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Roxee Meds Catalog

Diphenhydramine

Medication catalog facts with explicit FDA-approval, off-label, source-limited, and safety context.

Both Source review pending Not FDA-approved for animals Rx required Official label facts Owner quick guide first
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Data freshness

Storefront facts
Source review pending
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Roxee is still reviewing source support for this medication profile.

FDA applications
Regulatory match pending
No refresh timestamp yet

Roxee has safety or ingredient evidence for this medication, but a regulatory product/application match is still pending.

Safety reports
Safety data refreshed
May 5, 2026, 10:01 a.m.

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

Source timing details
Source timing details
  • Storefront facts: Source Roxee | Refreshed May 5, 2026, 10:05 AM UTC
    The storefront fact projection used for browse cards and quick facts.
  • openFDA reaction terms: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC

Evidence

Reviewed / Updated / Sources

Reviewed by: Not available

Last reviewed: April 15, 2026

Updated: April 15, 2026, 10:04 AM UTC

Sources:
Image coming soon
Diphenhydramine

Diphenhydramine

Drug type: Generic ingredient • Generic profile • Not FDA-approved for animals

Both Rx required 90% storefront ready

Species: Both

Approval status: Not FDA-approved as an animal drug. No FDA-approved animal-drug application is linked for this record. It may represent extra-label, human-drug, bulk-compounding, export-only, or otherwise unapproved animal-use source data; use only under veterinarian direction.

Medication Snapshot

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

Diphenhydramine

Antihistamine sometimes used for allergies/itching and mild allergic reactions; may cause mild sedation. Species commonly shown: Both.

Generic name
Diphenhydramine
Species
Both
Prescription
Prescription required
Completeness
90%
Validation
Incomplete

Indications / Uses

Antihistamine sometimes used for allergies/itching and mild allergic reactions; may cause mild sedation.

Administration / How To Give

Oral

Storage

Store at room temperature.

Warnings / Contraindications

Use caution with glaucoma, urinary retention, or certain cardiac conditions.

  • Use caution with glaucoma, urinary retention, or certain cardiac conditions.

Side Effects

Sedation, dry mouth, GI upset; occasional paradoxical excitement.

FAQ

Both

Yes. Roxee shows this as prescription-only.

Store at room temperature.

Related Medications

Cyclosporine Same category: Allergies / Itching Lokivetmab Same category: Allergies / Itching Oclacitinib Same category: Allergies / Itching Oclacitinib Maleate Same category: Allergies / Itching Prednisone Same category: Allergies / Itching Meloxicam Same category: Allergies / Itching

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:

Antihistamine sometimes used for allergies/itching and mild allergic reactions; may cause mild sedation.

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:

  • Use caution with glaucoma, urinary retention, or certain cardiac conditions
  • Loss of appetite (1 reports)
  • Hair loss (1 reports)
  • Elevated globulins (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.

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?
Major cautions & emergency warning signs

Side effects to monitor:

  • Use caution with glaucoma, urinary retention, or certain cardiac conditions
  • Loss of appetite
  • Hair loss
  • Elevated globulins

Most reported reactions:

  • Loss of appetite (1 reports)
  • Hair loss (1 reports)
  • Elevated globulins (1 reports)

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

Quick Facts

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

Species: Both
Manufacturer: Manufacturer not confirmed
Identifiers:
NDC Package: 21091-695-01 NDC Package: 43655-002-01 NDC Package: 49427-329-45 NDC Package: 49427-329-57 NDC Package: 49427-330-45 NDC Package: 49427-330-57 NDC Package: 70782-200-08 NDC Package: 70782-201-12 NDC Package: 72087-021-10 NDC Package: 72087-022-20 NDC Package: 80547-116-50 NDC Package: 80547-128-50 NDC Product: 21091 NDC Product: 43655 NDC Product: 49427 NDC Product: 70782 NDC Product: 72087 NDC Product: 80547

Warnings / Contraindications

Use caution with glaucoma, urinary retention, or certain cardiac conditions.

  • High: Use caution with glaucoma, urinary retention, or certain cardiac conditions.
Source metadata:

Adverse Reactions

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

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

Tracked signals
32
Reported cases
32
Serious reports
25
Species represented
2
Grouped by Body System
Digestive (4) · Loss of appetite, Diarrhea, Decreased appetite Skin & allergy (1) · Hair loss Neurologic (1) · Unsteady walking (ataxia) Behavior (3) · Biting -aggression, Behavioral disorder (unspecified), Aggression Other (23) · Elevated globulins, Elevated gamma-glutamyl transferase, Elevated creatinine
Most Reported Reactions
Reaction Body system Cases Species Serious cases
Digestive 1 Dog 1
Skin & allergy 1 Dog 1
Other 1 Cat 1
Other 1 Cat 1
Other 1 Cat 1
Other 1 Cat 1
Other 1 Dog 1
Other 1 Cat 1

Species coverage: Dog (17) Cat (15)

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

Storage & Handling

Store at room temperature.

