FDA.reportPublic FDA data

Diphenhydramine Hydrochloride Capsules USP 50 mg

Manufacturer
SOFTGEL HEALTHCARE PRIVATE LIMITED
Effective date
2026-01-27
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:34:49

Label at a glance#

ProductDIPHENHYDRAMINE HYDROCHLORIDE
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure14 sections

Indications and uses

for relief of occasional sleeplessness

Dosage and administration

adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each softgel)

Diphenhydramine Hydrochloride USP 50 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

  • for relief of occasional sleeplessness

Warnings

WARNINGS SECTION

Do not use

  • for 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

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

OTC - ASK DOCTOR/PHARMACIST SECTION

taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

avoid alcoholic drinks

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

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

  • adults and children 12 years of age and over: 1 softgel (50 mg) at bedtime if needed, or as directed by a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Propylene Glycol, Polyethylene Glycol 600, Polyethylene Glycol 400, Gelatin, Glycerin, Sorbitol Sorbitan Solution, FD & C Blue No.1, Purified Water

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the active ingredient Unisom ® SleepGels ®

SleepGels

NDC 35916-0438-1

Diphenhydramine Hydrochloride Capsules USP 50 mg

NIGHTTIME SLEEP-AID

♦ fall asleep fast ♦ sleep soundly

♦ safe, non-habit forming

100 SoftGels**

**liquid-filled capsules

one softgel per dose

bottlebottle

Bulk Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1020477diphenhydrAMINE HCl 50 MG Oral CapsulePSN4
1020477diphenhydramine hydrochloride 50 MG Oral CapsuleSCD4
1020477diphenhydramine HCl 50 MG Oral CapsuleSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130335916043811GTIN-13: 0335916043811
EAN-13: 0335916043811
GTIN-12: 335916043811
UPC-A: 335916043811
GTIN storage (14 digits): 00335916043811		Diphenhydramine 50mg Bottle Label.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35916-0438-1DIPHENHYDRAMINE HYDROCHLORIDE100 in 1 BOTTLECAPSULE, LIQUID FILLED1004
35916-0438-3DIPHENHYDRAMINE HYDROCHLORIDE1000 in 1 BAGCAPSULE, LIQUID FILLED10004

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
35916-043835916-0438-1, 35916-0438-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL 600NL4J9F21N9IACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
SORBITOL506T60A25RIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT

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 HYDROCHLORIDESOFTGEL HEALTHCARE PRIVATE LIMITED0e45d0e8-3741-7cee-e063-6394a90a2de52026-01-27WarningsExact identifier
ndc (package): 35916-0438-1
ndc (package): 35916-0438-3
ndc (product): 35916-0438
ndc11 (package): 35916043803
ndc11 (package): 35916043801
spl id: 47c5b5fc-5f4a-cd15-e063-6294a90a45aa
spl set id: 0e45d0e8-3741-7cee-e063-6394a90a2de5

Reported adverse events (FAERS/openFDA)#

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