Label at a glance#

ProductSleepAid Softgels

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 15-30°C (59-86°F). Avoid high humidity. Protect from light.

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1 (718) 337-8733

Label contents#

Full prescribing information#

Active Ingredient (In Each Softgel)

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 50 mg

Purpose

OTC - PURPOSE SECTION

Nighttime sleep-aid

Uses

INDICATIONS & USAGE SECTION

for relief of occasional sleeplessness

Do not use:

WARNINGS 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.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

OTC - WHEN USING SECTION

When using this product avoid alcoholic drinks

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

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 15-30°C (59-86°F). Avoid high humidity. Protect from light.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Polyethylene Glycol, Gelatin, Sorbitol, Sorbitan Anhydrous, Glycerin, Brilliant Blue FCF.

Questions Or Comments?

OTC - QUESTIONS SECTION

Call 1 (718) 337-8733 or visit: support@nuvicare.com

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Unisom® SleepGels®

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PL0210-00 NC-Sleep Aid Soft Gels-100ct

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	2
1020477	diphenhydramine hydrochloride 50 MG Oral Capsule	SCD	2
1020477	diphenhydramine HCl 50 MG Oral Capsule	SY	2

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0384324000091	GTIN-13: 0384324000091 EAN-13: 0384324000091 GTIN-12: 384324000091 UPC-A: 384324000091 GTIN storage (14 digits): 00384324000091	PL0210-00 NC-Sleep Aid Soft Gels-100ct.jpg

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	Strength	SPL version
84324-011-01	SleepAid Softgels	100 in 1 BOTTLE	CAPSULE, LIQUID FILLED	100		2

Products#

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

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

SleepAid Softgels
Diphenhydramine Hydrochloride
DIPHENHYDRAMINE
POLYETHYLENE GLYCOL, UNSPECIFIED
GELATIN
SORBITOL
SORBITAN
GLYCERIN
FD&C BLUE NO. 1

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
84324-011	84324-011-01

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
POLYETHYLENE GLYCOL, UNSPECIFIED	3WJQ0SDW1A	IACT
GELATIN	2G86QN327L	IACT
SORBITOL	506T60A25R	IACT
SORBITAN	6O92ICV9RU	IACT
GLYCERIN	PDC6A3C0OX	IACT
FD&C BLUE NO. 1	H3R47K3TBD	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
SleepAid Softgels	DIPHENHYDRAMINE HYDROCHLORIDE	NUVICARE LLC	963c6925-dfbf-4cdc-8d13-5e10b499c4a9	2025-12-19	Warnings	Exact identifier ndc (package): 84324-011-01 ndc (product): 84324-011 ndc11 (package): 84324001101 spl id: 26f01c7e-1666-482a-9701-157642a3f431 spl set id: 963c6925-dfbf-4cdc-8d13-5e10b499c4a9

Reported adverse events (FAERS/openFDA)#

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

SleepAid Softgels