Documents

Owner handouts and official technical documents open on-page first, with the original source still one click away.

Owner handouts

0
No owner handouts linked yet.

Official label / PI

0
No official label or package insert links yet.

SPL

4

FOI

0
No FOI links yet.

Vetadryl 30 SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Vetadryl 30. Use the source link for the full official labeling record.

Calmatrol SPL

SPL · Structured Product Label

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

Calmatrol SPL

SPL · Structured Product Label

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

Diphenhydramine HCL SPL

SPL · Structured Product Label

Open original
FDA Structured Product Label XML for Diphenhydramine HCL. Use the source link for the full official labeling record.
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
  • Storefront facts: Source Roxee | Refreshed May 5, 2026, 10:05 AM UTC
    The storefront fact projection used for browse cards and quick facts.
  • openFDA reaction terms: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed May 5, 2026, 10:04 AM UTC
Official (FDA)
Identity: Generic ingredient • No FDA branded products linked
No official FDA brand rows linked yet for this ingredient.
Manufacturer mapping: Multiple FDA labelers
Case-reported brands (openFDA): MSK
Catalog species: Both
Safety (openFDA)
Top reactions: Dog 60 • Cat 33 • View
Case summaries: 20 (showing 8) • View
openFDA reports are unverified and do not prove causation.
Diagnosis Codes

Diagnosis-code mappings are not available for this medication yet.

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
  • Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Contraindication, High)
Top reaction signals
Loss of appetite (1) Hair loss (1) Elevated globulins (1) Elevated gamma-glutamyl transferase (1) Elevated creatinine (1) Elevated alanine aminotransferase (1) Ear infection NOS (1) Dry mucous membrane (1)

Identifiers & Packages

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

Identifiers
NDC Package: 21091-695-01 NDC Package: 43655-002-01 NDC Package: 49427-329-45 NDC Package: 49427-329-57 NDC Package: 49427-330-45 NDC Package: 49427-330-57 NDC Package: 70782-200-08 NDC Package: 70782-201-12 NDC Package: 72087-021-10 NDC Package: 72087-022-20 NDC Package: 80547-116-50 NDC Package: 80547-128-50 NDC Product: 21091 NDC Product: 43655 NDC Product: 49427 NDC Product: 70782 NDC Product: 72087 NDC Product: 80547
Package NDC Product NDC Form / Route Status
21091-695-01 21091 -
43655-002-01 43655 -
49427-329-45 49427 -
49427-329-57 49427 -
49427-330-45 49427 -
49427-330-57 49427 -
70782-200-08 70782 -
70782-201-12 70782 -
72087-021-10 72087 -
72087-022-20 72087 -
80547-116-50 80547 -
80547-128-50 80547 -

Enriched Documents

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

  • Vetadryl 30 SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Calmatrol SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Calmatrol SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.
  • Diphenhydramine HCL SPL • Structured Product Label • Official
    FDA Structured Product Label from the electronic animal drug product listing directory.

Data Sources & Change Log

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

Official 25 Clinical 60 Manufacturer 0 Marketing 0
Current Field Facts
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-05-05)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-05-03)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-04-30)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-04-29)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-04-28)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-04-27)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-04-26)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-04-25)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-04-17)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-04-15)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-04-15)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-04-11)
  • contraindications: Use caution with glaucoma, urinary retention, or certain cardiac conditions. (Clinical, 2026-02-12)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-21)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-20)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-19)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-17)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-16)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-16)
  • monitoring: Monitor blood glucose and ketones, hydration status, appetite, and clinical response at regular intervals. (Clinical, 2026-04-15)
Recent Revisions
  • side_effects updated 2026-05-05 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-05-05 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-05-05 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-05-03 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-05-03 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-05-03 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-30 10:09 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-30 10:09 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-30 10:09 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-29 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-29 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-29 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-28 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-28 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-28 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-27 10:05 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-27 10:05 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-04-27 10:05 by etl_backfill • Backfilled from existing medication fields
  • side_effects updated 2026-04-26 10:06 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-04-26 10:06 by etl_backfill • Backfilled from existing medication fields

Usage

Antihistamine sometimes used for allergies/itching and mild allergic reactions; may cause mild sedation.

Contraindications

Use caution with glaucoma, urinary retention, or certain cardiac conditions.

Side Effects

Sedation, dry mouth, GI upset; occasional paradoxical excitement.

Source: FDA openFDA • Reference

Top Reported Reactions (openFDA)

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

Digestive
Loss of appetite (1) • Dog Diarrhea (1) • Dog Decreased appetite (1) • Cat Blood in vomit (1) • Cat

Showing top 5 for Digestive.

