Sleep II

Product NDC: 0363-0189
11-digit product format: 003630189
Labeler code: 0363
Product ID: 0363-0189_f9530ae2-f2e6-4caa-8f2f-4840b31d5ef8
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCl
Dosage form: TABLET
Route: ORAL
Labeler: Walgreen Company
Application: M010
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1990-04-10
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	0363-0189	0363-0189-08	D	Discontinued by firm	2026-10-12
excluded package	package	0363-0189	0363-0189-21	D	Discontinued by firm	2026-10-12
excluded package	package	0363-0189	0363-0189-23	D	Discontinued by firm	2026-10-12

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 · 36 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	0363-0189-21	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	0363-0189-23	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	0363-0189-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	0363-0189-21	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	0363-0189-23	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	0363-0189-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	0363-0189-23	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	0363-0189-21	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	0363-0189-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	0363-0189-23	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	0363-0189-21	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	0363-0189-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	0363-0189-23	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	0363-0189-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	0363-0189-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	0363-0189-23	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	0363-0189-21	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	0363-0189-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	0363-0189-23	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	0363-0189-21	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	0363-0189-08	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	0363-0189-23	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	0363-0189-21	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	0363-0189-08	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	0363-0189-23	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	0363-0189-21	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	0363-0189-08	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	0363-0189-23	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	0363-0189-21	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	0363-0189-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	0363-0189-23	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	0363-0189-21	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	0363-0189-08	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	0363-0189-23	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	0363-0189-21	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	0363-0189-08	`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 II
Brand name suffix: Nighttime Sleep Aid
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
ed864c84-a430-4ca8-87e8-04f1c1df538b	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
0363-0189-08	Sleep IINighttime Sleep Aid	8 in 1 BLISTER PACK	TABLET	8	27
0363-0189-08	Sleep IINighttime Sleep Aid	3 in 1 CARTON	TABLET	3	27
0363-0189-21	Sleep IINighttime Sleep Aid	2 in 1 CARTON	TABLET	2	27
0363-0189-21	Sleep IINighttime Sleep Aid	8 in 1 BLISTER PACK	TABLET	8	27
0363-0189-23	Sleep IINighttime Sleep Aid	1 in 1 CARTON	TABLET	1	27
0363-0189-23	Sleep IINighttime Sleep Aid	72 in 1 BOTTLE, PLASTIC	TABLET	72	27
0363-0189-46	Sleep IINighttime Sleep Aid	1 in 1 CARTON	TABLET	1	27
0363-0189-46	Sleep IINighttime Sleep Aid	96 in 1 BOTTLE, PLASTIC	TABLET	96	27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0363-0189-08	EA - Each	0363-0189	e141d3ae-5829-4cf3-abad-79231269eebc	1	2014-10-03
0363-0189-21	EA - Each	0363-0189	5cb420bd-7349-4038-b375-577cd70a2091	1	2012-07-24
0363-0189-23	EA - Each	0363-0189	d89ac9ee-d733-4a6c-a9f7-49179f9daa7c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	SLEEP II NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET [WALGREEN CO.]	10
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	SLEEP II NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET [WALGREEN CO.]	10
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	SLEEP II NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET [WALGREEN CO.]	10
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SLEEP II NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET [WALGREEN CO.]	10
