Roman Swipes
Roman Swipes
Approved
Approval ID
7f0eac8c-7235-99d8-e053-2a91aa0a634e
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Feb 12, 2025
Manufacturers
FDA
Roman Health Ventures Inc.
DUNS: 081317350
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Benzocaine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72484-433
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
Benzocaine
Product Specifications
Route of AdministrationTOPICAL
Effective DateFebruary 12, 2025
FDA Product Classification
INGREDIENTS (4)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
BENZOCAINEActive
Quantity: 4 g in 100 mL
Code: U3RSY48JW5
Classification: ACTIB