FDA.reportPublic FDA data

Dramamine for Kids

Product NDC
63029-904
11-digit product format
630290904
Labeler code
63029
Product ID
63029-904_5bdaae92-e9c3-401c-a31c-5d0218b0481f
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
2012-02-15
Marketing end
2028-05-01
Substance
DIMENHYDRINATE
Active strength
25 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dramamine for Kids

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMENHYDRINATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJB937PER5C
Rxcui1245184, 1245186

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63029-904-012025-09-09C16284748780-19d75b9d0-3b32-f424-e053-dadaa90a57ceDramamine for Kids
63029-904-012020-01-31C16284748780-19d75b9d0-3b32-f424-e053-dadaa90a57ceDramamine for Kids

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63029-904-01Dramamine for Kids1 in 1 BLISTER PACKTABLET, CHEWABLE14
63029-904-01Dramamine for Kids8 in 1 CASETABLET, CHEWABLE84

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63029-904-01EA - Each63029-904216a5c51-e4ee-4248-bf9f-63116c03596812022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMENHYDRINATEACTIVE INGREDIENTJB937PER5CDRAMAMINE FOR KIDS (DIMENHYDRINATE) TABLET, CHEWABLE [MEDTECH PRODUCTS INC.]3
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MDRAMAMINE FOR KIDS (DIMENHYDRINATE) TABLET, CHEWABLE [MEDTECH PRODUCTS INC.]3
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1DRAMAMINE FOR KIDS (DIMENHYDRINATE) TABLET, CHEWABLE [MEDTECH PRODUCTS INC.]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPDRAMAMINE FOR KIDS (DIMENHYDRINATE) TABLET, CHEWABLE [MEDTECH PRODUCTS INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DRAMAMINE FOR KIDS (DIMENHYDRINATE) TABLET, CHEWABLE [MEDTECH PRODUCTS INC.]3
SORBITOLINACTIVE INGREDIENT506T60A25RDRAMAMINE FOR KIDS (DIMENHYDRINATE) TABLET, CHEWABLE [MEDTECH PRODUCTS INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63029-904DRAMAMINE FOR KIDS (DIMENHYDRINATE) TABLET, CHEWABLE [MEDTECH PRODUCTS INC.]3Current NDC, Legacy NDC, 2 package rows20121026_12bc3f17-ed62-4d0d-9b1e-3835579e711b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1245184dimenhyDRINATE 25 MG Chewable TabletPSN12bc3f17-ed62-4d0d-9b1e-3835579e711b4
1245186Dramamine 25 MG Chewable TabletPSN12bc3f17-ed62-4d0d-9b1e-3835579e711b4
1245186dimenhydrinate 25 MG Chewable Tablet [Dramamine]SBD12bc3f17-ed62-4d0d-9b1e-3835579e711b4
1245184dimenhydrinate 25 MG Chewable TabletSCD12bc3f17-ed62-4d0d-9b1e-3835579e711b4
1245186Dramamine 25 MG Chewable TabletSY12bc3f17-ed62-4d0d-9b1e-3835579e711b4
1245186Dramamine for Kids 25 MG Chewable TabletSY12bc3f17-ed62-4d0d-9b1e-3835579e711b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63029-904-01630290904011 CASE in 1 BLISTER PACK (63029-904-01) / 8 TABLET, CHEWABLE in 1 CASE1 case2012-02-152028-05-01NoNoHistorical