1) Product label issues (1) Patient instructions for use on label confusing (1) Overdose (1)

Identifiers & Packages

Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.

Identifiers
ANADA: 200615 ANADA: 200638 ANADA: 200700 ANADA: 200701 ANADA: 200714 ANADA: 200716 ANADA: 200718 ANADA: 200721 ANADA: 200811 ANADA: 200818 NADA: 141208 NADA: 141251 NADA: 141254 NADA: 141435 NDC Package: 17030-023-01 NDC Package: 17030-023-03 NDC Package: 17030-025-01 NDC Package: 17030-025-06 NDC Package: 17030-043-01 NDC Package: 17030-043-06 NDC Package: 17030-044-01 NDC Package: 17030-044-06 NDC Package: 17030-080-01 NDC Package: 17030-080-06
Package NDC Product NDC Form / Route Status
17030-023-01 17030 -
17030-023-03 17030 -
17030-025-01 17030 -
17030-025-06 17030 -
17030-043-01 17030 -
17030-043-06 17030 -
17030-044-01 17030 -
17030-044-06 17030 -
17030-080-01 17030 -
17030-080-06 17030 -
17030-103-01 17030 -
17030-103-06 17030 -
17030-400-01 17030 -
17030-400-06 17030 -
17030-500-01 17030 -
17030-500-06 17030 -
51072-100-01 51072 -
51072-100-02 51072 -
51072-100-03 51072 -
51072-100-04 51072 -

Enriched Documents

Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.

Data Sources & Change Log

Every non-trivial field is expected to include provenance and update timestamps.

Official 140 Clinical 1 Manufacturer 0 Marketing 0
Current Field Facts
  • side_effects: Top reported reactions (openFDA): Lack of efficacy (ectoparasite) - flea, Pruritus, Lethargy (see also Central nervous system depression in 'Neurological'), La… (Clinical, 2026-04-11)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not administer this product orally. For the first 30 minutes after app… (Official, 2026-04-12)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not administer this product orally. For the first 30 minutes after app… (Official, 2026-04-11)
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not administer this product orally. For the first 30 minutes after app… (Official, 2026-02-12)
  • indications: Advantus™ kills adult fleas and is indicated for the treatment of flea infestations on dogs and puppies 10 weeks of age and older and weighing 4 pounds or grea… (Official, 2026-06-22)
  • indications: Advantus™ kills adult fleas and is indicated for the treatment of flea infestations on dogs and puppies 10 weeks of age and older and weighing 4 pounds or grea… (Official, 2026-06-22)
  • indications: Advantus™ kills adult fleas and is indicated for the treatment of flea infestations on dogs and puppies 10 weeks of age and older and weighing 4 pounds or grea… (Official, 2026-06-21)
  • indications: Advantus™ kills adult fleas and is indicated for the treatment of flea infestations on dogs and puppies 10 weeks of age and older and weighing 4 pounds or grea… (Official, 2026-06-20)
  • indications: Advantus™ kills adult fleas and is indicated for the treatment of flea infestations on dogs and puppies 10 weeks of age and older and weighing 4 pounds or grea… (Official, 2026-06-13)
  • indications: Advantus™ kills adult fleas and is indicated for the treatment of flea infestations on dogs and puppies 10 weeks of age and older and weighing 4 pounds or grea… (Official, 2026-06-12)
  • indications: Advantus™ kills adult fleas and is indicated for the treatment of flea infestations on dogs and puppies 10 weeks of age and older and weighing 4 pounds or grea… (Official, 2026-06-12)
  • indications: Advantus™ kills adult fleas and is indicated for the treatment of flea infestations on dogs and puppies 10 weeks of age and older and weighing 4 pounds or grea… (Official, 2026-06-11)
  • indications: Advantus™ kills adult fleas and is indicated for the treatment of flea infestations on dogs and puppies 10 weeks of age and older and weighing 4 pounds or grea… (Official, 2026-06-11)
  • indications: Advantus™ kills adult fleas and is indicated for the treatment of flea infestations on dogs and puppies 10 weeks of age and older and weighing 4 pounds or grea… (Official, 2026-06-10)
  • indications: Advantus™ kills adult fleas and is indicated for the treatment of flea infestations on dogs and puppies 10 weeks of age and older and weighing 4 pounds or grea… (Official, 2026-06-09)
  • indications: Advantus™ kills adult fleas and is indicated for the treatment of flea infestations on dogs and puppies 10 weeks of age and older and weighing 4 pounds or grea… (Official, 2026-06-08)
  • indications: Advantus™ kills adult fleas and is indicated for the treatment of flea infestations on dogs and puppies 10 weeks of age and older and weighing 4 pounds or grea… (Official, 2026-06-07)
  • indications: Advantus™ kills adult fleas and is indicated for the treatment of flea infestations on dogs and puppies 10 weeks of age and older and weighing 4 pounds or grea… (Official, 2026-06-06)
  • indications: Advantus™ kills adult fleas and is indicated for the treatment of flea infestations on dogs and puppies 10 weeks of age and older and weighing 4 pounds or grea… (Official, 2026-06-05)
  • indications: Advantus™ kills adult fleas and is indicated for the treatment of flea infestations on dogs and puppies 10 weeks of age and older and weighing 4 pounds or grea… (Official, 2026-06-04)
Recent Revisions
  • side_effects updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-12 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-11 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields

FDA Products & Applications (Animal Drugs @ FDA)

Official sponsor/proprietary-name/application-status records linked by active ingredient.

