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 3 of 13 · 259 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	Family Dollar Services Inc	2d63400b-43ae-4dd2-b917-3f65e02366b4	2026-06-08	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
Sleep Aid Nighttime	DIPHENHYDRAMINE HCL	Walgreen Company	ec3618dd-8713-4f3c-b639-fc240021c7be	2026-05-13	Warnings	Exact identifier application number: M010
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
VICKS ZzzQuil NIGHTTIME SLEEP-AID	DIPHENHYDRAMINE HCL	The Procter & Gamble Manufacturing Company	05f77c69-c8ea-f8ba-e063-6394a90aa60f	2026-04-23	Warnings	Exact identifier application number: M010
Vicks ZzzQuil Night Pain	DIPHENHYDRAMINE HYDROCHLORIDE AND ACETAMINOPHEN	The Procter & Gamble Manufacturing Company	f3bb75e8-3d43-f91e-e053-2a95a90a584d	2026-04-23	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

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