FDA.reportPublic FDA data

Diphenhydramine Hydrochloride

Manufacturer
Strive Pharmaceuticals Inc.
Effective date
2022-04-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:49:09

Label at a glance#

ProductDiphenhydramine Hydrochloride
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25mg

OTC - PURPOSE SECTION

Antihistamine

INACTIVE INGREDIENT SECTION

polyethylene glycol 400, propylene glycol, gelatin, glycerin, sorbitol 70%, povidone k-30

DOSAGE & ADMINISTRATION SECTION

If needed, repeat dose every 4 to 6 hours donot take more than 6 doses in 24 hours

AgeDaily dosage
Adults and children 12 years of age or older1 to 2 softgel
Children 6 to under 12 years1 softgel
Children under 6 years of agedo not use this product

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms due to hay fever or other respiratory allergies:

  • runny nose
  • itching of the nose or throat
  • itchy, watery eyes

temporarily relieves these symptoms due to the common cold:

  • runny nose
  • sneezing

WARNINGS SECTION

Do not use

  • to make a child sleepy
  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

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, expecially 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.

OVERDOSAGE SECTION

Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

OTHER SAFETY INFORMATION

  • store between 20-25°C (68-77ºF), Excursions permitted between 15°C-30°C (59-86ºF).
  • TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CT78302CT78302

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049909diphenhydrAMINE HCl 25 MG Oral CapsulePSN4
1049909diphenhydramine hydrochloride 25 MG Oral CapsuleSCD4

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
70692-783-022024-01-30C16284748780-1d6a99b39-98dc-a426-e053-dadaa90af4c2ALLERGY RELIEF Diphenhydramine HCl 25mg
70692-783-022022-04-12C16284748780-1d6a99b39-98dc-a426-e053-dadaa90af4c2ALLERGY RELIEF Diphenhydramine HCl 25mg
70692-783-022022-01-28C16284748780-1d6a99b39-98dc-a426-e053-dadaa90af4c2ALLERGY RELIEF Diphenhydramine HCl 25mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70692-783-02Diphenhydramine Hydrochloride20 in 1 BLISTER PACKCAPSULE, LIQUID FILLED204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70692-783DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED [STRIVE PHARMACEUTICALS INC.]4Legacy NDC, 1 package rows20220413_73a299b4-71ad-e906-e053-2991aa0a96eb.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70692-78370692-783-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL 400B697894SGQIACT
SORBITOL506T60A25RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
GELATIN2G86QN327LIACT
POVIDONE K30U725QWY32XIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB

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
dc7922e3-5696-0d5b-e053-2a95a90aa49273a299b4-71ad-e906-e053-2991aa0a96eb2022-04-12WarningsExact identifier
spl id: dc7922e3-5696-0d5b-e053-2a95a90aa492
spl set id: 73a299b4-71ad-e906-e053-2991aa0a96eb

Reported adverse events (FAERS/openFDA)#

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