FDA.reportPublic FDA data

Calmatrol

Manufacturer
Goldman Pharmaceutical Group Inc | Goldman Pharmaceutical Group, Inc.
Effective date
2019-02-19
Label type
OTC ANIMAL DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:40:23

Label at a glance#

ProductCalmatrol
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Storage and handling

Other information store at room temperature 20 - 25 C (66 - 78 F) protect from moisture see end flap for expiration date and lot #

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredient (in each capsule)Purpose
Diphenhydramine HCl 25 mgAntihistamine

SPL UNCLASSIFIED SECTION

Uses

  • for the relief of occasional restlessness, hyperactivity and destructive behavior
  • for the relief of anxiety associated with noise, change of environment, loneliness and stress

WARNINGS SECTION

Warnings

Do not use with any other product containing diphenhydramine

  • ask a veterinarian before use if your dog has any chronic illnesses
  • ask a veterinarian or pharmacist if your dog is on any other medication before use
  • keep out of reach of children in case of overdose contact poison control center immediately
  • stop use and contact veterinarian if symptoms persist for more than 72 hours
  • do not use on dogs under 12 pounds

DOSAGE & ADMINISTRATION SECTION

Directions

  • give one capsule every 8 hours as needed
  • for dogs between 12 to 25 pounds
  • do not give more than 3 doses within any 24 hour period

STORAGE AND HANDLING SECTION

Other information

  • store at room temperature 20 - 25 C (66 - 78 F)
  • protect from moisture
  • see end flap for expiration date and lot #

SPL UNCLASSIFIED SECTION

Inactive Ingredients

D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose and starch

SPL UNCLASSIFIED SECTION

Questions or Comments

800.981.7642
petsotc.com

Distributed by
Goldman Pharmaceutical Group Inc.
Holbrook, NY 11741

Tamper-evident : Do not use if carton is open or blister unit is broken or torn

MADE IN AMERICA

PRINCIPAL DISPLAY PANEL - 25 mg Capsule Blister Pack Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pet
otc™
over the counter

Calmatrol®
(Diphenhydramine HCl, 25mg) Antihistamine

HELPS TO
RELIEVE:
Anxiety
Hyperactivity
Destructive behavior

12 - 25 lbs

10 CAPSULES

MADE IN THE USA

Highly recommended by
veterinarians

NDC 72087-021-10

PRINCIPAL DISPLAY PANEL - 25 mg Capsule Blister Pack Carton
PRINCIPAL DISPLAY PANEL - 25 mg Capsule Blister Pack Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN1
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72087-021-10Calmatrol10 in 1 BLISTER PACKCAPSULE101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72087-021CALMATROL (DIPHENHYDRAMINE) CAPSULE [GOLDMAN PHARMACEUTICAL GROUP INC]11 package rows20190510_c10c0c55-b214-4e73-a3c5-ba1a30e4955f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-2035-24EA - Each0904-20350de835bc-a9d8-4642-84e7-35ab90d9c44112020-08-06
0904-2035-59EA - Each0904-2035f29111b7-30ff-4ae3-bc97-b776cde00d6a12012-07-24

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72087-02172087-021-10
0904-2035

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
BUTYLPARABEN3QPI1U3FV8IACT
GELATIN, UNSPECIFIED2G86QN327LIACT
MAGNESIUM STEARATE70097M6I30IACT
PROPYLPARABENZ8IX2SC1OHIACT
POLYSORBATE 806OZP39ZG8HIACT
STARCH, CORNO8232NY3SJIACT
METHYLPARABENA2I8C7HI9TIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEMajor Pharmaceuticals04e70311-6412-4a20-84e3-f6e26d5f19ab2026-02-20WarningsExact identifier
ndc (product): 0904-2035

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.