FDA.reportPublic FDA data

Diphenhydramine Hydrochloride 25mg

Manufacturer
Strive Pharmaceuticals Inc
Effective date
2020-11-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:33:43

Label at a glance#

ProductDiphenhydramine Hydrochloride 25mg
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 25mg

INACTIVE INGREDIENT SECTION

croscarmellose sodium, D&C blue #4 aluminium lake, dibasic calcium phosphate, hydroxy propyl methyl cellulose, isopropyl alcohol, magnesium stearate, microcrystalline cellulose, polyethyl;ene glycol, talc, titanium dioxide

DOSAGE & ADMINISTRATION SECTION

  • take with a full glass of water
  • do not take more than directed
adults and children 12 years of age and over2 caplets at bedtime if needed, or as directed by a doctor
children under 12 years of agedo not use

INDICATIONS & USAGE SECTION

for relief of occasional sleeplessness

WARNINGS SECTION

Do not use

  • in children under 12 years of age
  • with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

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

Ask a doctor or a pharmacist before use if

you are taking sedatives or tranquilzers

When using this product

  • avoid alcoholic drinks
  • drowsiness will occur
  • do not drive a motor vehicle or operate machinery

Stop use and ask a doctor if

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness

If pregnant or breast-feeding,

ask a health professional before use

Keep out of reach of children

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

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

OTC - PURPOSE SECTION

Nighttime sleep-aid

OTHER SAFETY INFORMATION

  • store at room temperature between 20 ºC - 25 ºC (68 ºF - 77 ºF)
  • avoid high humidity
  • protect from light

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LB11101LB11101CT11101CT11101CT11141CT11141

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN3
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD3

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
70692-111-012022-01-28C16284748780-1d6a99b39-7f00-a426-e053-dadaa90af4c2Nighttime Sleep-Aid Sleep - Dormir (Diphenhydramine HCl 25mg) - Blue caplet
70692-111-412022-01-28C16284748780-1d6a99b39-7f00-a426-e053-dadaa90af4c2Nighttime Sleep-Aid Sleep - Dormir (Diphenhydramine HCl 25mg) - Blue caplet

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70692-111-01Diphenhydramine Hydrochloride 25mg100 in 1 PACKAGETABLET1003
70692-111-41Diphenhydramine Hydrochloride 25mg4 in 1 PACKAGETABLET43

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70692-111DIPHENHYDRAMINE HYDROCHLORIDE 25MG TABLET [STRIVE PHARMACEUTICALS INC]3Legacy NDC, 2 package rows20201117_91e5bd4a-b981-5b26-e053-2a95a90af9fe.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
70692-11170692-111-41, 70692-111-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
D&C BLUE NO. 40KSY80VYS3IACT
HYPROMELLOSES3NXW29V3WOIACT
ISOPROPYL ALCOHOLND2M416302IACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
TALC7SEV7J4R1UIACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
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
b43d643e-eb34-b295-e053-2995a90a7b6f91e5bd4a-b981-5b26-e053-2a95a90af9fe2020-11-16WarningsExact identifier
spl id: b43d643e-eb34-b295-e053-2995a90a7b6f
spl set id: 91e5bd4a-b981-5b26-e053-2a95a90af9fe

Reported adverse events (FAERS/openFDA)#

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