PR
Approved
Approval ID
6f5b9e08-c445-4fac-e053-2a91aa0aa737
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Mar 3, 2025
Manufacturers
FDA
Amphp, Inc
DUNS: 081138140
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Menthol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72358-101
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
Menthol
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 3, 2025
FDA Product Classification
INGREDIENTS (14)
JOJOBA OILInactive
Code: 724GKU717M
Classification: IACT
POLYGLYCERYL-3 LAURATEInactive
Code: Y9ZSR39D0E
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ISOPROPYL PALMITATEInactive
Code: 8CRQ2TH63M
Classification: IACT
COCONUT OILInactive
Code: Q9L0O73W7L
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
HYDRATED SILICAInactive
Code: Y6O7T4G8P9
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
MENTHOLActive
Quantity: 0.5 g in 100 g
Code: L7T10EIP3A
Classification: ACTIB