Product Sponsor Application Status Published
advantus™
OTC
Imidacloprid
Chewable Tablets • Oral
Label highlights
Official documents
Elanco US Inc. NADA 141-435 Approved May 21, 2021

Data source: FDA Animal Drugs @ FDA (public search export).

What It's For (FDA Label Highlights)

Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.

Species: Dog
Composition / specifications
Each chewable tablet contains either 7.5 mg or 37.5 mg of imidacloprid.
Dogs
Indication
advantus™ kills adult fleas and is indicated for the treatment of flea infestations on dogs and puppies 10 weeks of age and older and weighing 4 pounds or greater.
Dosage
Administer daily one 7.5-mg chew to dogs weighing 4 to 22 pounds or one 37.5-mg chew to dogs weighing 23 to 110 pounds.
Limitations
Do not give to puppies younger than 10 weeks of age or to dogs weighing less than 4 pounds. Do not give more than one tablet a day.

FDA page: Open in Animal Drugs @ FDA

Usage

For the prevention of heartworm disease caused by Dirofilaria immitis ; kills adult fleas and is indicated for the treatment of flea infestations ( Ctenocephalides felis ). For the prevention of heartworm disease caused by Dirofilaria immitis ; and the treatment of Dirofilaria immitis circulating microfilariae in heartworm-positive dogs; and the treatment and control of intestinal roundworms ( Toxocara canis and Toxascaris leonina ), hookworms ( Ancylostoma caninum and Uncinaria stenocephala ), and whipworms ( Trichuris vulpis ); kills adult fleas and treats flea infestations ( Ctenocephalides felis ); treats and controls sarcoptic mange caused by Sarcoptes scabiei var. canis . For the prevention of heartworm disease in ferrets caused by Dirofilaria immitis ; kills adult fleas ( Ctenocephalides felis ) and is indicated for the treatment of flea infestations on ferrets.

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not administer this product orally. For the first 30 minutes after application ensure that dogs cannot lick the product from application sites on themselves or other treated animals. Federal Law restricts this drug to use by or on the order of a licensed veterinarian. Do not use this product (containing 2.5 %moxidectin) on cats. Use only the 0.4 mL ADVANTAGE MULTI for Cats in ferrets. The 0.23 mL size does not provide an effective dose and the 0.8mL size could result in an overdose. Federal (U.S.A.) Law restricts this drug to use by or on the order of a licensed veterinarian. Do not use on sick or debilitated ferrets. Do not apply to irritated skin.

Top Reported Reactions (openFDA)

De-duplicated reaction terms grouped by body system from FDA openFDA reports (not verified; does not prove causation).

Skin & allergy
Localised itching (1) • Cat Localised hair loss (1) • Cat Hives (1) • Cat Hair loss NOS (1) • Cat Face and neck swelling (1) • Cat
Show more (1)
Chewing - pruritus (1) • Cat

Showing top 5 for Skin & allergy.

Neurologic
Tiredness (1) • Cat

Showing top 5 for Neurologic.

Behavior
Biting -aggression (1) • Cat Behavioral disorder (1) • Dog

Showing top 5 for Behavior.

Effectiveness
Lack of efficacy - NOS (1) • Dog Lack of efficacy (protozoa) - Giardia (1) • Dog Lack of efficacy (endoparasite) - hookworm (1) • Dog Lack of efficacy (endoparasite) - heartworm (1) • Dog Lack of efficacy (ectoparasite) - flea (1) • Cat
Show more (2)
Lack of efficacy (ectoparasite) - ear mite (1) • Cat Lack of efficacy (bacteria) - Borrelia (1) • Dog

Showing top 5 for Effectiveness.

Other
Reddening of the skin (1) • Dog Product label issues (1) • Dog Patient instructions for use on label confusing (1) • Dog Overdose (1) • Dog Medication error NOS (1) • Dog
Show more (11)
Loose stool (1) • Dog Licking at application site (1) • Cat Hyperactivity (1) • Cat Hiding (1) • Cat Foaming at the mouth (1) • Cat Expired drug administered (1) • Cat Diabetes (1) • Cat Death (1) • Cat Blistering (1) • Cat Blindness (1) • Dog Abnormal urine odour (1) • Cat

Showing top 5 for Other.

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Adverse Event Case Summaries (openFDA)

These are individual FDA adverse event reports. They are unverified and do not prove the medication caused the reaction.

Dog, Chihuahua, Unknown, 2.268 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 1 Other per animal • Reactions: Vomiting, Overdose • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-075241
  • Serious AE: No
  • Treated For AE: No
  • Sex: Unknown
  • Weight: 2.268 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
  • Dose: 1 Other per animal
Reactions Reported:
Vomiting Overdose
Outcomes: Ongoing

Dog, Shih Tzu, Male, 2 year, 6.804 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 1 tablet per animal • Reactions: Lack of efficacy (ectoparasite) - flea • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-073236
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 2.00 Year
  • Weight: 6.804 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
  • Dose: 1 tablet per animal
Reactions Reported:
Lack of efficacy (ectoparasite) - flea
Outcomes: Outcome Unknown

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Overdose Information

No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.

Storage & Handling

No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.

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