Diphenhydramine HCl 25mg

Product NDC: 69168-002
11-digit product format: 691680002
Labeler code: 69168
Product ID: 69168-002_36c028e5-005a-42eb-958c-9fed406827b3
Type: HUMAN OTC DRUG
Nonproprietary name: Sleep Aid
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Allegiant Health
Application: M010
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-11-23
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: Diphenhydramine HCl 25mg
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 · 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
2890e4ba-d642-437d-8a86-24996a74e027	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	Strength	SPL version
69168-002-93	Diphenhydramine HCl 25mg	24 in 1 CARTON	TABLET, COATED	24		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69168-002	DIPHENHYDRAMINE HCL 25MG (SLEEP AID) TABLET, COATED [ALLEGIANT HEALTH]	4	Current NDC, Legacy NDC, 1 package rows	20231020_2890e4ba-d642-437d-8a86-24996a74e027.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 10 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	CVS Pharmacy, Inc.	6e0f7ab7-eb1e-9a19-e053-2991aa0a6d1f	2024-12-02	Warnings	Exact identifier application number: M010
Diphenhydramine HCl	DIPHENHYDRAMINE HCL	CVS Pharmacy, Inc.	6dd802ec-fc26-3913-e053-2a91aa0ad05d	2024-12-02	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	PUBLIX SUPER MARKETS INC	236ff457-0ec1-9c49-e063-6394a90a707a	2024-11-26	Warnings	Exact identifier application number: M010
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	50d74111-6d1b-4681-a264-f7e550320259	2024-11-25	Warnings	Exact identifier application number: M010
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	efb05387-72c0-4643-8541-b7990c202ce6	2024-11-25	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid, 24-7 Life BY 7-ELEVEN, 6oz	DIPHENHYDRAMINE HCL SOLUTION	Lil' Drug Store Products, Inc.	2781fc28-8a7d-d0fa-e063-6394a90ac793	2024-11-22	Warnings	Exact identifier application number: M010
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	7830ce18-908a-4f86-a238-8c31cfe47ce6	2024-11-21	Warnings	Exact identifier application number: M010
DIPHENHYDRAMINE HYDROCHLORIDE	DIPHENHYDRAMINE HYDROCHLORIDE	Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.	f8de6605-4a0a-492d-beb5-f414ce8bfb0e	2024-11-20	Warnings	Exact identifier application number: M010
Nighttime SLEEP AID	DIPHENHYDRAMINE HCL 50MG	PuraCap Pharmaceutical LLC	272a7138-2a97-8e62-e063-6394a90a1af1	2024-11-18	Warnings	Exact identifier application number: M010
ZzzQuil	DIPHENHYDRAMINE HYDROCHLORIDE	Lil' Drug Store Products, Inc.	0b2777be-85d4-443d-b65f-6750e0ba97ba	2024-11-18	Warnings	Exact identifier application number: M010
RiteAid Nighttime Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE AND ACETAMINOPHEN	RITE AID CORPORATION	54fc0893-9702-4849-a702-3e84dc9ead03	2024-10-30	Warnings	Exact identifier application number: M010
Rite Aid Nighttime Sleep Aid Non Habit Forming	DIPHENHYDRAMINE HYDROCHLORIDE	RITE AID CORPORATION	59ba6824-fa6c-4b3f-9f1f-ea194766c8a1	2024-10-30	Warnings	Exact identifier application number: M010
GOOD REMEDIES Nighttime Sleep Aid Caplets	DIPHENHYDRAMINE HYDROCHLORIDE	Strive Pharmaceuticals Inc.	24fba735-cedf-9d15-e063-6394a90af873	2024-10-29	Warnings	Exact identifier application number: M010
Premier Value Nighttime Sleep-Aid Liquid Sleep-Aid	DIPHENHYDRAMINE HYDROCHLORIDE	Chain Drug Consortium	6d24b6e1-7959-47c6-a09b-c7e00a437495	2024-10-28	Warnings	Exact identifier application number: M010
Nytol	DIPHENHYDRAMINE HCL	Medtech Products Inc.	c81d018a-0170-4396-81e9-2e13a53f868a	2024-10-25	Warnings	Exact identifier application number: M010
Rest Simply	DIPHENHYDRAMINE HYDROCHLORIDE	Marc Glassman, Inc.	2ab3852d-53a4-411b-a9ad-3ef88ab3ee87	2024-10-23	Warnings	Exact identifier application number: M010
nitetime sleep aid	DIPHENHYDRAMINE HCL	Meijer Distribution Inc	43184abd-2525-402a-a388-85af2e5c13ad	2024-10-17	Warnings	Exact identifier application number: M010
Good Sense Sleep Time	DIPHENHYDRAMINE HCL	L. Perrigo Company	164200a9-b1f8-44c9-8598-a7dff5020e9d	2024-10-16	Warnings	Exact identifier application number: M010
Equaline Night Time Sleep Aid	DIPHENHYDRAMINE HCL	United Natural Foods, Inc. dba UNFI	6d34ee3e-3d61-481e-98d6-acfa066e4247	2024-10-16	Warnings	Exact identifier application number: M010
basic care nighttime sleep aid	DIPHENHYDRAMINE HCL	Amazon.com Services LLC	027de5ea-5c07-4960-8a98-8cf2c0e54a92	2024-10-16	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	2890e4ba-d642-437d-8a86-24996a74e027	4
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	2890e4ba-d642-437d-8a86-24996a74e027	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69168-002-93	69168000293	24 TABLET, COATED in 1 CARTON (69168-002-93)	2021-11-23	0000-00-00	No	No	Current