FDA.reportPublic FDA data

Diphenhydramine HCL

Manufacturer
SDA Laboratories, Inc. | Pharbest Pharmaceuticals, Inc.
Effective date
2025-01-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:52:34

Label at a glance#

ProductDiphenhydramine HCL
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure12 sections

Indications and uses

Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies sneezing nasal congestion runny nose itchy, watery eyes

Dosage and administration

Take every 4-6 hours Do not take more than 6 doses in 24 hours. Adults and children 12 years & over 1 capsule                                      Children under 12 years ask a doctor **25 mg strength is not available in this package. Do not attempt to break capsules.

Storage and handling

Store at room temperature 15-30  degrees C (59-86 degrees F) Protect from excessive moisture

Label contents#

Full prescribing information#

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCL 50 mg

Purpose

OTC - PURPOSE SECTION

Antihistamine

Uses:

INDICATIONS & USAGE SECTION

Temporarily relieves these symptoms associated with the common cold, hay fever, or other respiratory allergies

  • sneezing
  • nasal congestion
  • runny nose
  • itchy, watery eyes

Do not use

OTC - DO NOT USE SECTION

  • With any other product containing Diphenhydramine HCL, including one applied topically.

Ask a doctor or pharmacist before use

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

  • avoid alcoholic drinks
  • marked drowsiness may occur
  • excitability may occur, especially in children
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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 and children 12 years & over1 capsule                                     
Children under 12 yearsask a doctor

**25 mg strength is not available in this package. Do not attempt to break capsules.

Other information:

STORAGE AND HANDLING SECTION

  • Store at room temperature 15-30  degrees C (59-86 degrees F)
  • Protect from excessive moisture

Inactive ingredients: 

INACTIVE INGREDIENT SECTION

Black Iron Oxide, D & C Red #28, FD & C Blue #1, FD & C Red #40, Gelatin, Lactose Monohydrate, Magnesium Stearate, Silicon Dioxide, Sodium Lauryl Sulfate

Questions? Adverse drug event call:

OTC - QUESTIONS SECTION

1-800-687-0176

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 66424-021-10

*Compare to active ingredient in BENADRYL® ALLERGY

Diphenhydramine

HCl Capsules, USP

50 mg

TAMPER-EVIDENT: DO NOT USE IF IMPRINTED SAFETY

SEAL UNDER CAP IS MISSING OR DAMAGED

ANTIHISTAMINE

1000 CAPSULES

Not for house holds with young children

SDA

Laboratories, Inc.

THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

LABELLABEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN3
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD3
1020477diphenhydramine HCl 50 MG Oral CapsuleSY3

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
66424-021-012023-06-13C16284748780-19d75b9d0-00f1-f424-e053-dadaa90a57ceDrug Facts
66424-021-102023-06-13C16284748780-19d75b9d0-00f1-f424-e053-dadaa90a57ceDrug Facts
66424-021-012020-01-31C16284748780-19d75b9d0-00f1-f424-e053-dadaa90a57ceDrug Facts
66424-021-102020-01-31C16284748780-19d75b9d0-00f1-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66424-021-01Diphenhydramine HCL100 in 1 BOTTLE, PLASTICCAPSULE1003
66424-021-10Diphenhydramine HCL1000 in 1 BOTTLE, PLASTICCAPSULE10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66424-021DIPHENHYDRAMINE HCL CAPSULE [SDA LABORATORIES, INC.]3Current NDC, Legacy NDC, 2 package rows20250115_437e6a13-a4ff-4f98-8973-042f224ee85e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
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 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66424-02166424-021-01, 66424-021-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

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

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 · 27 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE / ORAL16 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE / ORAL300 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357CAPSULE / ORAL11 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357CAPSULE / ORAL11 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE / ORAL26.3 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XCAPSULE / ORAL3990 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XCAPSULE / ORAL3990 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHCAPSULE / ORAL1 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE / ORAL16 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE / ORAL256.4 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE / ORAL26.3 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE / ORAL16 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE / ORAL10932 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCAPSULE / ORAL600 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE / ORAL10932 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE / ORAL300 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE / ORAL256.4 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCAPSULE / ORAL600 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JCAPSULE / ORAL600 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE / ORAL26.3 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHCAPSULE / ORAL1 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4CAPSULE / ORAL300 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE / ORAL10932 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357CAPSULE / ORAL11 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XCAPSULE / ORAL3990 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
D&C RED NO. 28D&C RED NO. 28767IP0Y5NHCAPSULE / ORAL1 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE / ORAL256.4 mgExact identifier — unii+route+dosage form
3 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 · 1 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 (package): 66424-021-10
ndc (package): 66424-021-01
ndc (product): 66424-021
ndc11 (package): 66424002101
ndc11 (package): 66424002110
spl id: 2ba30474-41ba-6c1a-e063-6394a90a9631
spl set id: 437e6a13-a4ff-4f98-8973-042f224ee85e

Reported adverse events (FAERS/openFDA)#

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