Unisom SleepMelts Nighttime Sleep-Aid

Product NDC: 41167-0014
11-digit product format: 411670014
Labeler code: 41167
Product ID: 41167-0014_8cc87722-774c-4126-8c1c-9ff7841a67cd
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine Hydrochloride
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: Chattem, Inc.
Application: M010
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2008-01-01
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	41167-0014	41167-0014-1	D	Discontinued by firm		2026-10-16

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 · 10 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…`

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: Unisom SleepMelts 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
1093098	Internal RxNorm lookup
1093102	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
9105f4f1-7f94-408d-a025-83afb68dc9f0	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
41167-0014-0	Unisom SleepMelts Nighttime Sleep-Aid	3 in 1 CARTON	TABLET, CHEWABLE	3	10
41167-0014-0	Unisom SleepMelts Nighttime Sleep-Aid	8 in 1 BLISTER PACK	TABLET, CHEWABLE	8	10
41167-0014-1	Unisom SleepMelts Nighttime Sleep-Aid	4 in 1 CARTON	TABLET, CHEWABLE	4	10
41167-0014-1	Unisom SleepMelts Nighttime Sleep-Aid	8 in 1 BLISTER PACK	TABLET, CHEWABLE	8	10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIPHENHYDRAMINE HYDROCHLORIDE	ACTIVE INGREDIENT	TC2D6JAD40	UNISOM SLEEPMELTS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, CHEWABLE [CHATTEM, INC.]	4
DIPHENHYDRAMINE	ACTIVE MOIETY	8GTS82S83M	UNISOM SLEEPMELTS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, CHEWABLE [CHATTEM, INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	UNISOM SLEEPMELTS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, CHEWABLE [CHATTEM, INC.]	4
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	UNISOM SLEEPMELTS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, CHEWABLE [CHATTEM, INC.]	4
D&C RED NO. 7	INACTIVE INGREDIENT	ECW0LZ41X8	UNISOM SLEEPMELTS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, CHEWABLE [CHATTEM, INC.]	4
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	UNISOM SLEEPMELTS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, CHEWABLE [CHATTEM, INC.]	4
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	UNISOM SLEEPMELTS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, CHEWABLE [CHATTEM, INC.]	4
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	UNISOM SLEEPMELTS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, CHEWABLE [CHATTEM, INC.]	4
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	UNISOM SLEEPMELTS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, CHEWABLE [CHATTEM, INC.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	UNISOM SLEEPMELTS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, CHEWABLE [CHATTEM, INC.]	4
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	UNISOM SLEEPMELTS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, CHEWABLE [CHATTEM, INC.]	4
SUCROSE	INACTIVE INGREDIENT	C151H8M554	UNISOM SLEEPMELTS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, CHEWABLE [CHATTEM, INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41167-0014	UNISOM SLEEPMELTS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, CHEWABLE [CHATTEM, INC.]	9	Current NDC, Legacy NDC, 4 package rows	20241020_9105f4f1-7f94-408d-a025-83afb68dc9f0.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 3 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	Rite Aid Corporation	fbedb50d-b96f-4ce4-a1dc-d2b357cf6de1	2026-05-13	Warnings	Exact identifier application number: M010
Sleep Aid Nighttime	DIPHENHYDRAMINE HCL	Family Dollar Services Inc	8ebd9949-ef53-4d66-a20c-3e0047b3e1ef	2026-05-13	Warnings	Exact identifier application number: M010
