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 7 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NIGHTTIME SLEEP AID	DIPHENHYDRAMINE HYDROCHLORIDE	WALGREEN COMPANY	e96ec4d4-53b9-4636-a58c-1a5923a021ad	2025-10-31	Warnings	Exact identifier application number: M010
GOODNOW SLEEP AID	DIPHENHYDRAMINE HCL	Gobrands, Inc	7d821b7d-6a31-4ff7-b587-51907ba62658	2025-10-29	Warnings	Exact identifier application number: M010
Sominex	DIPHENHYDRAMINE HYDROCHLORIDE	Medtech Products Inc.	f7858ecf-8498-4465-85d8-3e7814737573	2025-10-23	Warnings	Exact identifier application number: M010
Sominex Max	DIPHENHYDRAMINE HCL	Medtech Products Inc.	e8f6991f-c47a-4d12-934b-04fdf092dac3	2025-10-23	Warnings	Exact identifier application number: M010
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
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

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