FDA.reportPublic FDA data

Diphenhydramine Hydrochloride

Manufacturer
Bryant Ranch Prepack
Effective date
2025-01-31
Label type
HUMAN OTC DRUG LABEL
Version
102
Source
full-release
Hydrated at
2026-06-01 00:56:15

Label at a glance#

ProductDiphenhydramine Hydrochloride
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure11 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

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each capsule)
Diphenhydramine HCl 25 mg

OTC - PURPOSE SECTION

Purpose
Antihistamine

Uses

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

WARNINGS SECTION

OTC - DO NOT USE SECTION

 to make a child sleepy

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

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

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

Directions

DOSAGE & ADMINISTRATION 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 agedo not use this product
in children under 6 years of age

Other information

OTHER SAFETY INFORMATION

 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

Questions or comments?

OTC - QUESTIONS SECTION

1-800-616-2471

SPL UNCLASSIFIED SECTION

Distributed by: MAJOR® PHARMACEUTICALS, Indianapolis, IN 46268

Product of China. Manufactured and packaged in the USA using domestic and imported ingredients.

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Benadryl®.

To preserve quality and freshness, keep bottle tightly closed.

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.

HOW SUPPLIED

How Supplied Section

Diphenhydramine 25 mg Capsules

  • NDC 71335-2257-1: 30 Tablets in a BOTTLE
  • NDC 71335-2257-2: 20 Tablets in a BOTTLE
  • NDC 71335-2257-3: 42 Tablets in a BOTTLE
  • NDC 71335-2257-4: 24 Tablets in a BOTTLE
  • NDC 71335-2257-5: 15 Tablets in a BOTTLE
  • NDC 71335-2257-6: 60 Tablets in a BOTTLE
  • NDC 71335-2257-7: 10 Tablets in a BOTTLE
  • NDC 71335-2257-8: 6 Tablets in a BOTTLE
  • NDC 71335-2257-9: 90 Tablets in a BOTTLE
  • NDC 71335-2257-0: 100 Tablets in a BOTTLE

Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Diphenhydramine 25 mg Capsule

Label
Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN102
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD102

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
71335-2257-0Diphenhydramine Hydrochloride100 in 1 BOTTLECAPSULE100102
71335-2257-1Diphenhydramine Hydrochloride30 in 1 BOTTLECAPSULE30102
71335-2257-2Diphenhydramine Hydrochloride20 in 1 BOTTLECAPSULE20102
71335-2257-3Diphenhydramine Hydrochloride42 in 1 BOTTLECAPSULE42102
71335-2257-4Diphenhydramine Hydrochloride24 in 1 BOTTLECAPSULE24102
71335-2257-5Diphenhydramine Hydrochloride15 in 1 BOTTLECAPSULE15102
71335-2257-6Diphenhydramine Hydrochloride60 in 1 BOTTLECAPSULE60102
71335-2257-7Diphenhydramine Hydrochloride10 in 1 BOTTLECAPSULE10102
71335-2257-8Diphenhydramine Hydrochloride6 in 1 BOTTLECAPSULE6102
71335-2257-9Diphenhydramine Hydrochloride90 in 1 BOTTLECAPSULE90102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2257DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]102Current NDC, 10 package rows20250228_f40bfdfc-1cb4-4604-9790-fb8d1d5173c6.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2257-1EA - Each71335-225758b99513-9485-4de7-a0e3-2551287c0f4a12025-12-16
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
71335-225771335-2257-1, 71335-2257-2, 71335-2257-3, 71335-2257-4, 71335-2257-5, 71335-2257-6, 71335-2257-7, 71335-2257-8, 71335-2257-9, 71335-2257-0
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
D&C RED NO. 28767IP0Y5NHIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
MAGNESIUM STEARATE70097M6I30IACT
GELATIN, UNSPECIFIED2G86QN327LIACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
SODIUM LAURYL SULFATE368GB5141JIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
STARCH, CORNO8232NY3SJIACT

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 HYDROCHLORIDEBryant Ranch Prepackf40bfdfc-1cb4-4604-9790-fb8d1d5173c62025-01-31WarningsExact identifier
ndc (package): 71335-2257-4
ndc (package): 71335-2257-6
ndc (package): 71335-2257-9
ndc (package): 71335-2257-0
ndc (package): 71335-2257-1
ndc (package): 71335-2257-2
ndc (package): 71335-2257-3
ndc (package): 71335-2257-8
ndc (package): 71335-2257-7
ndc (package): 71335-2257-5
ndc (product): 71335-2257
ndc11 (package): 71335225706
ndc11 (package): 71335225704
ndc11 (package): 71335225703
ndc11 (package): 71335225702
ndc11 (package): 71335225705
ndc11 (package): 71335225709
ndc11 (package): 71335225701
ndc11 (package): 71335225707
ndc11 (package): 71335225700
ndc11 (package): 71335225708
spl id: 00ce4a39-6dad-4e7d-878a-a34b3a06f92d
spl set id: f40bfdfc-1cb4-4604-9790-fb8d1d5173c6

Reported adverse events (FAERS/openFDA)#

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