Skin & allergy
Hair loss (1) • Dog

Showing top 5 for Skin & allergy.

Neurologic
Unsteady walking (1) • Cat

Showing top 5 for Neurologic.

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

Showing top 5 for Behavior.

Other
Elevated globulins (1) • Cat Elevated gamma-glutamyl transferase (1) • Cat Elevated creatinine (1) • Cat Elevated alanine aminotransferase (1) • Cat Ear infection NOS (1) • Dog
Show more (18)
Dullness (1) • Cat Dry mucous membrane (1) • Cat Discomfort NOS (1) • Cat Dilated pupils (1) • Cat Decreased haematocrit (1) • Dog Death (1) • Dog Cyanosis (1) • Dog Crust (1) • Dog Circulatory collapse (1) • Dog Bumps on skin (1) • Dog Breathing difficulty (1) • Dog Blood loss NOS (1) • Dog Aspiration pneumonia (1) • Cat Application site scar (1) • Dog Anaphylaxis (1) • Dog Abnormal radiograph finding (1) • Dog Abnormal histology NOS (1) • Cat Abnormal cytology (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.

Cat, Domestic Shorthair, Male, 7 year, 8.618 kilogram • Drug: MSK, Unassigned, Oral, Frequency: 12 per hour • Reactions: Injection site hair loss, Reddening of the skin, Weight loss, Skin lesion NOS, Wound… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-075379
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 7.00 Year
  • Weight: 8.618 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Unassigned
  • Frequency: 12 per hour
Reactions Reported:
Injection site hair loss Reddening of the skin Weight loss Skin lesion NOS Wound Abnormal cytology Discomfort NOS Skin necrosis Itching Facial swelling (possible allergy) Facial rash
Outcomes: Ongoing

Dog, ['Great Pyrenees', 'Retriever - Labrador'], Female, 31.661 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Vomiting • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-075148
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Weight: 31.661 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
Reactions Reported:
Vomiting
Outcomes: Ongoing

Dog, ['Terrier - Jack Russell', 'Terrier - Bull - American Pit'], Female, 1 year, 17.236 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Vomiting, Hives, Reddening of the skin, Skin irritation, Urine leakage… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-074361
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 1.00 Year
  • Weight: 17.236 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
Reactions Reported:
Vomiting Hives Reddening of the skin Skin irritation Urine leakage Hypersensitivity reaction
Outcomes: Ongoing

Dog, ['Retriever - Golden', 'Poodle - Standard'], Male, 7 year, 43.273 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Thrombocytopenia, Blood loss NOS, Skin petechiae, Death • Outcome: Died

  • Report ID: USA-USFDACVM-2025-US-074431
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 7.00 Year
  • Weight: 43.273 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
Reactions Reported:
Thrombocytopenia Blood loss NOS Skin petechiae Death
Outcomes: Died

Dog, Terrier - Bull - American Pit, Male, 1 year, 33.339 kilogram • Drug: MSK, Tablet, Oral, Dose: 75 Milligram per animal • Reactions: Aggression • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2025-US-074416
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 1.00 Year
  • Weight: 33.339 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
  • Dose: 75 Milligram per animal
Reactions Reported:
Aggression
Outcomes: Recovered/Normal

Dog, Terrier - Boston, Male, 9.75 year, 17.83 kilogram • Drug: MSK, Unassigned, Oral • Reactions: Proteinuria, Hypoalbuminaemia • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-074249
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 9.75 Year
  • Weight: 17.830 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Unassigned
Reactions Reported:
Proteinuria Hypoalbuminaemia
Outcomes: Ongoing

Dog, ['Bichon Frise', 'Chihuahua'], Female, 15 year, 3.493 kilogram • Drug: MSK, Unassigned, Unknown, Frequency: 12 per hour • Reactions: Seizure NOS, Unsteady walking (ataxia), Urinary incontinence • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-074064
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 15.00 Year
  • Weight: 3.493 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
  • Frequency: 12 per hour
Reactions Reported:
Seizure NOS Unsteady walking (ataxia) Urinary incontinence
Outcomes: Ongoing

Dog, Shih Tzu, Female, 11.68 year, 6.53 kilogram • Drug: MSK, Parenteral • Reactions: Not eating, Periorbital oedema, Fever, Local swelling, Nasal discharge… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-074693
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 11.68 Year
  • Weight: 6.530 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Parenteral
Reactions Reported:
Not eating Periorbital oedema Fever Local swelling Nasal discharge Stridor Face and neck swelling Sneezing Respiratory tract disorder NOS Biting -aggression
Outcomes: Ongoing

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

Overdose Information

Overdose causes extreme drowsiness, tremors, seizures, or hyperexcitability. In severe cases, respiratory failure is possible. Treat with IV fluids, seizure control.

Storage & Handling

Store at room temperature.

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