Sleep Aid

Product NDC: 21130-763
11-digit product format: 211300763
Labeler code: 21130
Product ID: 21130-763_8a6050ec-893c-41d4-b740-b50afd8ad1e7
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCl
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Better Living Brands, LLC
Application: M010
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2000-06-10
Substance: DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 25 mg/1
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Sleep Aid
Brand name suffix: Nighttime
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
TC2D6JAD40	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1049630	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
dec955d3-817d-454f-b146-9a631e908dbc	Available on FDA.report

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
21130-763-06	Sleep AidNighttime	200 in 1 BOTTLE	TABLET, FILM COATED	200	16
21130-763-06	Sleep AidNighttime	1 in 1 CARTON	TABLET, FILM COATED	1	16
21130-763-08	Sleep AidNighttime	2 in 1 CARTON	TABLET, FILM COATED	2	16
21130-763-08	Sleep AidNighttime	12 in 1 BLISTER PACK	TABLET, FILM COATED	12	16
21130-763-12	Sleep AidNighttime	1 in 1 CARTON	TABLET, FILM COATED	1	16
21130-763-12	Sleep AidNighttime	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100	16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]	2
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]	2
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21130-763	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [BETTER LIVING BRANDS, LLC]	15	Current NDC, Legacy NDC, 6 package rows	20250110_dec955d3-817d-454f-b146-9a631e908dbc.zip

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 4 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sleep Aid	DIPHENHYDRAMINE HCL	Cardinal Health 110, LLC. DBA Leader	1d73e966-aa4a-40a0-b42a-fda8e500756e	2026-03-13	Warnings	Exact identifier application number: M010
Sleep Aid	DIPHENHYDRAMINE HCL	Walgreens	ea1b5ec1-3c8e-437d-8e37-f38ab66d9f78	2026-03-13	Warnings	Exact identifier application number: M010
Sleep Aid Nighttime	DIPHENHYDRAMINE HCL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	8dc17b5d-1cf7-44d2-9e78-d2c6952c7d20	2026-03-11	Warnings	Exact identifier application number: M010
sleep aid	DIPHENHYDRAMINE HCL	Rite Aid Corporation	bdfd7d87-2b54-4c29-ba69-aad0fab682e7	2026-03-11	Warnings	Exact identifier application number: M010
Sleep Aid	DIPHENHYDRAMINE HCL	Wal-Mart Stores Inc	5ef35ab9-b6e8-4c88-a623-35ac9d6bd359	2026-03-05	Warnings	Exact identifier application number: M010
Sleep-Aid	DIPHENHYDRAMINE HCL	WALMART INC. (see also Equate)	84c37f4d-60f6-490e-ba8b-47d1257fa6f8	2026-02-13	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	P & L Development, LLC	59c063ad-6ea3-4f1d-a20e-5e5e062a9098	2026-02-10	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	WinCo Foods, LLC	f446e56f-c664-4092-8712-aa3f204172f8	2026-02-02	Warnings	Exact identifier application number: M010
Sleep Aid Night Time	DIPHENHYDRAMINE HCL	DOLGENCORP, LLC	d805fab3-9dca-497f-bdc6-c8a7b1736109	2026-01-27	Warnings	Exact identifier application number: M010
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	SOFTGEL HEALTHCARE PRIVATE LIMITED	0e45d0e8-3741-7cee-e063-6394a90a2de5	2026-01-27	Warnings	Exact identifier application number: M010
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	Softgel Healthcare Pvt Ltd	335b09c6-ee5d-ebdf-e063-6294a90abd12	2026-01-27	Warnings	Exact identifier application number: M010
Diphenhydramine hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Softgel Healthcare Pvt Ltd	32033991-a4f0-f767-e063-6394a90a0b06	2026-01-27	Warnings	Exact identifier application number: M010
NIGHTTIME SLEEP AID	DIPHENHYDRAMINE HYDROCHLORIDE	Wal-Mart Stores Inc	90506598-046f-48d3-b8f5-d6ead0333812	2026-01-27	Warnings	Exact identifier application number: M010
DORMMY-LON	DIPHENHYDRAMINE HYDROCHLORIDE	Haendel Farma, S.A. de C.V.	562db961-83cb-4b74-9f34-fecee2c1be17	2026-01-27	Warnings	Exact identifier application number: M010
Sleep Aid Nighttime	DIPHENHYDRAMINE HCL	Better Living Brands, LLC	dec955d3-817d-454f-b146-9a631e908dbc	2026-01-27	Warnings	Exact identifier application number: M010 ndc (product): 21130-763
NIGHTTIME SLEEP AID	DIPHENHYDRAMINE HYDROCHLORIDE	Prodose, Inc.	c4bc3efd-8ca8-22fe-e053-2a95a90aed45	2026-01-26	Warnings	Exact identifier application number: M010
NIGHTTIME SLEEP AID	DIPHENHYDRAMINE HYDROCHLORIDE	WALGREEN COMPANY	f000d0b5-8ee8-4db0-99fe-aae5ed20c98e	2026-01-19	Warnings	Exact identifier application number: M010
Unisom SleepMinis Nighttime Sleep-Aid	DIPHENHYDRAMINE HCL	Chattem, Inc.	a9a44c2f-65eb-4a5a-9e72-43652dce57f7	2026-01-14	Warnings	Exact identifier application number: M010
Unisom SleepMelts Nighttime Sleep-Aid	DIPHENHYDRAMINE HYDROCHLORIDE	Chattem, Inc.	9105f4f1-7f94-408d-a025-83afb68dc9f0	2026-01-14	Warnings	Exact identifier application number: M010
Rest Simply	DIPHENHYDRAMINE HYDROCHLORIDE	HYVEE INC	462ca6cd-8eec-09df-e063-6294a90ac880	2026-01-13	Warnings	Exact identifier application number: M010

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1049630	diphenhydrAMINE HCl 25 MG Oral Tablet	PSN	dec955d3-817d-454f-b146-9a631e908dbc	16
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	dec955d3-817d-454f-b146-9a631e908dbc	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
21130-763-06	21130076306	1 BOTTLE in 1 CARTON (21130-763-06) / 200 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2000-06-10	0000-00-00	No	No	Current
21130-763-08	21130076308	2 BLISTER PACK in 1 CARTON (21130-763-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK	2 blister pack	2000-06-10	0000-00-00	No	No	Current
21130-763-12	21130076312	1 BOTTLE, PLASTIC in 1 CARTON (21130-763-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC		2000-06-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Signature Select 44-367	Better Living Brands, LLC \| LNK International, Inc.	2026-01-27	HUMAN OTC DRUG LABEL	16