Sleep Aid Nighttime	DIPHENHYDRAMINE HCL	CVS Pharmacy	0be4ef9a-2484-41dd-8bb8-e92d411f1384	2026-05-11	Warnings	Exact identifier application number: M010
Nighttime Sleep-Aid	DIPHENHYDRAMINE HCL	AMERISOURCE BERGEN	ca052b38-de38-7bf0-e053-2995a90a4e85	2026-05-11	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	Strategic Sourcing Services LLC	e68d96c8-21c5-406c-b22c-3e384027c79f	2026-05-07	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	Kroger Company	b71bb567-5605-430b-b3fa-048fe9bbe8ff	2026-05-04	Warnings	Exact identifier application number: M010
Sleep II Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	Walgreen Company	ed864c84-a430-4ca8-87e8-04f1c1df538b	2026-05-04	Warnings	Exact identifier application number: M010
Sleep Aid	DIPHENHYDRAMINE HCL	Walgreen Company	f8f17615-e4ec-49d4-9c0d-581d0fd6feb7	2026-04-28	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	L.N.K. International, Inc.	888dc258-d5a3-4b62-aea1-c81ea29ff6f5	2026-04-28	Warnings	Exact identifier application number: M010
Sleep Aid	DIPHENHYDRAMINE HCL	Amerisource Bergen	8f1cb631-4633-4ef5-868e-48a46ab311a4	2026-04-27	Warnings	Exact identifier application number: M010
Nightime Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	BETTER LIVING BRANDS LLC.	202bb1ff-3273-4872-e063-6294a90abebb	2026-04-11	Warnings	Exact identifier application number: M010
Vicks ZzzQuil Nighttime Sleep-Aid	DIPHENHYDRAMINE HYDROCHLORIDE	The Procter & Gamble Manufacturing Company	1be2f00b-5bdd-82e7-e063-6394a90ab9a5	2026-04-06	Warnings	Exact identifier application number: M010
Night Time Sleep Aid	DIPHENHYDRAMINE HCL	HyVee Inc	cf94fa56-01a5-4d6c-ad08-38b0ea363399	2026-04-03	Warnings	Exact identifier application number: M010
Sleep-Aid	DIPHENHYDRAMINE HCL	ARMY AND AIR FORCE EXCHANGE SERVICE	84ec323d-0523-41e8-856c-e02d6afdc9ec	2026-04-02	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	United Natural Foods, Inc. dba UNFI	6c9b7576-428a-4884-8331-bb312c9046bd	2026-04-01	Warnings	Exact identifier application number: M010
Calmco Sleep Aid	DIPHENHYDRAMINE HCL	CalmCo LLC	471d4c70-813a-19de-e063-6394a90aeb25	2026-03-31	Warnings	Exact identifier application number: M010
Sleep Aid	DIPHENHYDRAMINE HCL	The Kroger Co.	0db543bb-c6c3-4370-a70c-e1652781fd7d	2026-03-25	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HCL 50MG	Grocery Outlet	57a751e9-d8b6-4527-8537-bc4be718f5ec	2026-03-17	Warnings	Exact identifier application number: M010
Sleep Aid	DIPHENHYDRAMINE HCL	Walgreen Company	df7a43d1-83a7-4e86-baef-4b9d1ebf0dbb	2026-03-16	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	Grocery Outlet, Inc.	4454df6a-931f-3f03-e063-6294a90afe73	2026-03-14	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
1093098	diphenhydrAMINE HCl 25 MG Disintegrating Oral Tablet	PSN	9105f4f1-7f94-408d-a025-83afb68dc9f0	10
1093102	Unisom SleepMelts 25 MG Disintegrating Oral Tablet	PSN	9105f4f1-7f94-408d-a025-83afb68dc9f0	10
1093102	diphenhydramine hydrochloride 25 MG Disintegrating Oral Tablet [Unisom Sleep]	SBD	9105f4f1-7f94-408d-a025-83afb68dc9f0	10
1093098	diphenhydramine hydrochloride 25 MG Disintegrating Oral Tablet	SCD	9105f4f1-7f94-408d-a025-83afb68dc9f0	10
1093102	Unisom Sleep 25 MG Disintegrating Oral Tablet	SY	9105f4f1-7f94-408d-a025-83afb68dc9f0	10
1093102	Unisom SleepMelts 25 MG Disintegrating Oral Tablet	SY	9105f4f1-7f94-408d-a025-83afb68dc9f0	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41167-0014-0	41167001400	3 BLISTER PACK in 1 CARTON (41167-0014-0) / 8 TABLET, CHEWABLE in 1 BLISTER PACK	3 blister pack	2008-01-01	0000-00-00	No	No	Current
41167-0014-1	41167001401	4 BLISTER PACK in 1 CARTON (41167-0014-1) > 8 TABLET, CHEWABLE in 1 BLISTER PACK	4 blister pack	2008-01-01	0000-00-00	No	No	Current