Label at a glance#

ProductSleep Aid

Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE

Label structure16 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

Storage and handling

• store between 20–25°C (68–77°F)

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-888-333-9792

Label contents#

Full prescribing information#

Active Ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCI 50 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

• for relief of occasional sleeplessness

Do not use

OTC - DO NOT USE SECTION

• 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 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 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. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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

Other information

STORAGE AND HANDLING SECTION

• store between 20–25°C (68–77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol 400, propylene glycol, sorbitol, titanium dioxide, water

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

Distributed by:

SPL UNCLASSIFIED SECTION

Cabinet Health P.B.C.

Pouch

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sleep Aid

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	5
1020477	diphenhydramine hydrochloride 50 MG Oral Capsule	SCD	5
1020477	diphenhydramine HCl 50 MG Oral Capsule	SY	5

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
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68210-4179-3	Sleep Aid	30 in 1 POUCH	CAPSULE, LIQUID FILLED	30		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68210-4179	SLEEP AID (DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS LLC]	5	Legacy NDC, 1 package rows	20241213_2a5d285d-a4e8-4d02-8735-2a8f344b177b.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

Sleep Aid
Diphenhydramine Hydrochloride
FD&C BLUE NO. 1
GELATIN
GLYCERIN
POLYETHYLENE GLYCOL 400
PROPYLENE GLYCOL
SORBITOL
TITANIUM DIOXIDE
WATER
DIPHENHYDRAMINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68210-4179	68210-4179-3

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
Name	UNII	Kind
FD&C BLUE NO. 1	H3R47K3TBD	IACT
GELATIN	2G86QN327L	IACT
GLYCERIN	PDC6A3C0OX	IACT
POLYETHYLENE GLYCOL 400	B697894SGQ	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SORBITOL	506T60A25R	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
WATER	059QF0KO0R	IACT
DIPHENHYDRAMINE HYDROCHLORIDE	TC2D6JAD40	ACTIB

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
2904c6e1-2c52-8035-e063-6294a90aa04b			2a5d285d-a4e8-4d02-8735-2a8f344b177b	2024-12-11	Warnings	Exact identifier spl id: 2904c6e1-2c52-8035-e063-6294a90aa04b spl set id: 2a5d285d-a4e8-4d02-8735-2a8f344b177b

Reported adverse events (FAERS/openFDA)#

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