FDA.reportPublic FDA data

Diphenhydramine Hydrochloride

Manufacturer
Strive Pharmaceuticals Inc.
Effective date
2025-01-03
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:52:10

Label at a glance#

ProductDiphenhydramine Hydrochloride
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

• for relief of occasional sleeplessness • reduces time to fall asleep if you have difficulty falling asleep

Dosage and administration

adults and children  12 years and over take 1 softgel (50mg) at bedtime  if needed, or as directed by a  doctor children under 12  years do not use

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCI 50 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

• for relief of occasional sleeplessness
• reduces time to fall asleep if you have difficulty falling asleep

Warnings

WARNINGS SECTION

Do not use
• for children under 12 years of age
• with any other product containing diphenhydramine, even one used on skin
• with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products

Ask a doctor before use if you have
• glaucoma
• heart disease
• a breathing problem such as emphysema, asthma, or chronic bronchitis
• difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives, tranquilizers, or any other sleep aid

When using this product • avoid alcoholic beverages and other drugs that cause drowsiness. Be careful when driving a motor vehicle or operating machinery.

Stop use and ask a doctor if sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

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.
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.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children  12 years and overtake 1 softgel (50mg) at bedtime  if needed, or as directed by a  doctor
children under 12  yearsdo not use

Other information

OTHER SAFETY INFORMATION

• store at 20-25°C (68-77°F)
• avoid excessive heat above 40°C (104°F)
• protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

edible ink, FD&C blue #1, gelatin, glycerin, isopropyl alcohol, medium chain triglycerides, polyethylene glycol, povidone, purified water, sorbitol sorbitan solution

Questions or comments?

OTC - QUESTIONS SECTION

1-888-577-8033 Monday-Friday 8am-4pm EST

SPL UNCLASSIFIED SECTION

Compare to the active ingredient of Unisom® SleepGels®*

Maximum Strength

fall asleep fast safe, non-habit forming

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING FROM BOTTLE

This product i is not manufactured or distributed by Chatem, Inc., owner of the registered trademark Unisom®.

Distributed by: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816

Product of UAE

Packaged and Quality Assured in the USA

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Strive-785-1Strive-785-1

Strive-785-2Strive-785-2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN5
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD5
1020477diphenhydramine HCl 50 MG Oral CapsuleSY5

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
70692-785-612022-04-12C16284748780-1d6a99b39-b3e1-a426-e053-dadaa90af4c2Nighttime Sleep-Aid Diphenhydramine HCl 50mg (Blue Softgel)
70692-785-612022-01-28C16284748780-1d6a99b39-b3e1-a426-e053-dadaa90af4c2Nighttime Sleep-Aid Diphenhydramine HCl 50mg (Blue Softgel)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70692-785-15Diphenhydramine Hydrochloride150 in 1 BOTTLECAPSULE, LIQUID FILLED1505
70692-785-61Diphenhydramine Hydrochloride16 in 1 BOTTLECAPSULE, LIQUID FILLED165
70692-785-71Diphenhydramine Hydrochloride275 in 1 BOTTLECAPSULE, LIQUID FILLED2755

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70692-785DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED [STRIVE PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 3 package rows20250112_971515fa-b4d2-1197-e053-2995a90a838d.zip

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
70692-78570692-785-61, 70692-785-15, 70692-785-71

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
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN, UNSPECIFIED2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL ALCOHOLND2M416302IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
SORBITAN6O92ICV9RUIACT

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
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.971515fa-b4d2-1197-e053-2995a90a838d2025-01-03WarningsExact identifier
ndc (package): 70692-785-61
ndc (package): 70692-785-15
ndc (package): 70692-785-71
ndc (product): 70692-785
ndc11 (package): 70692078571
ndc11 (package): 70692078515
ndc11 (package): 70692078561
spl id: aa185f21-9410-4918-b9e5-27f7891578b0
spl set id: 971515fa-b4d2-1197-e053-2995a90a838d

Reported adverse events (FAERS/openFDA)#

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