FDA.reportPublic FDA data

Dramamine for Kids

Product NDC
63029-908
11-digit product format
630290908
Labeler code
63029
Product ID
63029-908_46890832-3412-4d20-9c1a-0bd639ad618c
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
2025-02-17
Substance
DIMENHYDRINATE
Active strength
25 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
Dramamine for Kids
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMENHYDRINATE25 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
1245184Internal RxNorm lookup
1245186Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3ccd6eb4-ba7e-4a6a-abb9-a6ef3196240cAvailable 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
63029-908-08Dramamine for Kids8 in 1 BLISTER PACKTABLET, CHEWABLE81
63029-908-08Dramamine for Kids1 in 1 BOXTABLET, CHEWABLE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63029-908DRAMAMINE FOR KIDS (DIMENHYDRINATE) TABLET, CHEWABLE [MEDTECH PRODUCTS INC.]1Current NDC, 2 package rows20250221_3ccd6eb4-ba7e-4a6a-abb9-a6ef3196240c.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
1245184dimenhyDRINATE 25 MG Chewable TabletPSN3ccd6eb4-ba7e-4a6a-abb9-a6ef3196240c1
1245186Dramamine 25 MG Chewable TabletPSN3ccd6eb4-ba7e-4a6a-abb9-a6ef3196240c1
1245186dimenhydrinate 25 MG Chewable Tablet [Dramamine]SBD3ccd6eb4-ba7e-4a6a-abb9-a6ef3196240c1
1245184dimenhydrinate 25 MG Chewable TabletSCD3ccd6eb4-ba7e-4a6a-abb9-a6ef3196240c1
1245186Dramamine 25 MG Chewable TabletSY3ccd6eb4-ba7e-4a6a-abb9-a6ef3196240c1
1245186Dramamine for Kids 25 MG Chewable TabletSY3ccd6eb4-ba7e-4a6a-abb9-a6ef3196240c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63029-908-08630290908081 BLISTER PACK in 1 BOX (63029-908-08) / 8 TABLET, CHEWABLE in 1 BLISTER PACK1 blister pack2025-02-17NoNoCurrent