FDA.reportPublic FDA data

Gravol Chewables Motion Sickness Dimenhydrinate

Product NDC
10237-943
11-digit product format
102370943
Labeler code
10237
Product ID
10237-943_a9e0cd6a-8998-4833-ada9-588ef9719542
Type
HUMAN OTC DRUG
Nonproprietary name
Dimenhydrinate
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Church & Dwight Co., Inc.
Application
M009
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-01
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 Chewables Motion Sickness Dimenhydrinate
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
309913Internal RxNorm lookup
2678106Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
de5249f7-79fc-4f3c-965a-1e8ec978a0b7Available 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
10237-943-08Gravol Chewables Motion Sickness Dimenhydrinate1 in 1 CARTONTABLET, CHEWABLE11
10237-943-08Gravol Chewables Motion Sickness Dimenhydrinate8 in 1 BLISTER PACKTABLET, CHEWABLE81

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-943GRAVOL CHEWABLES MOTION SICKNESS DIMENHYDRINATE (DIMENHYDRINATE) TABLET, CHEWABLE [CHURCH & DWIGHT CO., INC.]1Current NDC, 2 package rows20240402_de5249f7-79fc-4f3c-965a-1e8ec978a0b7.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 · 112 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GravolDIMENHYDRINATEChurch & Dwight Co., Inc.d941705f-12a1-4757-e053-2995a90ad3fa2024-05-13WarningsExact identifier
application number: M009
Kids Gravol Chewables Motion Sickness DimenhydrinateDIMENHYDRINATEChurch & Dwight Co., Inc.cf6de950-a157-4be2-a302-0dc19511d2f22024-03-01WarningsExact identifier
application number: M009
Gravol Chewables Motion Sickness DimenhydrinateDIMENHYDRINATEChurch & Dwight Co., Inc.de5249f7-79fc-4f3c-965a-1e8ec978a0b72024-03-01WarningsExact identifier
application number: M009
ndc (product): 10237-943
Meclizine HClMECLIZINE HYDROCHLORIDE CHEWABLEBluePoint Laboratoriesd9cc2705-9dcc-0a73-e053-2995a90aafe62024-02-21WarningsExact identifier
application number: M009
Childrens AllergyDIPHENHYDRAMINE HYDROCHLORIDEDeMoulas Market Basketfd04fb94-f581-4ca2-b7ac-20359093863e2023-12-29WarningsExact identifier
application number: M009
Airmit AceDIMENHYDRINATESato Pharmaceutical Co., Ltd.a98d252d-4cfa-496a-ab2c-627f45f0d7d92023-12-01WarningsExact identifier
application number: M009
Meclizine HClMECLIZINE HYDROCHLORIDEBluePoint Laboratoriesd9cae5a6-8d4b-bdaf-e053-2995a90a7d442023-11-17WarningsExact identifier
application number: M009
ZenTrip Motion SicknessMECLIZINE HYDROCHLORIDESato Pharmaceutical Co., LTDbd86c4c7-b6f0-e3e8-e053-2995a90a44542023-11-03WarningsExact identifier
application number: M009
Travel-EaseMECLIZINE HCLGeri-Care Pharmaceutical Corpe3c64eb9-4972-29d9-e053-2a95a90a2a8a2023-10-25WarningsExact identifier
application number: M009
GravolDIMENHYDRINATEChurch & Dwight Co., Inc.d95240bb-02f2-3226-e053-2995a90afacd2022-03-03WarningsExact identifier
application number: M009
Allergy DyeFreeALLERGY DYEFREEAllegiant Health15736bb8-5a5b-489d-83ad-4cf34ec629562021-04-26WarningsExact identifier
application number: M009
Motion Sickness ReliefDIMENHYDRINATE 50MGAllegiant Health7b0aa993-f08f-4dff-a82d-f35b3ebe3cc12019-12-12WarningsExact identifier
application number: M009

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309913dimenhyDRINATE 50 MG Chewable TabletPSNde5249f7-79fc-4f3c-965a-1e8ec978a0b71
2678106Gravol 50 MG Chewable TabletPSNde5249f7-79fc-4f3c-965a-1e8ec978a0b71
2678106dimenhydrinate 50 MG Chewable Tablet [Gravol]SBDde5249f7-79fc-4f3c-965a-1e8ec978a0b71
309913dimenhydrinate 50 MG Chewable TabletSCDde5249f7-79fc-4f3c-965a-1e8ec978a0b71
2678106Gravol 50 MG Chewable TabletSYde5249f7-79fc-4f3c-965a-1e8ec978a0b71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10237-943-08102370943081 BLISTER PACK in 1 CARTON (10237-943-08) / 8 TABLET, CHEWABLE in 1 BLISTER PACK1 blister pack2024-04-01NoNoCurrent