Motion Sickness
Foster and Thrive 44-198
Approved
Approval ID
be8f91d4-6e4f-4d47-93e9-7fb91160b7df
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 8, 2025
Manufacturers
FDA
Strategic Sourcing Services LLC
DUNS: 116956644
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 Code70677-1087
Application NumberM009
Product Classification
M
Marketing Category
C200263
G
Generic Name
Dimenhydrinate
Product Specifications
Route of AdministrationORAL
Effective DateApril 8, 2025
FDA Product Classification
INGREDIENTS (7)
DIMENHYDRINATEActive
Quantity: 50 mg in 1 1
Code: JB937PER5C
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT