HemorrhoidalOintment
Hemorrhoidal Ointment
Approved
Approval ID
4eb3c9ac-268a-5246-e054-00144ff88e88
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Feb 7, 2025
Manufacturers
FDA
Trifecta Pharmaceuticals USA LLC
DUNS: 079424163
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Mineral Oil, Petrolatum, Phenylephrine HCI
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69396-020
Application NumberM015
Product Classification
M
Marketing Category
C200263
G
Generic Name
Mineral Oil, Petrolatum, Phenylephrine HCI
Product Specifications
Route of AdministrationTOPICAL
Effective DateFebruary 7, 2025
FDA Product Classification
INGREDIENTS (15)
MINERAL OILActive
Quantity: 14 g in 100 g
Code: T5L8T28FGP
Classification: ACTIB
PETROLATUMActive
Quantity: 74.9 g in 100 g
Code: 4T6H12BN9U
Classification: ACTIB
PHENYLEPHRINE HYDROCHLORIDEActive
Quantity: 0.25 g in 100 g
Code: 04JA59TNSJ
Classification: ACTIB
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
WHITE WAXInactive
Code: 7G1J5DA97F
Classification: IACT
THYME OILInactive
Code: 2UK410MY6B
Classification: IACT
LANOLINInactive
Code: 7EV65EAW6H
Classification: IACT
PARAFFINInactive
Code: I9O0E3H2ZE
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
BEESWAXInactive
Code: 2ZA36H0S2V
Classification: IACT
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
LAURETH-23Inactive
Code: N72LMW566G
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 6/9/2025
