Mineral Oil
Drug Facts
Approved
Approval ID
0dd5380e-9671-4a2b-a2ce-6477503d06d2
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 9, 2025
Manufacturers
FDA
TOP CARE (Topco Associates LLC)
DUNS: 006935977
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Mineral Oil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36800-334
Application NumberM007
Product Classification
M
Marketing Category
C200263
G
Generic Name
Mineral Oil
Product Specifications
Route of AdministrationORAL, TOPICAL
Effective DateApril 9, 2025
FDA Product Classification
INGREDIENTS (2)
MINERAL OILActive
Quantity: 100 mg in 100 mL
Code: T5L8T28FGP
Classification: ACTIB
TOCOPHEROLInactive
Code: R0ZB2556P8
Classification: IACT