Sleep Aid

Product NDC: 49035-367
11-digit product format: 490350367
Labeler code: 49035
Product ID: 49035-367_7affd665-60d0-4b01-96be-a9f2db49f2bf
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCl
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Wal-Mart Stores Inc
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
cfddfdeb-701f-452d-876d-8003e6fcefe3	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
49035-367-08	Sleep AidNighttime	12 in 1 BLISTER PACK	TABLET, FILM COATED	12	15
49035-367-08	Sleep AidNighttime	2 in 1 CARTON	TABLET, FILM COATED	2	15
49035-367-12	Sleep AidNighttime	1 in 1 CARTON	TABLET, FILM COATED	1	15
49035-367-12	Sleep AidNighttime	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100	15
49035-367-42	Sleep AidNighttime	12 in 1 BLISTER PACK	TABLET, FILM COATED	12	15

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 [WAL-MART STORES INC]	1
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49035-367	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WAL-MART STORES INC]	14	Current NDC, Legacy NDC, 5 package rows	20240612_cfddfdeb-701f-452d-876d-8003e6fcefe3.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 10 of 13 · 259 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RIGHT REMEDIES Maximum Strength Nighttime Sleep-Aid Softgel	DIPHENHYDRAMINE HYDROCHLORIDE	Strive Pharmaceuticals Inc.	2d64f5c2-dfa9-e5f5-e063-6294a90a0711	2025-03-19	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid Maximum Strength	DIPHENHYDRAMINE HCL	Harris Teeter, LLC	20f8fe27-f97f-4278-a5a8-79b5fc47ef3b	2025-03-13	Warnings	Exact identifier application number: M010
Sleep Aid Maximum Strength	DIPHENHYDRAMINE HCL	Harris Teeter, LLC	322a71bb-fc68-4a03-8a24-20cbdbe6d91b	2025-03-13	Warnings	Exact identifier application number: M010
REVASOL SLEEP AID	DIPHENHYDRAMINE HCL	Rnv LLC	30131010-be70-c940-e063-6394a90a190a	2025-03-11	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	L.N.K. International, Inc.	1a7189ba-2d52-44fc-83a4-b9f6156c62ff	2025-03-07	Warnings	Exact identifier application number: M010
meijer NIGHTTIME Sleep Aid SOFTGEL	DIPHENHYDRAMINE HYDROCHLORIDE	Meijer, Inc.	1bede4cd-bf55-8b84-e063-6394a90aa5c9	2025-02-19	Warnings	Exact identifier application number: M010
PHARBEDRYL	DIPHENHYDRAMINE HCL 50MG	Ulai Health LLC	135293fb-5674-4638-be55-b968cf51257e	2025-01-20	Warnings	Exact identifier application number: M010
Allergy Relief 25 mg	DIPHENHYDRAMINE HCL 25MG	Ulai Health LLC	751f13d4-c4d6-47a5-b40d-1563de08c048	2025-01-12	Warnings	Exact identifier application number: M010
RoboCough	DEXTROMETHORPHAN HBR	DXM Pharmacuetical, Inc.	32fa7a09-8624-44c1-b9e4-8a8f0594292b	2025-01-10	Warnings	Exact identifier application number: M010
SleepAid (Diphenhydramine HCL)	DIPHENHYDRAMINE HCL	APNAR PHARMA LP	faaf5d51-d81d-3acc-e053-6294a90ae08f	2025-01-09	Warnings	Exact identifier application number: M010
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	Strive Pharmaceuticals Inc.	971515fa-b4d2-1197-e053-2995a90a838d	2025-01-03	Warnings	Exact identifier application number: M010
Nighttime Sleep-Aid Softgel	DIPHENHYDRAMINE HYDROCHLORIDE	CVS PHARMACY, INC	8b0fa259-6702-4667-bac6-f7d0b0839ae0	2025-01-01	Warnings	Exact identifier application number: M010
Sleep Aid Nighttime	DIPHENHYDRAMINE HYDROCHLORIDE	TOPCO ASSOCIATES LLC	9f1c078d-e537-4ec0-8ae9-54c98282be29	2024-12-31	Warnings	Exact identifier application number: M010
Discount Drugmart Nighttime Sleep-Aid	DIPHENHYDRAMINE HCL	Discount Drug Mart, Inc	d6d77c2e-42b3-48f0-a662-3872155ef34d	2024-12-18	Warnings	Exact identifier application number: M010
Kroger Nighttime Sleep-Aid	DIPHENHYDRAMINE HCL	THE KROGER CO	98437a72-1b98-4301-b92f-0c17b305cf59	2024-12-18	Warnings	Exact identifier application number: M010
equate nighttime sleep aid	DIPHENHYDRAMINE HYDROCHLORIDE	WALMART INC.	6e162152-b414-470c-b146-649d99870577	2024-12-17	Warnings	Exact identifier application number: M010
Quality Choice Nighttime Sleep-Aid	DIPHENHYDRAMINE HYDROCHLORIDE	Chain Drug Marketing Association, Inc.	e8b2858b-a737-c500-e053-2995a90adba6	2024-12-16	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	Strive Pharmaceuticals Inc.	f99cc210-b946-42a2-9164-8aa5308c5418	2024-12-11	Warnings	Exact identifier application number: M010
CalmCo Sleep Aid Gummy Bite	DIPHENHYDRAMINE HCL	CalmCo LLC	0c534cbd-40e6-8af0-e063-6394a90a5605	2024-12-07	Warnings	Exact identifier application number: M010
Somnapure Clinical Strength	DIPHENHYDRAMINE HYDROCHLORIDE	Force Factor Brands LLC	063517c0-bcb1-46dd-85f1-bbb2f24274ef	2024-12-06	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	cfddfdeb-701f-452d-876d-8003e6fcefe3	15
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	cfddfdeb-701f-452d-876d-8003e6fcefe3	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49035-367-08	49035036708	2 BLISTER PACK in 1 CARTON (49035-367-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK	2 blister pack	2000-06-10	0000-00-00	No	No	Current
49035-367-12	49035036712	1 BOTTLE, PLASTIC in 1 CARTON (49035-367-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC		2000-06-10	0000-00-00	No	No	Current
49035-367-42	49035036742	12 TABLET, FILM COATED in 1 BLISTER PACK (49035-367-42)		2000-06-10	0000-00-00	No	No	Current