Unisom SleepMinis Nighttime Sleep-Aid

Product NDC: 41167-0067
Requested package NDC: 41167-0067-2
11-digit product format: 411670067
Labeler code: 41167
Product ID: 41167-0067_2bf9a980-5845-44ff-aad4-1dbcfd67f6eb
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCl
Dosage form: CAPSULE
Route: ORAL
Labeler: Chattem, Inc.
Application: M010
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-04-01
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	41167-0067	41167-0067-2	D	Discontinued by firm		2026-08-03

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Unisom SleepMinis 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1049909	Internal RxNorm lookup
1648369	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
a9a44c2f-65eb-4a5a-9e72-43652dce57f7	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
41167-0067-0	Unisom SleepMinis Nighttime Sleep-Aid	1 in 1 CARTON	CAPSULE	1	8
41167-0067-0	Unisom SleepMinis Nighttime Sleep-Aid	60 in 1 BOTTLE, PLASTIC	CAPSULE	60	8
41167-0067-2	Unisom SleepMinis Nighttime Sleep-Aid	1 in 1 CARTON	CAPSULE	1	8
41167-0067-2	Unisom SleepMinis Nighttime Sleep-Aid	20 in 1 BOTTLE, PLASTIC	CAPSULE	20	8

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	UNISOM SLEEPMINIS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) CAPSULE [CHATTEM, INC.]	2
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	UNISOM SLEEPMINIS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) CAPSULE [CHATTEM, INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	UNISOM SLEEPMINIS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) CAPSULE [CHATTEM, INC.]	2
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	UNISOM SLEEPMINIS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) CAPSULE [CHATTEM, INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	UNISOM SLEEPMINIS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) CAPSULE [CHATTEM, INC.]	2
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	UNISOM SLEEPMINIS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) CAPSULE [CHATTEM, INC.]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	UNISOM SLEEPMINIS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) CAPSULE [CHATTEM, INC.]	2
POTASSIUM SORBATE	INACTIVE INGREDIENT	1VPU26JZZ4	UNISOM SLEEPMINIS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) CAPSULE [CHATTEM, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	UNISOM SLEEPMINIS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) CAPSULE [CHATTEM, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	UNISOM SLEEPMINIS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) CAPSULE [CHATTEM, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41167-0067	UNISOM SLEEPMINIS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HCL) CAPSULE [CHATTEM, INC.]	7	Current NDC, Legacy NDC, 4 package rows	20231012_a9a44c2f-65eb-4a5a-9e72-43652dce57f7.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 1 of 14 · 263 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Wal Som Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	Walgreens	ff475a69-dbb2-40a9-b7f4-9c7b7e975d19	2026-07-23	Warnings	Exact identifier application number: M010
Sleep Aid	DIPHENHYDRAMINE HCL	TARGET Corporation	336ac29d-db24-44da-a299-5a4793ae8f6a	2026-07-21	Warnings	Exact identifier application number: M010
Best Choice Childrens Allergy Relief Bubblegum flavor	DIPHENHYDRAMINE HCL	BEST CHOICE (VALU MERCHANDISERS COMPANY)	9bf2d698-8394-46c3-b7a9-e99ab6bb88e4	2026-07-17	Warnings	Exact identifier application number: M010
ADWE dye-free childrens allergy	DIPHENHYDRAMINE HYDROCHLORIDE	RARITAN PHARMACEUTICALS INC	ea3a51af-3025-497f-8cd7-e99391b0d06f	2026-07-17	Warnings	Exact identifier application number: M010
nighttime sleep aid	DIPHENHYDRAMINE HCL	Amazon.com Services LLC	a8056e5f-e9d8-4555-9212-bf1fa3c15439	2026-07-16	Warnings	Exact identifier application number: M010
Sleep Aid	DIPHENHYDRAMINE HCL	Amerisource Bergen	147adc14-ca7c-45f5-9925-ea569edbfe96	2026-07-09	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HCL 25 MG	Health Pharma USA LLC	d659f747-9790-8bd6-e053-2995a90ae793	2026-07-07	Warnings	Exact identifier application number: M010
Pharbedryl	DIPHENHYDRAMINE HCL	St. Mary's Medical Park Pharmacy	3ef18965-bafb-cc19-e063-6394a90af17d	2026-06-29	Warnings	Exact identifier application number: M010
CalmCo Sleep Aid	DIPHENHYDRAMINE HCL	CalmCo LLC	552d0e50-a58c-8e47-e063-6394a90a8f7b	2026-06-26	Warnings	Exact identifier application number: M010
Vicks ZzzQuil Night Pain	DIPHENHYDRAMINE HYDROCHLORIDE AND ACETAMINOPHEN	The Procter & Gamble Manufacturing Company	a7cf8e2e-7aac-a1fa-e053-2a95a90a561a	2026-06-26	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	Bi-Mart	1b40e794-089f-4546-8f8d-ba7016cd4e7f	2026-06-22	Warnings	Exact identifier application number: M010
Sleep-Aid	DIPHENHYDRAMINE HCL	Rite Aid Corporation	1a5668df-2bbc-4724-af39-19d30a8920f3	2026-06-22	Warnings	Exact identifier application number: M010
Sleep Aid Night Time	DIPHENHYDRAMINE HCL	DOLGENCORP, LLC	9f1e2e1f-d3e8-4c8a-9e3e-c2ab9e4c79e8	2026-06-16	Warnings	Exact identifier application number: M010
Sleep Aid	DIPHENHYDRAMINE HCL	Topco Associates, LLC	57a81e24-ef0d-4143-b266-71e2d4be7617	2026-06-16	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	CVS Pharmacy	3710254e-6c3c-4044-9694-59703274cd0f	2026-06-15	Warnings	Exact identifier application number: M010
Sleep Aid Nighttime	DIPHENHYDRAMINE HCL	Wal-Mart Stores Inc	cfddfdeb-701f-452d-876d-8003e6fcefe3	2026-06-15	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	Family Dollar Services Inc	2d63400b-43ae-4dd2-b917-3f65e02366b4	2026-06-08	Warnings	Exact identifier application number: M010
Mantra	MANTRA SLEEP AID WILD CHERRY	MOREMED INC.	316d11fe-a173-a1dd-e063-6394a90af499	2026-05-21	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	TOPCO ASSOCIATES LLC	9558cc42-d27d-42af-b0a7-44cad025165d	2026-05-21	Warnings	Exact identifier application number: M010
Sleep Aid NightTime	DIPHENHYDRAMINE HCL	Wal-Mart Stores Inc	dac2a0b9-f851-467b-a39f-3560d42c96e2	2026-05-20	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
1049909	diphenhydrAMINE HCl 25 MG Oral Capsule	PSN	a9a44c2f-65eb-4a5a-9e72-43652dce57f7	8
1648369	Unisom SleepMinis 25 MG Oral Capsule	PSN	a9a44c2f-65eb-4a5a-9e72-43652dce57f7	8
1648369	diphenhydramine hydrochloride 25 MG Oral Capsule [Unisom Sleep]	SBD	a9a44c2f-65eb-4a5a-9e72-43652dce57f7	8
1049909	diphenhydramine hydrochloride 25 MG Oral Capsule	SCD	a9a44c2f-65eb-4a5a-9e72-43652dce57f7	8
1648369	Unisom Sleep 25 MG Oral Capsule	SY	a9a44c2f-65eb-4a5a-9e72-43652dce57f7	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
41167-0067-2	41167006702	1 BOTTLE, PLASTIC in 1 CARTON (41167-0067-2) > 20 CAPSULE in 1 BOTTLE, PLASTIC	2015-04-01	0000-00-00	No	No	Current