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SLEEP II NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET [WALGREEN CO.]	10
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	SLEEP II NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET [WALGREEN CO.]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SLEEP II NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET [WALGREEN CO.]	10
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SLEEP II NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET [WALGREEN CO.]	10
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	SLEEP II NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET [WALGREEN CO.]	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-0189	SLEEP II NIGHTTIME SLEEP AID (DIPHENHYDRAMINE HCL) TABLET [WALGREEN COMPANY]	26	Current NDC, Legacy NDC, 8 package rows	20250512_ed864c84-a430-4ca8-87e8-04f1c1df538b.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 5 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED	AMZ789 LLC	12dd2419-b2e0-5466-e063-6394a90a4221	2026-01-07	Warnings	Exact identifier application number: M010
DIPHENHYDRAMINE HYDROCHLORIDE 50mg	DIPHENHYDRAMINE HYDROCHLORIDE 50MG	AMZ789 LLC	af0b1b08-e269-6399-e053-2a95a90ac12d	2026-01-07	Warnings	Exact identifier application number: M010
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	Prodose, Inc.	3b1ea33b-8460-31cf-e063-6394a90a5534	2025-12-31	Warnings	Exact identifier application number: M010
SleepAid Softgels	DIPHENHYDRAMINE HYDROCHLORIDE	PIONEER LIFE SCIENCES, LLC	c1dab616-c3ff-4d0a-be13-e8dc6b1a26cc	2025-12-29	Warnings	Exact identifier application number: M010
Sleep Aid	DIPHENHYDRAMINE HCL 25 MG	Pioneer Life Sciences, LLC	a9678fed-bda5-9513-e053-2995a90a25a1	2025-12-29	Warnings	Exact identifier application number: M010
sleep patches	SLEEP PATCHES	Changsha Maocheng Trading Co., Ltd	25eddec9-1713-c2c8-e063-6394a90af02c	2025-12-29	Warnings	Exact identifier application number: M010
SleepAid Softgels	DIPHENHYDRAMINE HYDROCHLORIDE	PIONEER LIFE SCIENCES, LLC	9d6b5ec1-3aa4-4a19-936e-c44b04b2f3fa	2025-12-29	Warnings	Exact identifier application number: M010
Sleep Aid	DIPHENHYDRAMINE HCL	Safeway, Inc.	65d1a199-0a8e-41b1-a767-f16e3f91ac94	2025-12-26	Warnings	Exact identifier application number: M010
Sleep Aid	DIPHENHYDRAMINE HCL	Safeway, Inc.	837ddc3a-a8d4-454f-974c-979732cb0a22	2025-12-26	Warnings	Exact identifier application number: M010
Pharbedryl	DIPHENHYDRAMINE HCL	Pharbest Pharmaceuticals, Inc.	070e556b-e083-452f-8a7c-aca92470dd61	2025-12-24	Warnings	Exact identifier application number: M010
PHARBEDRYL	DIPHENHYDRAMINE HCL	Pharbest Pharmaceuticals, Inc.	a19f1edc-d2cf-45fc-8233-d882441b0247	2025-12-24	Warnings	Exact identifier application number: M010
NIGHT TIME SLEEP-AID	DIPHENHYDRAMINE HCL	Discount Drug Mart	ac1860cb-da95-45bf-9261-19f39c56ddfe	2025-12-23	Warnings	Exact identifier application number: M010
SleepAid Softgels	DIPHENHYDRAMINE HYDROCHLORIDE	NUVICARE LLC	963c6925-dfbf-4cdc-8d13-5e10b499c4a9	2025-12-19	Warnings	Exact identifier application number: M010
Sleep Aid	DIPHENHYDRAMINE HCL 25 MG	NUVICARE LLC	85391744-3bf5-428e-a77b-464aa95b3a1a	2025-12-19	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	VALU MERCHANDISERS COMPANY	70ec6ac1-2fd8-49dd-9ccb-c16e2f09a2b2	2025-12-11	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	VALU MERCHANDISERS COMPANY	d337a0e6-09ed-4db0-8883-ec8a5d56bd35	2025-12-11	Warnings	Exact identifier application number: M010
Topcare ZZZ Sleep	DIPHENHYDRAMINE HCL	Topco Associates LLC	27225d04-6deb-436b-89ea-9842c487292e	2025-12-11	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	HEB	91426a5b-dc01-a27b-e053-2a95a90a8ff8	2025-12-09	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid, 24-7 Life by 7-Eleven	DOXYLAMINE SUCCINATE TABLET	Lil' Drug Store Products, Inc.	457814bc-535c-a136-e063-6394a90af9a4	2025-12-08	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	Shield Pharmaceuticals Corp	97eb3e4d-06b7-49ed-909b-95b523dcce41	2025-12-05	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	ed864c84-a430-4ca8-87e8-04f1c1df538b	27
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	ed864c84-a430-4ca8-87e8-04f1c1df538b	27

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0363-0189-08	00363018908	3 BLISTER PACK in 1 CARTON (0363-0189-08) > 8 TABLET in 1 BLISTER PACK	3 blister pack	1990-04-10	2022-08-14	No	No	Current
0363-0189-21	00363018921	2 in 1 CARTON						Historical
0363-0189-23	00363018923	1 BOTTLE, PLASTIC in 1 CARTON (0363-0189-23) > 72 TABLET in 1 BOTTLE, PLASTIC		1990-04-10	2022-02-13	No	No	Current
0363-0189-46	00363018946	1 BOTTLE, PLASTIC in 1 CARTON (0363-0189-46) / 96 TABLET in 1 BOTTLE, PLASTIC		1990-04-10	0000-00-00	No	No	Current