FDA.reportPublic FDA data

Motion Sickness

Product NDC
11673-198
11-digit product format
116730198
Labeler code
11673
Product ID
11673-198_56ebc3a3-ac58-4b27-8613-a5f6ecefda20
Type
HUMAN OTC DRUG
Nonproprietary name
Dimenhydrinate
Dosage form
TABLET
Route
ORAL
Labeler
Target Corporation
Application
M009
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1992-12-01
Marketing end
2027-10-31
Substance
DIMENHYDRINATE
Active strength
50 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
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
Motion Sickness

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
3fd4a96f-8f69-42bf-b777-6e3a2bfea275Available 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
11673-198-02Motion Sickness6 in 1 BLISTER PACKTABLET617
11673-198-02Motion Sickness2 in 1 CARTONTABLET217
11673-198-08Motion Sickness6 in 1 BLISTER PACKTABLET617
11673-198-08Motion Sickness4 in 1 CARTONTABLET417

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMENHYDRINATEACTIVE INGREDIENTJB937PER5CMOTION SICKNESS (DIMENHYDRINATE) TABLET [TARGET CORPORATION]3
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MMOTION SICKNESS (DIMENHYDRINATE) TABLET [TARGET CORPORATION]3
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JMOTION SICKNESS (DIMENHYDRINATE) TABLET [TARGET CORPORATION]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMOTION SICKNESS (DIMENHYDRINATE) TABLET [TARGET CORPORATION]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MOTION SICKNESS (DIMENHYDRINATE) TABLET [TARGET CORPORATION]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MOTION SICKNESS (DIMENHYDRINATE) TABLET [TARGET CORPORATION]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMOTION SICKNESS (DIMENHYDRINATE) TABLET [TARGET CORPORATION]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-198MOTION SICKNESS (DIMENHYDRINATE) TABLET [TARGET CORPORATION]16Current NDC, Legacy NDC, 4 package rows20250311_3fd4a96f-8f69-42bf-b777-6e3a2bfea275.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
198603dimenhyDRINATE 50 MG Oral TabletPSN3fd4a96f-8f69-42bf-b777-6e3a2bfea27517
198603dimenhydrinate 50 MG Oral TabletSCD3fd4a96f-8f69-42bf-b777-6e3a2bfea27517

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11673-198-02116730198022 BLISTER PACK in 1 CARTON (11673-198-02) / 6 TABLET in 1 BLISTER PACK2 blister pack1992-12-012027-10-31NoNoCurrent
11673-198-08116730198084 BLISTER PACK in 1 CARTON (11673-198-08) / 6 TABLET in 1 BLISTER PACK4 blister pack1992-12-012027-10-31NoNoCurrent