FDA.reportPublic FDA data

Gravol

Product NDC
10237-941
11-digit product format
102370941
Labeler code
10237
Product ID
10237-941_ff55ed07-d94e-467a-b8cf-f7a00ecdae4c
Type
HUMAN OTC DRUG
Nonproprietary name
Dimenhydrinate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Church & Dwight Co., Inc.
Application
M009
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-03-02
Substance
DIMENHYDRINATE
Active strength
50 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
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
Gravol
Listing expiration
2026-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198603Internal RxNorm lookup
2594774Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d95240bb-02f2-3226-e053-2995a90afacdAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10237-941-10Gravol10 in 1 BLISTER PACKTABLET, COATED103
10237-941-10Gravol1 in 1 CARTONTABLET, COATED13
10237-941-30Gravol3 in 1 CARTONTABLET, COATED33
10237-941-30Gravol10 in 1 BLISTER PACKTABLET, COATED103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-941GRAVOL (DIMENHYDRINATE) TABLET, COATED [CHURCH & DWIGHT CO., INC.]3Current NDC, Legacy NDC, 4 package rows20240517_d95240bb-02f2-3226-e053-2995a90afacd.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 · 112 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DRAMAMINE CHEWABLE ORANGEMECLIZINE HYDROCHLORIDEMedtech Products Inc.30387e63-278d-412a-bcad-7965c7c0aea72026-06-23WarningsExact identifier
application number: M009
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 ReliefDIMENHYDRINATEAmerisource Bergenc4077301-db6c-473d-beb3-232d7134a13a2026-06-03WarningsExact 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198603dimenhyDRINATE 50 MG Oral TabletPSNd95240bb-02f2-3226-e053-2995a90afacd3
2594774Gravol 50 MG Oral TabletPSNd95240bb-02f2-3226-e053-2995a90afacd3
2594774dimenhydrinate 50 MG Oral Tablet [Gravol]SBDd95240bb-02f2-3226-e053-2995a90afacd3
198603dimenhydrinate 50 MG Oral TabletSCDd95240bb-02f2-3226-e053-2995a90afacd3
2594774Gravol 50 MG Oral TabletSYd95240bb-02f2-3226-e053-2995a90afacd3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10237-941-10102370941101 BLISTER PACK in 1 CARTON (10237-941-10) / 10 TABLET, COATED in 1 BLISTER PACK1 blister pack2022-03-020000-00-00NoNoCurrent
10237-941-30102370941303 BLISTER PACK in 1 CARTON (10237-941-30) / 10 TABLET, COATED in 1 BLISTER PACK3 blister pack2024-05-15NoNoCurrent