Sleep Aid

Product NDC: 72090-020
11-digit product format: 720900020
Labeler code: 72090
Product ID: 72090-020_29ee011c-3b29-40a2-8b9b-ff1f5cb2fb69
Type: HUMAN OTC DRUG
Nonproprietary name: Diphenhydramine HCl 25 mg
Dosage form: TABLET
Route: ORAL
Labeler: Pioneer Life Sciences, LLC
Application: M010
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-06-29
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

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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	72090-020		I	Inactivated by FDA	2026-10-05
excluded product	product	72090-020		I	Inactivated by FDA	2026-10-05
excluded product	product	72090-020		I	Inactivated by FDA	2026-10-05
excluded package	package	72090-020	72090-020-24	I	Inactivated by FDA	2026-10-05
excluded package	package	72090-020	72090-020-26	I	Inactivated by FDA	2026-10-05
excluded package	package	72090-020	72090-020-25	I	Inactivated by FDA	2026-10-05

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 2 · 116 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	72090-020-26	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	72090-020-24	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	72090-020-25	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	72090-020-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	72090-020-24	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	72090-020-25	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	72090-020-26	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	72090-020-24	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	72090-020-25	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	72090-020-26	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	72090-020-24	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	72090-020-25	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	72090-020-26	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	72090-020-24	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	72090-020-25	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	72090-020-26	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	72090-020-24	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	72090-020-25	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	72090-020-26	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	72090-020-24	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	72090-020-25	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72090-020-26	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72090-020-24	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72090-020-25	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72090-020-26	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72090-020-24	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72090-020-25	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	72090-020-26	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	72090-020-24	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	72090-020-25	`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: 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 · 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
a9678fed-bda5-9513-e053-2995a90a25a1	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDC	Effective	Indexing SPL	Related label
72090-020-10	2023-10-25	d6a99b39-8fd3-a426-e053-dadaa90af4c2	Nighttime Sleep Aid
72090-020-10	2022-01-28	d6a99b39-8fd3-a426-e053-dadaa90af4c2	Nighttime Sleep Aid
72090-020-24	2022-01-28	d6a99b39-75e6-a426-e053-dadaa90af4c2	a9637ec7-9a71-4023-e053-2995a90ad0da
72090-020-26	2022-01-28	d6a99b39-9027-a426-e053-dadaa90af4c2	aa2ce06b-89bc-b998-e053-2995a90a834a
72090-020-25	2021-01-29	ba0f9c33-24e2-a910-e053-dadaa90a0b85	Diphenhydramine HCl 25 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
72090-020-10	Sleep Aid	100 in 1 BOTTLE	TABLET	100	6
72090-020-24	Sleep Aid	24 in 1 BOTTLE	TABLET	24	2
72090-020-25	Sleep Aid	250 in 1 BOTTLE	TABLET	250	1
72090-020-26	Sleep Aid	1 in 1 CARTON	TABLET	1	1
72090-020-26	Sleep Aid	24 in 1 BOTTLE	TABLET	24	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72090-020	SLEEP AID (DIPHENHYDRAMINE HCL 25 MG) TABLET [PIONEER LIFE SCIENCES, LLC]	5	Current NDC, Legacy NDC, 1 package rows	20240515_a9678fed-bda5-9513-e053-2995a90a25a1.zip
72090-020	SLEEP AID (DIPHENHYDRAMINE HCL 25 MG) TABLET [PIONEER LIFE SCIENCES, LLC]	2	Current NDC, Legacy NDC, 1 package rows	20200702_a9637ec7-9a71-4023-e053-2995a90ad0da.zip
72090-020	SLEEP AID (DIPHENHYDRAMINE HCL 25 MG) TABLET [PIONEER LIFE SCIENCES, LLC]	1	Current NDC, Legacy NDC, 1 package rows	20190220_abde2866-8643-424d-9bd6-f967b645eaa2.zip
72090-020	SLEEP AID (DIPHENHYDRAMINE HCL 25 MG) TABLET [PIONEER LIFE SCIENCES, LLC]	1	Current NDC, Legacy NDC, 2 package rows	20200712_aa2ce06b-89bc-b998-e053-2995a90a834a.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 8 of 13 · 259 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
