FDA.reportPublic FDA data

Dramamine Orange

Product NDC
63029-902
11-digit product format
630290902
Labeler code
63029
Product ID
63029-902_5bb5061c-c75c-0d41-e063-6294a90a2c59
Type
HUMAN OTC DRUG
Nonproprietary name
Dimenhydrinate
Dosage form
TABLET, CHEWABLE
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 Orange
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
309913Internal RxNorm lookup
602223Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
76166156-bce1-492f-833e-6bbd07859c3fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63029-902-01Dramamine Orange1 in 1 BOXTABLET, CHEWABLE16
63029-902-01Dramamine Orange8 in 1 BLISTER PACKTABLET, CHEWABLE86
63029-902-02Dramamine Orange2 in 1 POUCHTABLET, CHEWABLE26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63029-902-01EA - Each63029-90271490ff9-52be-463f-b4e6-50e6aacae5a712022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMENHYDRINATEACTIVE INGREDIENTJB937PER5CDRAMAMINE ORANGE (DIMENHYDRINATE) TABLET, CHEWABLE [MEDTECH PRODUCTS INC.]3
CHLORTHEOPHYLLINEACTIVE MOIETYGE2UA340FMDRAMAMINE ORANGE (DIMENHYDRINATE) TABLET, CHEWABLE [MEDTECH PRODUCTS INC.]3
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933DRAMAMINE ORANGE (DIMENHYDRINATE) TABLET, CHEWABLE [MEDTECH PRODUCTS INC.]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLDRAMAMINE ORANGE (DIMENHYDRINATE) TABLET, CHEWABLE [MEDTECH PRODUCTS INC.]3
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1DRAMAMINE ORANGE (DIMENHYDRINATE) TABLET, CHEWABLE [MEDTECH PRODUCTS INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DRAMAMINE ORANGE (DIMENHYDRINATE) TABLET, CHEWABLE [MEDTECH PRODUCTS INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DRAMAMINE ORANGE (DIMENHYDRINATE) TABLET, CHEWABLE [MEDTECH PRODUCTS INC.]3
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DDRAMAMINE ORANGE (DIMENHYDRINATE) TABLET, CHEWABLE [MEDTECH PRODUCTS INC.]3
SORBITOLINACTIVE INGREDIENT506T60A25RDRAMAMINE ORANGE (DIMENHYDRINATE) TABLET, CHEWABLE [MEDTECH PRODUCTS INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63029-902DRAMAMINE ORANGE (DIMENHYDRINATE) TABLET, CHEWABLE [MEDTECH PRODUCTS INC.]5Current NDC, Legacy NDC, 3 package rows20241116_76166156-bce1-492f-833e-6bbd07859c3f.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
309913dimenhyDRINATE 50 MG Chewable TabletPSN76166156-bce1-492f-833e-6bbd07859c3f6
602223Dramamine 50 MG Chewable TabletPSN76166156-bce1-492f-833e-6bbd07859c3f6
602223dimenhydrinate 50 MG Chewable Tablet [Dramamine]SBD76166156-bce1-492f-833e-6bbd07859c3f6
309913dimenhydrinate 50 MG Chewable TabletSCD76166156-bce1-492f-833e-6bbd07859c3f6
602223Dramamine 50 MG Chewable TabletSY76166156-bce1-492f-833e-6bbd07859c3f6
309913dimenhyDRINATE 50 MG Chewable TabletPSN7a43a0bb-6b0c-440a-9216-9e2eba28a06d1
602223Dramamine 50 MG Chewable TabletPSN7a43a0bb-6b0c-440a-9216-9e2eba28a06d1
602223dimenhydrinate 50 MG Chewable Tablet [Dramamine]SBD7a43a0bb-6b0c-440a-9216-9e2eba28a06d1
309913dimenhydrinate 50 MG Chewable TabletSCD7a43a0bb-6b0c-440a-9216-9e2eba28a06d1
602223Dramamine 50 MG Chewable TabletSY7a43a0bb-6b0c-440a-9216-9e2eba28a06d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63029-902-01630290902011 BLISTER PACK in 1 BOX (63029-902-01) / 8 TABLET, CHEWABLE in 1 BLISTER PACK1 blister pack2012-01-150000-00-00NoNoCurrent
63029-902-02630290902022 TABLET, CHEWABLE in 1 POUCH (63029-902-02) 2012-01-150000-00-00NoNoCurrent
63029-902-04630290902042 POUCH in 1 BOX (63029-902-04) / 2 TABLET, CHEWABLE in 1 POUCH2 pouch2019-09-102028-04-30NoNoCurrent