FDA.reportPublic FDA data

Dramamine for Kids

Product NDC
63029-910
11-digit product format
630290910
Labeler code
63029
Product ID
63029-910_723c2251-679b-4648-9fbb-a8521db2eb7f
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

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

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
48e2e9ef-4c88-42ef-b825-d1b007475275Available 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
63029-910-01Dramamine for Kids1 in 1 CASETABLET, CHEWABLE14
63029-910-01Dramamine for Kids8 in 1 BLISTER PACKTABLET, CHEWABLE84

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63029-910DRAMAMINE FOR KIDS (DIMENHYDRINATE) TABLET, CHEWABLE [MEDTECH PRODUCTS INC.]4Current NDC, Legacy NDC, 2 package rows20250503_48e2e9ef-4c88-42ef-b825-d1b007475275.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 5 of 6 · 107 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Motion Sickness ReliefDIMENHYDRINATE 50 MGTARGET CORPORATION28586e9b-01e3-0b88-e063-6394a90af7e02025-01-29WarningsExact identifier
application number: M009
MECLIZINEMECLIZINE HCL 12.5MGUlai Health LLCd304e205-85fa-494a-9a68-ae6855b139b12025-01-20WarningsExact identifier
application number: M009
Meclizine HCL 12.5 mgMECLIZINE HCL 12.5 MGReliable 1 Laboratories LLC32832b0f-0b38-27ce-e054-00144ff8d46c2025-01-15WarningsExact identifier
application number: M009
Meclizine HCL 25 mgMECLIZINE HCLReliable 1 Laboratories LLC32bdd802-16b0-184d-e054-00144ff88e882025-01-15WarningsExact identifier
application number: M009
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEAPNAR PHARMA LPe4d785a7-a688-3acb-e053-2a95a90a6d2e2025-01-09Boxed warning, WarningsExact identifier
application number: M009
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEAPNAR PHARMA LPed43bf21-f3da-245c-e053-2995a90a504c2025-01-09Boxed warning, WarningsExact identifier
application number: M009
MECLIZINEMECLIZINE HCL 12.5 MGRUGBY LABORATORIES8a234ce3-eb6b-49dd-9d78-7fc7bdd49d352024-12-20WarningsExact identifier
application number: M009
MeclizineMECLIZINE HYDROCHLORIDEAdvanced Rx LLCb0a2a1f7-354e-48bd-9e98-9207bf9f53fd2024-11-27WarningsExact identifier
application number: M009
Dramamine, TRAVEL BASIXDIMENHYDRINATELil' Drug Store Products, Inc.960a642b-ee7c-4e92-9b5f-930425682dac2024-11-26WarningsExact identifier
application number: M009
Dramamine Less Drowsy, Lil Drug StoreMECLAZINE HYDROCHLORIDE TABLETLil' Drug Store Products, Inc.275b3377-9280-c12c-e063-6294a90a54212024-11-20WarningsExact identifier
application number: M009
PhysiciansCare Motion SicknessMECLIZINE HCLAcme United Corporationc4d3ea22-7c22-7311-e053-2a95a90a779c2024-11-12WarningsExact identifier
application number: M009
DRAMAMINE - NMECLIZINE HYDROCHLORIDEMedtech Products Inc.7fec7791-c242-4e43-8184-32820e657afb2024-10-25WarningsExact identifier
application number: M009
DRAMAMINEMECLIZINE HYDROCHLORIDEMedtech Products Inc.f8cf751a-9f19-4744-a350-cd22303435ee2024-10-25WarningsExact identifier
application number: M009
GravolDIMENHYDRINATEChurch & Dwight Co., Inc.d955f612-1265-f1be-e053-2995a90a53452024-07-18WarningsExact identifier
application number: M009
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC199ae195-4556-ee88-e063-6394a90a40d42024-06-10WarningsExact identifier
application number: M009
GravolDIMENHYDRINATEChurch & Dwight Co., Inc.d941705f-12a1-4757-e053-2995a90ad3fa2024-05-13WarningsExact identifier
application number: M009
Kids Gravol Chewables Motion Sickness DimenhydrinateDIMENHYDRINATEChurch & Dwight Co., Inc.cf6de950-a157-4be2-a302-0dc19511d2f22024-03-01WarningsExact identifier
application number: M009
Gravol Chewables Motion Sickness DimenhydrinateDIMENHYDRINATEChurch & Dwight Co., Inc.de5249f7-79fc-4f3c-965a-1e8ec978a0b72024-03-01WarningsExact identifier
application number: M009
Meclizine HClMECLIZINE HYDROCHLORIDE CHEWABLEBluePoint Laboratoriesd9cc2705-9dcc-0a73-e053-2995a90aafe62024-02-21WarningsExact identifier
application number: M009
Childrens AllergyDIPHENHYDRAMINE HYDROCHLORIDEDeMoulas Market Basketfd04fb94-f581-4ca2-b7ac-20359093863e2023-12-29WarningsExact identifier
application number: M009

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1245184dimenhyDRINATE 25 MG Chewable TabletPSN48e2e9ef-4c88-42ef-b825-d1b0074752754
1245186Dramamine 25 MG Chewable TabletPSN48e2e9ef-4c88-42ef-b825-d1b0074752754
1245186dimenhydrinate 25 MG Chewable Tablet [Dramamine]SBD48e2e9ef-4c88-42ef-b825-d1b0074752754
1245184dimenhydrinate 25 MG Chewable TabletSCD48e2e9ef-4c88-42ef-b825-d1b0074752754
1245186Dramamine 25 MG Chewable TabletSY48e2e9ef-4c88-42ef-b825-d1b0074752754
1245186Dramamine for Kids 25 MG Chewable TabletSY48e2e9ef-4c88-42ef-b825-d1b0074752754

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63029-910-01630290910011 BLISTER PACK in 1 CASE (63029-910-01) / 8 TABLET, CHEWABLE in 1 BLISTER PACK1 blister pack2012-02-152028-05-01NoNoCurrent