FDA.reportPublic FDA data

Diphenhydramine

Manufacturer
Rebel Distributors Corp
Effective date
2011-02-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:27:18

Label at a glance#

ProductDiphenhydramine
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

Temporarily relieves: ° hay fever or other upper respiratory allergies like: ° runny nose ° sneezing ° watery eyes ° itchy nose or throat

Dosage and administration

° take every 4-6 hours ° do not take more than 6 doses in 24 hours. Adults & children 12 years & over: 1-2 capsules Children 6 to under 12 years: 1 capsule Children under 6: ask a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25mg

Diphenhydramine HCl 50mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves: ° hay fever or other upper respiratory allergies like: ° runny nose

° sneezing ° watery eyes ° itchy nose or throat

Warnings

WARNINGS SECTION

Do not use with any other product containing Diphenhydramine HCl, including one applied topically.

Ask a doctor or pharmacist before use if you have ° trouble urinating due to enlarged prostate gland ° a breathing problem such as emphysema or chronic bronchitis ° glaucoma ° if you are taking sedatives or tranquilizers

When using this product ° avoid alcoholic drinks ° marked drowsiness may occur ° excitability may occur, especially in children ° alcohol, sedatives & tranquilizers may increase drowsiness ° be careful when driving a motor vehicle or operating machinery.

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

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

° take every 4-6 hours

° do not take more than 6 doses in 24 hours.

Adults & children 12 years & over: 1-2 capsules

Children 6 to under 12 years: 1 capsule

Children under 6: ask a doctor

Other Information

SPL UNCLASSIFIED SECTION

Store at room temperature 15°-30°C (59°-86°F)

Protect from excessive moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

Lactose Monohydrate, Silicon Dioxide, Magnesium Steareate, Black Iron Oxide, Gelatin, Sodium Lauyl Sulfate, D&C Red No. 28, FD&C Red No. 40, FD&C Blue No. 1.

Distributed by:

SDA Laboratories, Inc.

Greenwich, CT 06830

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Diphenhydramine HCl 25mgDiphenhydramine HCl 25mg

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Diphenhydramine HCl 50mgDiphenhydramine HCl 50mg

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-304-152019-09-24C16284748780-1934fe258-4d4f-48b1-e053-8cdaa90a720aDiphenhydramine Drug Facts
21695-304-202019-09-24C16284748780-1934fe258-4d4f-48b1-e053-8cdaa90a720aDiphenhydramine Drug Facts
21695-304-242019-09-24C16284748780-1934fe258-4d4f-48b1-e053-8cdaa90a720aDiphenhydramine Drug Facts
21695-304-302019-09-24C16284748780-1934fe258-4d4f-48b1-e053-8cdaa90a720aDiphenhydramine Drug Facts
21695-304-902019-09-24C16284748780-1934fe258-4d4f-48b1-e053-8cdaa90a720aDiphenhydramine Drug Facts
21695-500-152019-09-24C16284748780-1934fe258-4d4f-48b1-e053-8cdaa90a720aDiphenhydramine Drug Facts
21695-500-202019-09-24C16284748780-1934fe258-4d4f-48b1-e053-8cdaa90a720aDiphenhydramine Drug Facts
21695-500-302019-09-24C16284748780-1934fe258-4d4f-48b1-e053-8cdaa90a720aDiphenhydramine Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-304-15Diphenhydramine15 in 1 BOTTLECAPSULE151
21695-304-20Diphenhydramine20 in 1 BOTTLECAPSULE201
21695-304-24Diphenhydramine24 in 1 BOTTLECAPSULE241
21695-304-30Diphenhydramine30 in 1 BOTTLECAPSULE301
21695-304-90Diphenhydramine90 in 1 BOTTLECAPSULE901
21695-500-15Diphenhydramine15 in 1 BOTTLECAPSULE151
21695-500-20Diphenhydramine20 in 1 BOTTLECAPSULE201
21695-500-30Diphenhydramine30 in 1 BOTTLECAPSULE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-304DIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 5 package rows20110223_c46e1443-dffe-47a9-bc9a-acbe3a8b0b41.zip
21695-500DIPHENHYDRAMINE CAPSULE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 3 package rows20110223_c46e1443-dffe-47a9-bc9a-acbe3a8b0b41.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-304-15EA - Each21695-30483718c91-9a60-4d40-9f7f-bac69efb073612012-07-24
21695-304-20EA - Each21695-30402d784f9-c794-4017-a59e-81b5538445fa12012-07-24
21695-304-24EA - Each21695-30407122334-5903-4d02-a535-697b4da6a54812012-07-24
21695-304-30EA - Each21695-304a5937aa7-a403-4932-af97-1390dde3e0be12012-07-24
21695-304-90EA - Each21695-30403d58220-08a6-46b7-af4a-7d19a13a53b312012-07-24
66424-020-01EA - Each66424-02062be7459-d627-4d56-af74-b18dfb1581dc12012-07-24
66424-020-10EA - Each66424-020cc145bd4-6e21-4bfe-a7b2-2ffe0528742b12012-07-24
21695-500-15EA - Each21695-5002891dd83-816d-4e79-a5d2-b7ef2ce92be512012-07-24
21695-500-20EA - Each21695-500050591e8-514c-49fc-aae4-11e4fb698de512012-07-24
21695-500-30EA - Each21695-5003a5279b6-29e1-4203-8b2a-951b70b7debb12012-07-24
66424-021-01EA - Each66424-0219776653f-7c63-4b8b-a643-b1ff6450406412012-07-24
66424-021-10EA - Each66424-021fa4dd348-3929-4217-a7fb-c7f312f780c812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD401
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83M1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NH1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F3571
GELATININACTIVE INGREDIENT2G86QN327L1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5X1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J1

