Dimenhydrinate

Product NDC: 0904-6772
11-digit product format: 009046772
Labeler code: 0904
Product ID: 0904-6772_3c44729b-0a55-8eaf-e063-6394a90a5ba4
Type: HUMAN OTC DRUG
Nonproprietary name: Dimenhydrinate
Dosage form: TABLET
Route: ORAL
Labeler: Major Pharmaceuticals
Application: M009
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-02-14
Marketing end: 2028-08-31
Substance: DIMENHYDRINATE
Active strength: 50 mg/1
NDC exclude flag: No
Current FDA listing: Yes

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: Dimenhydrinate

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIMENHYDRINATE	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
JB937PER5C	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198603	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
78d22836-a442-7c0c-e053-2991aa0a62f3	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0904-6772-12	Dimenhydrinate	12 in 1 BLISTER PACK	TABLET	12		4
0904-6772-12	Dimenhydrinate	1 in 1 CARTON	TABLET	1		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6772-12	EA - Each	0904-6772	d09bf812-9a2f-4a7e-bfcd-054e62f3ffd7	1	2019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-6772	DIMENHYDRINATE TABLET [MAJOR PHARMACEUTICALS]	3	Current NDC, Legacy NDC, 2 package rows	20240507_78d22836-a442-7c0c-e053-2991aa0a62f3.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 6 · 107 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Airmit Ace	DIMENHYDRINATE	Sato Pharmaceutical Co., Ltd.	a98d252d-4cfa-496a-ab2c-627f45f0d7d9	2023-12-01	Warnings	Exact identifier application number: M009
Meclizine HCl	MECLIZINE HYDROCHLORIDE	BluePoint Laboratories	d9cae5a6-8d4b-bdaf-e053-2995a90a7d44	2023-11-17	Warnings	Exact identifier application number: M009
ZenTrip Motion Sickness	MECLIZINE HYDROCHLORIDE	Sato Pharmaceutical Co., LTD	bd86c4c7-b6f0-e3e8-e053-2995a90a4454	2023-11-03	Warnings	Exact identifier application number: M009
Travel-Ease	MECLIZINE HCL	Geri-Care Pharmaceutical Corp	e3c64eb9-4972-29d9-e053-2a95a90a2a8a	2023-10-25	Warnings	Exact identifier application number: M009
Gravol	DIMENHYDRINATE	Church & Dwight Co., Inc.	d95240bb-02f2-3226-e053-2995a90afacd	2022-03-03	Warnings	Exact identifier application number: M009
Allergy DyeFree	ALLERGY DYEFREE	Allegiant Health	15736bb8-5a5b-489d-83ad-4cf34ec62956	2021-04-26	Warnings	Exact identifier application number: M009
Motion Sickness Relief	DIMENHYDRINATE 50MG	Allegiant Health	7b0aa993-f08f-4dff-a82d-f35b3ebe3cc1	2019-12-12	Warnings	Exact identifier application number: M009

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JB937PER5C	DIMENHYDRINATE	523-87-5	DIMENHYDRINATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198603	dimenhyDRINATE 50 MG Oral Tablet	PSN	78d22836-a442-7c0c-e053-2991aa0a62f3	4
198603	dimenhydrinate 50 MG Oral Tablet	SCD	78d22836-a442-7c0c-e053-2991aa0a62f3	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-6772-12	00904677212	1 BLISTER PACK in 1 CARTON (0904-6772-12) / 12 TABLET in 1 BLISTER PACK	1 blister pack	2019-02-14	2028-08-31	No	No	Current