FDA.reportPublic FDA data

DIPHENHYDRAMINE HYDROCHLORIDE 50mg

Manufacturer
AMZ789 LLC
Effective date
2026-01-07
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:31:49

Label at a glance#

ProductDIPHENHYDRAMINE HYDROCHLORIDE 50mg
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure7 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 50mg

DOSAGE & ADMINISTRATION SECTION

Dipheyhydramine HCl 50mg

Use

OTC - PURPOSE SECTION

For relief of occasional sleeplessness

INDICATIONS & USAGE SECTION

for relied of occasional sleeplessness

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

for children under 12 years of age

with any other products containing diphenhydramine, even one used on skin

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

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

you are taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

avoid alcholic drinks

Stop use and ask a doctor if

OTC - STOP USE SECTION

sleeplessness presists continuously for more than 2 weeks. Insomnic may be a symptom of a series underlying medical illness

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222)

Direction

DOSAGE FORMS & STRENGTHS SECTION

adults and children 12 years and over: 1 softgel at bedtime if needed, or as directed by a doctor

INACTIVE INGREDIENT SECTION

FD&C blue #1, gelatin, glycerin, polyethylene glycol, purified water, sorbitol sorbitan solution, white ink

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RxZell

SleepAid

Dyphenhydramine HCl 50mg

Non Habit-Forming

Easy to Swallow

Package.Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 128X002MWIEVRLabel R1.jpg

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73629-001-22DIPHENHYDRAMINE HYDROCHLORIDE 50mg220 in 1 BOTTLECAPSULE, LIQUID FILLED2205

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73629-00173629-001-22

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, UNSPECIFIED3WJQ0SDW1AIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
GLYCERINPDC6A3C0OXIACT
GELATIN2G86QN327LIACT
FD&C BLUE NO. 1H3R47K3TBDIACT

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 HYDROCHLORIDE 50mgDIPHENHYDRAMINE HYDROCHLORIDE 50MGAMZ789 LLCaf0b1b08-e269-6399-e053-2a95a90ac12d2026-01-07WarningsExact identifier
ndc (package): 73629-001-22
ndc (product): 73629-001
ndc11 (package): 73629000122
spl id: 47d40d86-cbe8-fc70-e063-6394a90a2ff3
spl set id: af0b1b08-e269-6399-e053-2a95a90ac12d

Reported adverse events (FAERS/openFDA)#

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