Dramamine for Kids
Dramamine Tablets Chewable for Kids
Approved
Approval ID
48e2e9ef-4c88-42ef-b825-d1b007475275
Product Type
HUMAN OTC DRUG LABEL
Effective Date
May 6, 2025
Manufacturers
FDA
Medtech Products Inc.
DUNS: 122715688
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dimenhydrinate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63029-910
Application NumberM009
Product Classification
M
Marketing Category
C200263
G
Generic Name
Dimenhydrinate
Product Specifications
Route of AdministrationORAL
Effective DateMay 6, 2025
FDA Product Classification
INGREDIENTS (7)
DIMENHYDRINATEActive
Quantity: 25 mg in 1 1
Code: JB937PER5C
Classification: ACTIB
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
GRAPEInactive
Code: 6X543N684K
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT