Unisom SleepMelts Nighttime Sleep-Aid

Product NDC: 63868-393
11-digit product format: 638680393
Labeler code: 63868
Product ID: 63868-393_451d2a55-5219-9ce6-e063-6394a90a2d06
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine Hydrochloride
Dosage form: TABLET, CHEWABLE
Route: ORAL
Labeler: QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)
Application: M010
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-01-07
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: 2026-12-31
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: Unisom SleepMelts Nighttime Sleep-Aid
Listing expiration: 2026-12-31

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
f50cc038-0973-4c4b-84a7-1c68f41c2410	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
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
a90f088a-9578-47a2-8f6e-0a9d32aafec6	Product name	1	20181030
f6c90bdc-1674-455a-aadd-1b1b59e5edeb	Product name	2	20181030
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508
f1ec5c2f-d01e-a277-5826-c7eba86ed99b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63868-393-24	Unisom SleepMelts Nighttime Sleep-Aid	24 in 1 BLISTER PACK	TABLET, CHEWABLE	24		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63868-393	UNISOM SLEEPMELTS NIGHTTIME SLEEP-AID (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, CHEWABLE [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	5	Current NDC, Legacy NDC, 1 package rows	20241220_f50cc038-0973-4c4b-84a7-1c68f41c2410.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
1093098	diphenhydrAMINE HCl 25 MG Disintegrating Oral Tablet	PSN	f50cc038-0973-4c4b-84a7-1c68f41c2410	6
1093102	Unisom SleepMelts 25 MG Disintegrating Oral Tablet	PSN	f50cc038-0973-4c4b-84a7-1c68f41c2410	6
1093102	diphenhydramine hydrochloride 25 MG Disintegrating Oral Tablet [Unisom Sleep]	SBD	f50cc038-0973-4c4b-84a7-1c68f41c2410	6
1093098	diphenhydramine hydrochloride 25 MG Disintegrating Oral Tablet	SCD	f50cc038-0973-4c4b-84a7-1c68f41c2410	6
1093102	Unisom Sleep 25 MG Disintegrating Oral Tablet	SY	f50cc038-0973-4c4b-84a7-1c68f41c2410	6
1093102	Unisom SleepMelts 25 MG Disintegrating Oral Tablet	SY	f50cc038-0973-4c4b-84a7-1c68f41c2410	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63868-393-24	63868039324	24 TABLET, CHEWABLE in 1 BLISTER PACK (63868-393-24)	2019-01-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Unisom Sleep Melts Nighttime Sleep-Aid	QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)	2025-12-04	HUMAN OTC DRUG LABEL	6