equate NIGHTTIME Sleep-Aid	DIPHENHYDRAMINE HYDROCHLORIDE	WALMART INC.	3d3f2e0c-e141-d49f-e063-6394a90ad0e6	2025-10-21	Warnings	Exact identifier application number: M010
LEADER Nighttime Sleep-Aid	DIPHENHYDRAMINE HYDROCHLORIDE	CARDINAL HEALTH	6fe34d05-84a4-4254-aea6-77b52122ea18	2025-10-14	Warnings	Exact identifier application number: M010
LEADER Nighttime Sleep-Aid	DIPHENHYDRAMINE HYDROCHLORIDE	CARDINAL HEALTH	68c79c47-11bf-4b51-ace0-723cac7a4620	2025-10-14	Warnings	Exact identifier application number: M010
InstaRelief Nighttime Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	DXM Pharmacuetical, Inc.	e0459e71-32dd-4715-b103-bb14db42c5f3	2025-10-06	Warnings	Exact identifier application number: M010
Sleep Aid	DIPHENHYDRAMINE HCL	Family Dollar (FAMILY WELLNESS)	1eb2e4d7-1572-4c0c-888b-342831298cad	2025-10-03	Warnings	Exact identifier application number: M010
Sleep Aid	DIPHENHYDRAMINE HCL	WinCo Foods, LLC	20b8b9a7-cd04-4e8f-b26e-2d01a0871802	2025-09-29	Warnings	Exact identifier application number: M010
AXIV - VroZzz	DIPHENHYDRAMINE HYDROCHLORIDE	Vivunt Pharma LLC	131a60cf-02ec-5a5b-e063-6294a90abd1f	2025-09-17	Warnings	Exact identifier application number: M010
Sleep Aid	DIPHENHYDRAMINE HCL	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	485ce8ae-c2b7-462f-9c08-8594cd121f0c	2025-09-11	Warnings	Exact identifier application number: M010
Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	WALGREENS	35b78063-e717-2ccb-e063-6394a90a18eb	2025-09-04	Warnings	Exact identifier application number: M010
Sleep Aid	DIPHENHYDRAMINE HCL	TARGET Corporation	ded84160-8f6a-4ad1-93be-efbf3a6c3b8f	2025-09-03	Warnings	Exact identifier application number: M010
QUALITY CHOICE NIGHTTIME SLEEP AID	DIPHENHYDRAMINE HYDROCHLORIDE	QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)	3ce00c99-1a9b-41f1-a99a-35e03730dff0	2025-08-23	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	BJWC (Berkley & Jensen / BJ's)	2f476647-5727-3443-e063-6394a90afd3f	2025-08-19	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	BJWC (Berkley & Jensen / BJ's)	2f477706-0ce2-97b0-e063-6294a90a5c8e	2025-08-19	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	NIGHTTIME SLEEP AID	Allegiant Health	407ff0ee-41a3-4dea-95c8-556f664e115e	2025-08-06	Warnings	Exact identifier application number: M010
Sleep Aid Maximum Strength	DIPHENHYDRAMINE HCL	H E B	1069961c-ed3b-471f-a632-81024c37dbd9	2025-08-04	Warnings	Exact identifier application number: M010
TopCare health NIGHTTIME MAXIMUM STRENGTH Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	Topco Associates LLC	2ea0b2cf-f055-11f6-e063-6394a90a5364	2025-08-01	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	Good Sense (Geiss, Destin & Dunn, Inc.)	135482d0-5264-4c81-b43b-8fc931bb02e8	2025-07-30	Warnings	Exact identifier application number: M010
dg health sleep aid	DIPHENHYDRAMINE HCL	Dolgencorp, LLC	4c266acb-49ae-4d04-8602-0df35b22874a	2025-07-10	Warnings	Exact identifier application number: M010
NIGHT TIME SLEEP-AID	DIPHENHYDRAMINE HCL	Advanced Rx LLC	07c69e63-deb1-4607-9f7f-1cf0cd05cc82	2025-07-02	Warnings	Exact identifier application number: M010
Rest Simply	DIPHENHYDRAMINE HYDROCHLORIDE	DISCOUNT DRUG MART	896ae7b8-cb8d-1aaa-e053-2a95a90a4e1a	2025-06-30	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	a9678fed-bda5-9513-e053-2995a90a25a1	6
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	a9678fed-bda5-9513-e053-2995a90a25a1	6
1049630	diphenhydrAMINE HCl 25 MG Oral Tablet	PSN	a9637ec7-9a71-4023-e053-2995a90ad0da	2
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	a9637ec7-9a71-4023-e053-2995a90ad0da	2
1049630	diphenhydrAMINE HCl 25 MG Oral Tablet	PSN	aa2ce06b-89bc-b998-e053-2995a90a834a	1
1049630	diphenhydrAMINE HCl 25 MG Oral Tablet	PSN	abde2866-8643-424d-9bd6-f967b645eaa2	1
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	aa2ce06b-89bc-b998-e053-2995a90a834a	1
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	abde2866-8643-424d-9bd6-f967b645eaa2	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72090-020-10	72090002010	100 TABLET in 1 BOTTLE (72090-020-10)	100 tablet	2020-06-29	0000-00-00	No	No	Current
72090-020-24	72090002024	24 TABLET in 1 BOTTLE (72090-020-24)	24 tablet	2020-06-29	0000-00-00	No	No	Current
72090-020-25	72090002025	250 in 1 BOTTLE						Historical
72090-020-26	72090002026	1 BOTTLE in 1 CARTON (72090-020-26) > 24 TABLET in 1 BOTTLE	1 bottle	2020-06-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nighttime Sleep Aid	Pioneer Life Sciences, LLC	2025-12-29	HUMAN OTC DRUG LABEL	6
Sleep Aid - Pioneer Life Sciences, LLC	Pioneer Life Sciences, LLC	2020-07-11	HUMAN OTC DRUG LABEL	1
Sleep Aid - Pioneer Life Sciences, LLC	Pioneer Life Sciences, LLC	2020-07-01	HUMAN OTC DRUG LABEL	2
Diphenhydramine HCl 25 mg	Pioneer Life Sciences, LLC	2018-07-23	HUMAN OTC DRUG LABEL	1