DORMMY-LON

Product NDC: 83164-000
11-digit product format: 831640000
Labeler code: 83164
Product ID: 83164-000_4960ab74-45e1-6df7-e063-6394a90ac2d9
Type: HUMAN OTC DRUG
Nonproprietary name: DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: Haendel Farma, S.A. de C.V.
Application: M010
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-01-04
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

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 · 22 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 package	package	83164-000-01	`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 package	package	83164-000-01	`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 package	package	83164-000-01	`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 package	package	83164-000-01	`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 package	package	83164-000-01	`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 package	package	83164-000-01	`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 package	package	83164-000-01	`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 package	package	83164-000-01	`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 package	package	83164-000-01	`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 package	package	83164-000-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	83164-000-01	`367a005e9d99…`	`383a685ebd0f…`

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: DORMMY-LON
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 · 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
562db961-83cb-4b74-9f34-fecee2c1be17	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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
83164-000-01	2024-07-30	C162847	48780-1	1030e365-1b4b-111a-e063-dadaa90a10e2	DORMMY-LON
83164-000-01	2024-01-30	C162847	48780-1	1030e365-1b4b-111a-e063-dadaa90a10e2	DORMMY-LON

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
83164-000-01	DORMMY-LON	60 in 1 BOTTLE	TABLET	60		3
83164-000-01	DORMMY-LON	1 in 1 BOX	TABLET	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83164-000	DORMMY-LON (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET [HAENDEL FARMA, S.A. DE C.V.]	2	Current NDC, 2 package rows	20230124_562db961-83cb-4b74-9f34-fecee2c1be17.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 12 · 236 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	TOP CARE (Topco Associates LLC)	027d7eff-6c83-40f1-9716-231637cdbeba	2025-06-12	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid maximum strength	DIPHENHYDRAMINE HCL	Cardinal Health (Leader) 70000	546e4fda-6eb2-4358-840e-e2473bf7f352	2025-06-03	Warnings	Exact identifier application number: M010
Simply Sleep	DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	37c606b0-04d5-49f0-886a-3ee2c9b0e9cc	2025-06-02	Warnings	Exact identifier application number: M010
Sleep Aid Maximum Strength	DIPHENHYDRAMINE HCL	WinCo Foods, LLC	e9bc5a16-b1fc-4585-8f3b-30ccf4300492	2025-05-30	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	Care One (Retail Business Services, LLC.)	51e633a8-5bfc-4ff9-816f-3bc22b8a5c4c	2025-05-23	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid Maximum Strength	DIPHENHYDRAMINE HCL	Care One (Retail Business Services, LLC.)	536cd7d6-a470-4614-89c8-6c3ada582a90	2025-05-23	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	Cardinal Health (Leader) 70000	133d6f38-9de7-4104-8175-3933b263afe0	2025-05-16	Warnings	Exact identifier application number: M010
Nighttime Sleep-aid	DIPHENHYDRAMINE HCL	NORTHEAST PHARMA	d2062094-d1b5-38ab-e053-2995a90a5670	2025-05-15	Warnings	Exact identifier application number: M010
Nighttime Sleep-aid	DIPHENHYDRAMINE HCL	Geri-Care Pharmaceutical Corp	0fce381f-28ef-4591-a569-c5d599a3b95f	2025-05-14	Warnings	Exact identifier application number: M010
Rest Simply	DIPHENHYDRAMINE HYDROCHLORIDE	Chain Drug Marketing Association	54bdb6bc-622c-412a-8365-a1b1c968e13e	2025-05-01	Warnings	Exact identifier application number: M010
Sleep Aid Nighttime	DIPHENHYDRAMINE HCL	United Natural Foods, Inc. dba UNFI	217a211e-b8bf-4119-a094-0e5e733d0b18	2025-04-21	Warnings	Exact identifier application number: M010
Sleep Aid	DIPHENHYDRAMINE HCL	QUALITY CHOICE (Chain Drug Marketing Association)	25f32a1c-0687-45e9-8142-96cf63599090	2025-04-03	Warnings	Exact identifier application number: M010
Sleep Aid	DIPHENHYDRAMINE HCL	FSA Store Inc. (Caring Mills)	9d32a3a1-9528-4de4-9fd1-1d01a1ad93e9	2025-03-28	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HCL	WR Group, Inc.	d28d0f6d-8029-4e31-b417-4f8f864d840e	2025-03-28	Warnings	Exact identifier application number: M010
Sleep Aid NightTime	DIPHENHYDRAMINE HCL	P & L Development, LLC	4144b1a6-aeae-4560-a997-b07206d80350	2025-03-24	Warnings	Exact identifier application number: M010
Sleep Aid	DIPHENHYDRAMINE HCL	Strategic Sourcing Services LLC	a512413c-639b-4846-b016-332a78b50ab7	2025-03-21	Warnings	Exact identifier application number: M010
Diphenhydramine HCl	DIPHENHYDRAMINE HCL	PD-Rx Pharmaceuticals, Inc.	1ee41c86-6767-43ca-a5bb-fc685fa662cd	2025-03-20	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	562db961-83cb-4b74-9f34-fecee2c1be17	3
1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	562db961-83cb-4b74-9f34-fecee2c1be17	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
83164-000-01	83164000001	1 BOTTLE in 1 BOX (83164-000-01) / 60 TABLET in 1 BOTTLE	1 bottle	2023-01-04	No	No	Current