FDA.reportPublic FDA data

Diphenhydramine HYDROCHLORIDE

Manufacturer
HF Acquisition Co LLC, DBA HealthFirst
Effective date
2024-10-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:27:48

Label at a glance#

ProductDiphenhydramine HYDROCHLORIDE
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure14 sections

Indications and uses

 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

Dosage and administration

 take every 4 to 6 hours, or as directed by a doctor  do not take more than 6 doses in 24 hours adults and children 12 years of age and over 1 to 2 capsules children 6 to under 12 years of age 1 capsule children under 6 years of age do not use this product in children under 6 years of age

Label contents#

Full prescribing information#

DRUG FACTS

SPL UNCLASSIFIED SECTION

Active ingredient (in each capsule)
Diphenhydramine HCl 25 mg

OTC - PURPOSE SECTION

Purpose
Antihistamine

USES

SPL UNCLASSIFIED 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

WARNINGS SECTION

 to make a child sleepy

 with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have
 a breathing problem such as emphysema or chronic bronchitis

 glaucoma
 trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers

When using this product

 marked drowsiness may occur

 avoid alcoholic drinks
 alcohol, sedatives and tranquilizers may increase drowsiness

 be careful when driving a motor vehicle or operating machinery

 excitability may occur, especially in children

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

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

DIRECTIONS

SPL UNCLASSIFIED SECTION

 take every 4 to 6 hours, or as directed by a doctor

 do not take more than 6 doses in 24 hours

adults and children
12 years of age and over 1 to 2 capsules
children 6 to
under 12 years of age 1 capsule
children under 6 years of age do not use this product
in children under 6 years of age

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

 store in a dry place at 15° – 30°C (59° – 86°F)

INACTIVE INGREDIENT SECTION

corn starch, D&C red #28, FD&C blue #1, FD&C red #40, gelatin, lactose monohydrate, magnesium stearate, sodium lauryl sulfate

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN. DO NOT USE IF PRODUCT APPEARS TO BE
TAMPERED WITH OR IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING.
DO NOT USE IF RED CAPSULE BAND IS BROKEN OR MISSING.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

QUESTIONS OR COMMENTS

OTC - QUESTIONS SECTION

1-800-616-2471

OTC - WHEN USING SECTION

When using this product

 marked drowsiness may occur

 avoid alcoholic drinks
 alcohol, sedatives and tranquilizers may increase drowsiness

 be careful when driving a motor vehicle or operating machinery

 excitability may occur, especially in children

DOSAGE & ADMINISTRATION SECTION


ORAL


Diphenhydramine HCl 25 mg

take every 4 to 6 hours, or as directed by a doctor

do not take more than 6 doses in 24 hours

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CARTON LABELCARTON LABEL

RFID LabelRFID Label

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
51662-1628-1Diphenhydramine HYDROCHLORIDE2 in 1 CARTONCAPSULE21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1628DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [HF ACQUISITION CO LLC, DBA HEALTHFIRST]1Current NDC, 1 package rows20241023_25034563-6422-daf6-e063-6394a90af980.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7237-24EA - Each0904-72370f407112-e93a-4544-a880-485bfe00249e12022-11-07
0904-7237-60EA - Each0904-72370ee1a165-13f2-4f89-b39c-1c8f9e940d2812022-10-06
0904-7237-61EA - Each0904-72379d1b9365-5c30-45de-8071-c9a0262ad0c812023-01-09
0904-7237-80EA - Each0904-7237a9264169-ed21-468e-860b-7bb8a0f8406212022-11-07

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
51662-162851662-1628-1
0904-7237

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
GELATIN2G86QN327LIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
SODIUM LAURYL SULFATE368GB5141JIACT
STARCH, CORNO8232NY3SJIACT
D&C RED NO. 28767IP0Y5NHIACT
FD&C RED NO. 40WZB9127XOAIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
MAGNESIUM STEARATE70097M6I30IACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEMajor Pharmaceuticalsdca04d80-e781-40b1-e053-2995a90a70102026-02-20WarningsExact identifier
ndc (product): 0904-7237
Diphenhydramine HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst25034563-6422-daf6-e063-6394a90af9802024-10-21WarningsExact identifier
ndc (package): 51662-1628-1
ndc (product): 51662-1628
ndc11 (package): 51662162801
spl id: 25034563-6423-daf6-e063-6394a90af980
spl set id: 25034563-6422-daf6-e063-6394a90af980

Reported adverse events (FAERS/openFDA)#

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