FDA.reportPublic FDA data

Diphenhydramine

Manufacturer
Safetec of America, Inc.
Effective date
2020-01-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:03:31

Label at a glance#

ProductDiphenhydramine
Active ingredientDiphenhydramine Hydrochloride
Label structure12 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 temporarily relieves these symptoms due to the common cold: runny nose sneezing

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25 mg

Purpose

OTC - PURPOSE SECTION

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
    • temporarily relieves these symptoms due to the common cold:
    • runny nose sneezing

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE 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

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

When using this product

OTC - WHEN USING SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • take every 4 to 6 hours, or as directed by a doctor
  • do not take more than 6 times in 24 hours
adults and children 12 years and over 1 to 2 capsules
children 6 to under 12 years 1 capsule
children under 6 years do not use

Other information

OTHER SAFETY INFORMATION

  • each capsule contains: calcium 20 mg
  • store at room temperature 20°-25°C (68°-77°F). Avoid high humidity. Protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, butyl paraben, D&C red #28, edible black ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methyl paraben, polysorbate 80, propyl paraben, sodium lauryl sulfate

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free: 1-800-456-7077

Principal Display Panel - 25 mg Pouch Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Safetec
of America, Inc.

DO NOT USE IF POUCH IS TORN OR DAMAGED

Manufactured for Safetec of America, Inc.
Buffalo NY 14215

Allergy Relief

Diphenhydramine HCl

antihistamine 2 Capsules

Principal Display Panel - 25 mg Pouch Label
Principal Display Panel - 25 mg Pouch Label

Principal Display Panel – 50 Pouches Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Safetec®
of America, Inc.

*Compare to the active ingredient in Benadryl®

NDC 61010-4409-1

Allergy Relief

Diphenhydramine HCl 25 mg

PUSH TO OPEN

Dispense through opening

Antihistamine

  • Itchy Watery Eyes
  • Sneezing
  • Runny Nose

TAMPER EVIDENT UNIT DOSE POUCHES

DO NOT USE IF POUCH IS TORN OR DAMAGED

50 Pouches 2 Capsules per pouchPrincipal Display Panel – 50 Pouches Carton LabelPrincipal Display Panel – 50 Pouches Carton LabelGraphic-Untitled

Principal Display Panel – 100 Pouches Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Safetec®
of America, Inc.

*Compare to the active ingredient in Benadryl®

NDC 61010-4409-2

Allergy Relief

Diphenhydramine HCl 25 mg – Antihistamine

  • Itchy Watery Eyes
  • Sneezing
  • Runny Nose

PUSH TO OPEN

Dispense through opening

TAMPER EVIDENT UNIT DOSE POUCHES

DO NOT USE IF POUCH IS TORN OR DAMAGED

100 Pouches 2 Capsules per pouch

Principal Display Panel – 100 Pouches Carton Label
Principal Display Panel – 100 Pouches Carton Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN2
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD2

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
61010-4409-02023-01-30C16284748780-1f386c649-cbf7-0266-e053-dadaa90a7c1aef6b86cc-bfc5-4e74-a806-33de9a68ce45
61010-4409-12023-01-30C16284748780-1f386c649-cbf7-0266-e053-dadaa90a7c1aef6b86cc-bfc5-4e74-a806-33de9a68ce45
61010-4409-22023-01-30C16284748780-1f386c649-cbf7-0266-e053-dadaa90a7c1aef6b86cc-bfc5-4e74-a806-33de9a68ce45

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61010-4409-0Diphenhydramine2 in 1 POUCHCAPSULE22
61010-4409-1Diphenhydramine50 in 1 BOXCAPSULE502
61010-4409-2Diphenhydramine100 in 1 BOXCAPSULE1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61010-4409DIPHENHYDRAMINE (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE [SAFETEC OF AMERICA, INC.]2Legacy NDC, 3 package rows20200129_ef6b86cc-bfc5-4e74-a806-33de9a68ce45.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61010-440961010-4409-0, 61010-4409-1, 61010-4409-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
Diphenhydramine HydrochlorideTC2D6JAD40ACTIB
benzyl alcoholLKG8494WBHIACT
butylparaben3QPI1U3FV8IACT
D&C red NO. 28767IP0Y5NHIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GELATIN2G86QN327LIACT
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
MAGNESIUM STEARATE70097M6I30IACT
METHYLPARABENA2I8C7HI9TIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLPARABENZ8IX2SC1OHIACT
SODIUM LAURYL SULFATE368GB5141JIACT

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
89099217-6a54-40a1-bfce-8bb6bc55ca5cef6b86cc-bfc5-4e74-a806-33de9a68ce452020-01-27WarningsExact identifier
spl id: 89099217-6a54-40a1-bfce-8bb6bc55ca5c
spl set id: ef6b86cc-bfc5-4e74-a806-33de9a68ce45

Reported adverse events (FAERS/openFDA)#

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