FDA.reportPublic FDA data

Diphenhydramine HCl

Manufacturer
INVAHEALTH INC
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
monthly-update
Hydrated at
2026-06-03 17:51:51

Label at a glance#

ProductDiphenhydramine HCl
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 mg

OTC - PURPOSE SECTION

Antihistamine

OTC - WHEN USING SECTION

Do not use • to make a child sleepy • with any other product containing diphenhydramine, even one used on skin

OTC - ASK DOCTOR SECTION

a breathing problem such as emphysema or chronic bronchitis • glaucoma • trouble urinating due to an enlarged prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

OTC - QUESTIONS SECTION

609-642-6380

INACTIVE INGREDIENT SECTION

Colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, D&C Red No. 3, magnesium stearate, microcrystalline cellulose, polyethylene glycol, hydroxy propyl methyl cellulose talc, titanium dioxide

DOSAGE & ADMINISTRATION SECTION

take every 4 to 6 hours do not take more than 6 doses in 24 hours

adults & children 12 years & over 1 to 2 tablets
children 6 to under 12 years 1 tablet
children under 6 years do not use this product in children under 6 years of age

WARNINGS SECTION

Do not use

to make a child sleepy
with any other product containing diphenhydramine, even one used on skin

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
runny nose
sneezing
itchy, watery eyes
itching of the nose or throat
temporarily relieves these symptoms due to the common cold:
runny nose
sneezing

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Main labelMain label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN3
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD3

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130073376003807GTIN-13: 0073376003807
EAN-13: 0073376003807
GTIN-12: 073376003807
UPC-A: 073376003807
GTIN storage (14 digits): 00073376003807		Diphenhydramine-2022-07-26-for JPEG.jpg

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
73376-003-80Diphenhydramine HCl1000 mg in 1 BOTTLETABLET, FILM COATED10003

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73376-00373376-003-80

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C RED NO. 3PN2ZH5LOQYIACT
TALC7SEV7J4R1UIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEL11K75P92JIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22024-01-08full-release2026-06-01 00:06:56

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 HClDIPHENHYDRAMINE HCLINVAHEALTH INCe4e4004f-77e3-569d-e053-2a95a90a73fe2026-01-08WarningsExact identifier
ndc (package): 73376-003-80
ndc (product): 73376-003
ndc11 (package): 73376000380
spl id: 47e64690-d754-1ea9-e063-6394a90a1499
spl set id: e4e4004f-77e3-569d-e053-2a95a90a73fe

Reported adverse events (FAERS/openFDA)#

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