FDA.reportPublic FDA data

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
IngredientStrength
DIMENHYDRINATE50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
JB937PER5CInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198603Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
78d22836-a442-7c0c-e053-2991aa0a62f3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-6772-12Dimenhydrinate12 in 1 BLISTER PACKTABLET124
0904-6772-12Dimenhydrinate1 in 1 CARTONTABLET14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6772-12EA - Each0904-6772d09bf812-9a2f-4a7e-bfcd-054e62f3ffd712019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6772DIMENHYDRINATE TABLET [MAJOR PHARMACEUTICALS]3Current NDC, Legacy NDC, 2 package rows20240507_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 2 of 6 · 107 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Motion Sickness ReliefDIMENHYDRINATEWal-Mart Stores Incc25a7f2b-0f01-4ec0-8849-f08c23608d1d2026-06-22WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLCardinal Health 110, LLC. DBA Leader69099658-a584-49a9-8a95-de258a697c4f2026-06-16WarningsExact identifier
application number: M009
Motion Sickness ReliefDIMENHYDRINATETopco Associates, LLC503a70db-d564-4ea0-851e-8ff617e707282026-06-16WarningsExact identifier
application number: M009
Motion SicknessMECLIZINE HCLARMY AND AIR FORCE EXCHANGE SERVICE20229ad5-cb28-4667-ab70-97a1102873a22026-06-16WarningsExact identifier
application number: M009
Motion SicknessDIMENHYDRINATEGeiss, Destin & Dunn Inc.fdb683c5-ff7f-4b93-9892-670cf1f29f2a2026-06-15WarningsExact identifier
application number: M009
DimenhydrinateDIMENHYDRINATECVS Pharmacy, Inc.6dfc5cb4-af0c-56c9-e053-2a91aa0a5d562026-06-12WarningsExact identifier
application number: M009
DriminateDIMENHYDRINATEMajor Pharmaceuticalsd2967f78-41ee-4c30-8b47-0757df9f3d912026-06-10WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLWalgreen Company761b7f9d-eaa1-47f0-89d9-c2da0e364a8b2026-05-18WarningsExact identifier
application number: M009
Motion SicknessMECLIZINE HCLStrategic Sourcing Services LLC550b803c-a038-455c-908a-a6244c0952ba2026-05-12WarningsExact identifier
application number: M009
Motion Sickness ReliefDIMENHYDRINATEValu Merchandisers Company56c26102-8d39-458e-b076-3fe67456a4c02026-04-16WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLDOLGENCORP, LLC1616c540-dcd9-46f1-823f-27b67ef488d22026-04-16WarningsExact identifier
application number: M009
Meclizine HCL 12.5 mgMECLIZINE HCL 12.5 MGProficient Rx LP3ffa63f2-ea06-4be0-9f59-162c2a9604fc2026-04-01WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLMeijer Distribution Inc1ac451c4-2467-46d6-bc0d-f6368699d1682026-03-23WarningsExact identifier
application number: M009
Travel easeMECLIZINE HCLChain Drug Marketing Association, Inc.c1345a46-51f4-4a6e-aa55-05d221e328372026-03-10WarningsExact identifier
application number: M009
Motion Sickness ReliefMECLIZINE HCLAmerisource Bergen71654e2b-a4db-4131-8c51-bedb3995784c2026-03-10WarningsExact identifier
application number: M009
Medique Medi-MeclizineMECLIZINE HCLSportpharm LLC95da2a1e-354c-4851-b147-cf6ee52e14e32026-03-03WarningsExact identifier
application number: M009
Motion SicknessDIMENHYDRINATETarget Corporation3fd4a96f-8f69-42bf-b777-6e3a2bfea2752026-03-03WarningsExact identifier
application number: M009
Motion Sickness Relief Less DrowsyMECLIZINE HCLBetter Living Brands, LLCeff22da8-63b2-47b7-8cfc-e8251029ee442026-02-27WarningsExact identifier
application number: M009
DimenhydrinateDIMENHYDRINATELEADER/ Cardinal Health 110, Inc.7c4adbdb-9bce-0c9c-e053-2a91aa0a81072026-02-20WarningsExact identifier
application number: M009
Dramamine Less DrowsyMECLIZINE HYDROCHLORIDENavajo Manufacturing Company Inc.4b203479-ba8d-7237-e063-6294a90ae6cb2026-02-18WarningsExact identifier
application number: M009

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198603dimenhyDRINATE 50 MG Oral TabletPSN78d22836-a442-7c0c-e053-2991aa0a62f34
198603dimenhydrinate 50 MG Oral TabletSCD78d22836-a442-7c0c-e053-2991aa0a62f34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6772-12009046772121 BLISTER PACK in 1 CARTON (0904-6772-12) / 12 TABLET in 1 BLISTER PACK1 blister pack2019-02-142028-08-31NoNoCurrent