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21695-30421695-304-15, 21695-304-20, 21695-304-24, 21695-304-30, 21695-304-90
66424-020
21695-50021695-500-15, 21695-500-20, 21695-500-30
66424-021

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MAGNESIUM STEARATE70097M6I30IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
GELATIN2G86QN327LIACT
SODIUM LAURYL SULFATE368GB5141JIACT
D&C RED NO. 28767IP0Y5NHIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MAGNESIUM STEARATE70097M6I30IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
GELATIN2G86QN327LIACT
SODIUM LAURYL SULFATE368GB5141JIACT
D&C RED NO. 28767IP0Y5NHIACT
FD&C RED NO. 40WZB9127XOAIACT
FD&C BLUE NO. 1H3R47K3TBDIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE / ORAL256.4 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE / ORAL16 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHCAPSULE / ORAL1 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE / ORAL10932 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357CAPSULE / ORAL11 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE / ORAL26.3 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCAPSULE / ORAL600 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHCAPSULE / ORAL1 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE / ORAL256.4 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCAPSULE / ORAL600 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357CAPSULE / ORAL11 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE / ORAL300 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE / ORAL26.3 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE / ORAL16 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE / ORAL300 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XCAPSULE / ORAL3990 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE / ORAL10932 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XCAPSULE / ORAL3990 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HCLDIPHENHYDRAMINE HCLSDA Laboratories, Inc.437e6a13-a4ff-4f98-8973-042f224ee85e2025-01-13WarningsExact identifier
ndc (product): 66424-021
Diphenhydramine HCLDIPHENHYDRAMINE HCLSDA Laboratories, Inc.6a520986-1004-4ee6-9a47-1dfd90bb1b2c2025-01-13WarningsExact identifier
ndc (product): 66424-020
c46e1443-dffe-47a9-bc9a-acbe3a8b0b41c46e1443-dffe-47a9-bc9a-acbe3a8b0b412011-02-15WarningsExact identifier
spl id: c46e1443-dffe-47a9-bc9a-acbe3a8b0b41
spl set id: c46e1443-dffe-47a9-bc9a-acbe3a8b0b41

Reported adverse events (FAERS/openFDA)#

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