Label at a glance#

ProductSleep Aid

Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE

Label structure9 sections

Dosage and administration

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

Storage and handling

store at room temperature 15° to 30°C (59° to 86°F) and avoid excessive heat

Contacts and useful links#

PhonePoison Help1-800-222-1222

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 50mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep aid

Use(s)

INDICATIONS & USAGE SECTION

for relief of occasional sleeplessness

Warnings

WARNINGS SECTION

Do not use

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 before use if

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

Pregnancy/Breastfeeding

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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

SPL UNCLASSIFIED SECTION

do not use if imprinted safety seal under cap is broken or missing or
do not use if blister unit is torn or open

Storage

STORAGE AND HANDLING SECTION

store at room temperature 15° to 30°C (59° to 86°F) and avoid excessive heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1020477	diphenhydrAMINE (Oral Pill)	diphenhydramine hydrochloride 50 MG Oral Capsule	SCD Active

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1020477	diphenhydrAMINE HCl 50 MG Oral Capsule	PSN	8
1020477	diphenhydramine hydrochloride 50 MG Oral Capsule	SCD	8
1020477	diphenhydramine HCl 50 MG Oral Capsule	SY	8

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DIPHENHYDRAMINE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69168-410-03	Sleep Aid	250 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	250	8
69168-410-09	Sleep Aid	10 in 1 CARTON	CAPSULE, LIQUID FILLED	10	8
69168-410-32	Sleep Aid	100 in 1 BOTTLE	CAPSULE, LIQUID FILLED	100	8
69168-410-98	Sleep Aid	200 in 1 BOTTLE	CAPSULE, LIQUID FILLED	200	8

Products#

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

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

Sleep Aid
Diphenhydramine HCl
DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE
FD&C BLUE NO. 1
GELATIN
GLYCERIN
POLYETHYLENE GLYCOL, UNSPECIFIED
WATER
SORBITOL SOLUTION

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69168-410	69168-410-09, 69168-410-03, 69168-410-32, 69168-410-98

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
Name	UNII	Kind
DIPHENHYDRAMINE HYDROCHLORIDE	TC2D6JAD40	ACTIB
FD&C BLUE NO. 1	H3R47K3TBD	IACT
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
WATER	059QF0KO0R	IACT
SORBITOL SOLUTION	8KW3E207O2	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sleep Aid	DIPHENHYDRAMINE HCL	Allegiant Health	ec57db48-0f3a-4b12-8633-b45a4366c269	2020-11-06	Warnings	Exact identifier ndc (package): 69168-410-32 ndc (package): 69168-410-98 ndc (package): 69168-410-09 ndc (package): 69168-410-03 ndc (product): 69168-410 ndc11 (package): 69168041003 ndc11 (package): 69168041098 ndc11 (package): 69168041009 ndc11 (package): 69168041032 spl id: 8844ab77-4a39-4e32-b936-99441706e9b8 spl set id: ec57db48-0f3a-4b12-8633-b45a4366c269

Reported adverse events (FAERS/openFDA)#

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

Sleep Aid