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 6 of 12 · 236 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Unisom SleepMelts Nighttime Sleep-Aid	DIPHENHYDRAMINE HYDROCHLORIDE	QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)	f50cc038-0973-4c4b-84a7-1c68f41c2410	2025-12-04	Warnings	Exact identifier application number: M010
Walgreens Childrens	NIGHTTIME COUGH	WALGREENS CO.	a270cbe3-bf0a-44da-9359-00e218eba239	2025-12-01	Warnings	Exact identifier application number: M010
ZzzQuil ULTRA, Travel BASIX	DOXYLAMINE SUCCINATE	Lil' Drug Store Products, Inc.	0f8c7219-7b40-27c6-e063-6294a90a27d9	2025-12-01	Warnings	Exact identifier application number: M010
Nighttime Sleep-Aid	DIPHENHYDRAMINE HCL	BIONPHARMA INC.	141b00b7-a283-40ab-e063-6294a90aec77	2025-12-01	Warnings	Exact identifier application number: M010
Nighttime Sleep-Aid	DIPHENHYDRAMINE HCL	BIONPHARMA INC.	1f74e760-9ba9-ac47-e063-6394a90acdff	2025-12-01	Warnings	Exact identifier application number: M010
Nighttime Sleep-Aid	DIPHENHYDRAMINE HCL	DISCOUNT DRUG MART, INC.	116e8192-0c2f-39ed-e063-6294a90abaf3	2025-12-01	Warnings	Exact identifier application number: M010
Nighttime Sleep-Aid	DIPHENHYDRAMINE HCL	AMERISOURCE BERGEN	16b2edd2-c16b-5713-e063-6394a90acf46	2025-12-01	Warnings	Exact identifier application number: M010
Nighttime Sleep-Aid	DIPHENHYDRAMINE HCL	VALU MERCHANDISERS COMPANY	08a38cd2-04ae-1ef9-e063-6294a90a8868	2025-12-01	Warnings	Exact identifier application number: M010
Nighttime Sleep-Aid	DIPHENHYDRAMINE HCL	KROGER COMPANY	0f2c1c6a-29bc-e4a8-e063-6394a90a28cb	2025-12-01	Warnings	Exact identifier application number: M010
Nighttime Sleep-Aid	DIPHENHYDRAMINE HCL	Whole Foods Market, INC.	35acf7d9-e567-996d-e063-6394a90a1cf6	2025-12-01	Warnings	Exact identifier application number: M010
Nighttime Sleep Aid	DIPHENHYDRAMINE HYDROCHLORIDE	WALGREEN COMPANY	048cfa3a-4519-400d-a5ab-ce05c9cc4ec8	2025-11-26	Warnings	Exact identifier application number: M010
Sleep Aid Nighttime	DIPHENHYDRAMINE HCL	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	fe58ce40-ae88-4dc5-9486-e67041f6d852	2025-11-26	Warnings	Exact identifier application number: M010
nighttime sleep aid	DIPHENHYDRAMINE HYDROCHLORIDE	H E B	b72c47a3-cae3-4b98-ae85-e1313b6fd501	2025-11-25	Warnings	Exact identifier application number: M010
Nighttime Wal Flu Severe Cold and Cough	ACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINE	WALGREEN CO.	e88f7777-9987-4e3c-a3d5-3da60f190bfd	2025-11-25	Warnings	Exact identifier application number: M010
Overnight Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL	WALGREENS CO	807e8ace-2901-4c5f-96dc-04c755484b95	2025-11-25	Warnings	Exact identifier application number: M010
Sleep	DIPHENHYDRAMINE HCL	Salado Sales, Inc.	837c02dd-971b-4451-98d8-9c438c9db696	2025-11-24	Warnings	Exact identifier application number: M010
Nighttime SleepAid	DIPHENHYDRAMINE HYDROCHLORIDE	AMERIFOODS TRADING COMPANY	3802d57e-7943-c0c2-e063-6394a90a7580	2025-11-20	Warnings	Exact identifier application number: M010
Sleep-Aid Nighttime	DIPHENHYDRAMINE HCL	CVS PHARMACY	6bd1ad2e-8f47-412d-8620-b149ad90c292	2025-11-17	Warnings	Exact identifier application number: M010
Nighttime Sleep-Aid	DIPHENHYDRAMINE HCL	Rite Aid Corporation	f8d50b4e-735d-4d91-a18d-be3537e46e99	2025-11-15	Warnings	Exact identifier application number: M010
SLEEP AID	DIPHENHYDRAMINE HYDROCHLORIDE	Company name: Topco Associates, LLC	7aec7b1b-39dc-4e99-9f92-d45af0a4a6ec	2025-10-31	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