FDA.reportPublic FDA data

Gravol

Product NDC
10237-940
11-digit product format
102370940
Labeler code
10237
Product ID
10237-940_0f7eb768-a541-4459-86a5-45cb451cfb33
Type
HUMAN OTC DRUG
Nonproprietary name
Dimenhydrinate
Dosage form
CAPSULE, LIQUID FILLED
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
309912Internal RxNorm lookup
2594772Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d941705f-12a1-4757-e053-2995a90ad3faAvailable 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
10237-940-08Gravol1 in 1 CARTONCAPSULE, LIQUID FILLED14
10237-940-08Gravol8 in 1 BLISTER PACKCAPSULE, LIQUID FILLED84
10237-940-24Gravol8 in 1 BLISTER PACKCAPSULE, LIQUID FILLED84
10237-940-24Gravol3 in 1 CARTONCAPSULE, LIQUID FILLED34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10237-940GRAVOL (DIMENHYDRINATE) CAPSULE, LIQUID FILLED [CHURCH & DWIGHT CO., INC.]4Current NDC, Legacy NDC, 4 package rows20240524_d941705f-12a1-4757-e053-2995a90ad3fa.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
ndc (product): 10237-940
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
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
309912dimenhyDRINATE 50 MG Oral CapsulePSNd941705f-12a1-4757-e053-2995a90ad3fa4
2594772Gravol 50 MG Oral CapsulePSNd941705f-12a1-4757-e053-2995a90ad3fa4
2594772dimenhydrinate 50 MG Oral Capsule [Gravol]SBDd941705f-12a1-4757-e053-2995a90ad3fa4
309912dimenhydrinate 50 MG Oral CapsuleSCDd941705f-12a1-4757-e053-2995a90ad3fa4
2594772Gravol 50 MG Oral CapsuleSYd941705f-12a1-4757-e053-2995a90ad3fa4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10237-940-08102370940081 BLISTER PACK in 1 CARTON (10237-940-08) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2022-03-020000-00-00NoNoCurrent
10237-940-24102370940243 BLISTER PACK in 1 CARTON (10237-940-24) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK3 blister pack2024-05-15NoNoCurrent