Sleep Aid

Product NDC: 0363-0367
11-digit product format: 003630367
Labeler code: 0363
Product ID: 0363-0367_959cf59d-54ea-4e34-90ea-27261017b2a3
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCl
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Walgreen Company
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0363-0367	0363-0367-91	D	Discontinued by firm		2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
ec3618dd-8713-4f3c-b639-fc240021c7be	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
0363-0367-08	Sleep AidNighttime	12 in 1 BLISTER PACK	TABLET, FILM COATED	12	19
0363-0367-08	Sleep AidNighttime	2 in 1 CARTON	TABLET, FILM COATED	2	19
0363-0367-12	Sleep AidNighttime	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100	19
0363-0367-12	Sleep AidNighttime	1 in 1 CARTON	TABLET, FILM COATED	1	19
0363-0367-13	Sleep AidNighttime	250 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	250	19
0363-0367-13	Sleep AidNighttime	1 in 1 CARTON	TABLET, FILM COATED	1	19
0363-0367-91	Sleep AidNighttime	1 in 1 CARTON	TABLET, FILM COATED	1	19
0363-0367-91	Sleep AidNighttime	125 in 1 BOTTLE	TABLET, FILM COATED	125	19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0363-0367-08	EA - Each	0363-0367	a34df953-b3d2-4a1f-bc09-73355ba1b578	1	2015-10-02
0363-0367-12	EA - Each	0363-0367	cabdb671-984e-48fc-bdd8-7ac4e6eb091b	1	2015-07-20

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 [WALGREEN CO.]	5
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WALGREEN CO.]	5
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WALGREEN CO.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WALGREEN CO.]	5
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WALGREEN CO.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WALGREEN CO.]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WALGREEN CO.]	5
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WALGREEN CO.]	5
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WALGREEN CO.]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WALGREEN CO.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WALGREEN CO.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-0367	SLEEP AID NIGHTTIME (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WALGREEN COMPANY]	18	Current NDC, Legacy NDC, 8 package rows	20250512_ec3618dd-8713-4f3c-b639-fc240021c7be.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 12 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nighttime sleep aid Maximum Strength	DIPHENHYDRAMINE HYDROCHLORIDE	Best Choice (Valu Merchandisers Company)	40e73317-5126-4961-8f28-60899ffbec5a	2024-02-20	Warnings	Exact identifier application number: M010
Nighttime sleep aid Maximum Strength	DIPHENHYDRAMINE HYDROCHLORIDE	Best Choice (Valu Merchandisers Company)	2424fb95-06e2-49e7-aea0-7797a37aef4d	2024-02-20	Warnings	Exact identifier application number: M010
Diphenhydramine Hydrochloride	DIPHENHYDRAMINE HYDROCHLORIDE	CVS Pharmacy, Inc	f5b609e1-e63b-2e3b-e053-2995a90a76b9	2024-02-12	Warnings	Exact identifier application number: M010
Kroger Nighttime Sleep Aid CAPLET	DIPHENHYDRAMINE HYDROCHLORIDE	The Kroger Co.	f0f3f58d-9457-4697-98e6-ef52d350cf67	2024-01-29	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	NIGHTTIME SLEEP AID	Allegiant Health	88feea1d-c961-45e9-b9a6-1418b970aaba	2024-01-16	Warnings	Exact identifier application number: M010
Sleep-Aid Diphenhydramine HCl	DIPHENHYDRAMINE HYDROCHLORIDE	Cardinal Health 110, LLC. DBA Leader	4283558d-62df-4297-bc85-a4e06681a920	2024-01-11	Warnings	Exact identifier application number: M010
Nighttime Sleep-Aid	DIPHENHYDRAMINE HYDROCHLORIDE	DeMoulas Market Basket	d3f35102-94ed-4da0-9c29-312e5468fa05	2023-12-29	Warnings	Exact identifier application number: M010
nighttime sleep-aid	DIPHENHYDRAMINE HCL	Bionpharma Inc.	c0074c77-287e-6c26-e053-2995a90a4d31	2023-12-26	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYRAMINE HYDROCHLORIDE	TARGET CORPORATION	fac83dad-f6fd-3316-e053-6394a90a99aa	2023-12-21	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENYDRAMINE HYDROCHLORIDE	TARGET CORPORATION	fc7ed67f-bac9-f9ed-e053-6294a90ad9a1	2023-12-16	Warnings	Exact identifier application number: M010
Sleep-Aid, Circle K	DIPHENHYDRAMINE HCL CAPLET, 25MG	Lil' Drug Store Products, Inc.	d3ad24c4-44ba-6451-e053-2a95a90a1339	2023-12-14	Warnings	Exact identifier application number: M010
Nighttime Sleep-Aid	DIPHENHYDRAMINE HCL	VALU MERCHANDISERS COMPANY	fed2f7ae-2829-f967-e053-6294a90adc0a	2023-10-12	Warnings	Exact identifier application number: M010
Sleep Aid	SLEEP AID	Better Living Brands LLC	2b730fa5-47f9-468d-86ed-0d49d9cd8dc4	2023-07-06	Warnings	Exact identifier application number: M010
Diphenhydramine HCl 25mg	SLEEP AID	Allegiant Health	2890e4ba-d642-437d-8a86-24996a74e027	2021-11-23	Warnings	Exact identifier application number: M010
Sleep Aid	SLEEP AID	Allegiant Health	9a0b347e-5719-42f3-9050-df5165495e88	2021-10-14	Warnings	Exact identifier application number: M010
Sleep Aid	DIPHENHYDRAMINE HCL	Allegiant Health	ec57db48-0f3a-4b12-8633-b45a4366c269	2020-11-06	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	ec3618dd-8713-4f3c-b639-fc240021c7be	19
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	ec3618dd-8713-4f3c-b639-fc240021c7be	19

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0363-0367-08	00363036708	2 BLISTER PACK in 1 CARTON (0363-0367-08) / 12 TABLET, FILM COATED in 1 BLISTER PACK	2 blister pack	2000-06-10	0000-00-00	No	No	Current
0363-0367-12	00363036712	1 BOTTLE, PLASTIC in 1 CARTON (0363-0367-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC		2000-06-10	0000-00-00	No	No	Current
0363-0367-13	00363036713	1 BOTTLE, PLASTIC in 1 CARTON (0363-0367-13) / 250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC		2000-06-10	0000-00-00	No	No	Current
0363-0367-91	00363036791	1 BOTTLE in 1 CARTON (0363-0367-91) > 125 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2000-06-10	2021-10-02	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nighttime Sleep Aid	Walgreen Company \| LNK International, Inc.	2026-05-13	HUMAN OTC DRUG LABEL	19