FDA.reportPublic FDA data

Dramamine Original Formula

Product NDC
63029-901
11-digit product format
630290901
Labeler code
63029
Product ID
63029-901_23845de1-5d17-4310-83f5-ba7382003922
Type
HUMAN OTC DRUG
Nonproprietary name
Dimenhydrinate
Dosage form
TABLET
Route
ORAL
Labeler
Medtech Products Inc.
Application
M009
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-01-15
Substance
DIMENHYDRINATE
Active strength
50 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
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
Dramamine Original Formula
Listing expiration
2027-12-31

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
201716Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f9302a5a-295a-4501-9332-e3f5eb387362Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63029-901-01Dramamine Original Formula12 in 1 BLISTER PACKTABLET128
63029-901-01Dramamine Original Formula3 in 1 BOXTABLET38
63029-901-02Dramamine Original Formula1 in 1 BOXTABLET18
63029-901-02Dramamine Original Formula12 in 1 BOTTLETABLET128
63029-901-03Dramamine Original Formula2 in 1 POUCHTABLET28
63029-901-03Dramamine Original Formula1 in 1 CARTONTABLET18

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMENHYDRINATEACTIVE INGREDIENTJB937PER5CDRAMAMINE ORIGINAL FORMULA (DIMENHYDRINATE) TABLET [MEDTECH PRODUCTS INC.]3
CHLORTHEOPHYLLINEACTIVE MOIETYGE2UA340FMDRAMAMINE ORIGINAL FORMULA (DIMENHYDRINATE) TABLET [MEDTECH PRODUCTS INC.]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDRAMAMINE ORIGINAL FORMULA (DIMENHYDRINATE) TABLET [MEDTECH PRODUCTS INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDRAMAMINE ORIGINAL FORMULA (DIMENHYDRINATE) TABLET [MEDTECH PRODUCTS INC.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DRAMAMINE ORIGINAL FORMULA (DIMENHYDRINATE) TABLET [MEDTECH PRODUCTS INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DRAMAMINE ORIGINAL FORMULA (DIMENHYDRINATE) TABLET [MEDTECH PRODUCTS INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DRAMAMINE ORIGINAL FORMULA (DIMENHYDRINATE) TABLET [MEDTECH PRODUCTS INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63029-901DRAMAMINE ORIGINAL FORMULA (DIMENHYDRINATE) TABLET [MEDTECH PRODUCTS INC.]7Current NDC, Legacy NDC, 6 package rows20240104_f9302a5a-295a-4501-9332-e3f5eb387362.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 TabletPSNf9302a5a-295a-4501-9332-e3f5eb3873628
201716Dramamine 50 MG Oral TabletPSNf9302a5a-295a-4501-9332-e3f5eb3873628
201716dimenhydrinate 50 MG Oral Tablet [Dramamine]SBDf9302a5a-295a-4501-9332-e3f5eb3873628
198603dimenhydrinate 50 MG Oral TabletSCDf9302a5a-295a-4501-9332-e3f5eb3873628
201716Dramamine 50 MG Oral TabletSYf9302a5a-295a-4501-9332-e3f5eb3873628
198603dimenhyDRINATE 50 MG Oral TabletPSN4139b5bf-2e49-40c3-9f4a-d8e15c044ead3
201716Dramamine 50 MG Oral TabletPSN4139b5bf-2e49-40c3-9f4a-d8e15c044ead3
201716dimenhydrinate 50 MG Oral Tablet [Dramamine]SBD4139b5bf-2e49-40c3-9f4a-d8e15c044ead3
198603dimenhydrinate 50 MG Oral TabletSCD4139b5bf-2e49-40c3-9f4a-d8e15c044ead3
201716Dramamine 50 MG Oral TabletSY4139b5bf-2e49-40c3-9f4a-d8e15c044ead3
198603dimenhyDRINATE 50 MG Oral TabletPSNec76597c-eb6a-4025-9d64-fb79c2daca511
201716Dramamine 50 MG Oral TabletPSNec76597c-eb6a-4025-9d64-fb79c2daca511
201716dimenhydrinate 50 MG Oral Tablet [Dramamine]SBDec76597c-eb6a-4025-9d64-fb79c2daca511
198603dimenhydrinate 50 MG Oral TabletSCDec76597c-eb6a-4025-9d64-fb79c2daca511
201716Dramamine 50 MG Oral TabletSYec76597c-eb6a-4025-9d64-fb79c2daca511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63029-901-01630290901013 BLISTER PACK in 1 BOX (63029-901-01) / 12 TABLET in 1 BLISTER PACK3 blister pack2012-01-150000-00-00NoNoCurrent
63029-901-02630290901021 BOTTLE in 1 BOX (63029-901-02) / 12 TABLET in 1 BOTTLE1 bottle2012-01-150000-00-00NoNoCurrent
63029-901-03630290901031 POUCH in 1 CARTON (63029-901-03) / 2 TABLET in 1 POUCH1 pouch2012-01-150000-00-00NoNoCurrent