dual action cream

Generic: neomycinsulfate,polymyxinbsulfate,pramoxinehcl

Labeler: trifecta pharmaceutical usa llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name dual action cream
Generic Name neomycinsulfate,polymyxinbsulfate,pramoxinehcl
Labeler trifecta pharmaceutical usa llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

neomycin sulfate 3.5 mg/g, polymyxin b sulfate 10000 [USP'U]/g, pramoxine hydrochloride 10 mg/g

Manufacturer
Trifecta Pharmaceutical USA LLC

Identifiers & Regulatory

Product NDC 69396-071
Product ID 69396-071_3d0e3bad-3feb-651e-e063-6394a90aef17
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M004
Listing Expiration 2026-12-31
Marketing Start 2021-01-06

Pharmacologic Class

Classes
aminoglycoside antibacterial [epc] aminoglycosides [cs] polymyxin-class antibacterial [epc] polymyxins [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69396071
Hyphenated Format 69396-071

Supplemental Identifiers

RxCUI
1359360
UPC
0860004834489
UNII
057Y626693 19371312D4 88AYB867L5

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name dual action cream (source: ndc)
Generic Name neomycinsulfate,polymyxinbsulfate,pramoxinehcl (source: ndc)
Application Number M004 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 3.5 mg/g
  • 10000 [USP'U]/g
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 BOX (69396-071-01) / 28.4 g in 1 TUBE
  • 2 TUBE in 1 BOX (69396-071-22) / 28.4 g in 1 TUBE
  • 4 TUBE in 1 BOX (69396-071-44) / 28.4 g in 1 TUBE
source: ndc

Packages (3)

69396-071-01 1 TUBE in 1 BOX (69396-071-01) / 28.4 g in 1 TUBE 69396-071-22 2 TUBE in 1 BOX (69396-071-22) / 28.4 g in 1 TUBE 69396-071-44 4 TUBE in 1 BOX (69396-071-44) / 28.4 g in 1 TUBE

Ingredients (3)

neomycin sulfate (3.5 mg/g) polymyxin b sulfate (10000 [USP'U]/g) pramoxine hydrochloride (10 mg/g)

Linked Drug Pages (1)

Dual Action Cream ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "3d0e3bad-3feb-651e-e063-6394a90aef17", "openfda": {"upc": ["0860004834489"], "unii": ["057Y626693", "19371312D4", "88AYB867L5"], "rxcui": ["1359360"], "spl_set_id": ["b84015ae-9c76-b1d7-e053-2a95a90a2cc8"], "manufacturer_name": ["Trifecta Pharmaceutical USA LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 BOX (69396-071-01)  / 28.4 g in 1 TUBE", "package_ndc": "69396-071-01", "marketing_start_date": "20210122"}, {"sample": false, "description": "2 TUBE in 1 BOX (69396-071-22)  / 28.4 g in 1 TUBE", "package_ndc": "69396-071-22", "marketing_start_date": "20250823"}, {"sample": false, "description": "4 TUBE in 1 BOX (69396-071-44)  / 28.4 g in 1 TUBE", "package_ndc": "69396-071-44", "marketing_start_date": "20241202"}], "brand_name": "Dual Action Cream", "product_id": "69396-071_3d0e3bad-3feb-651e-e063-6394a90aef17", "dosage_form": "CREAM", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Polymyxin-class Antibacterial [EPC]", "Polymyxins [CS]"], "product_ndc": "69396-071", "generic_name": "NeomycinSulfate,PolymyxinBSulfate,PramoxineHCL", "labeler_name": "Trifecta Pharmaceutical USA LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Dual Action Cream", "active_ingredients": [{"name": "NEOMYCIN SULFATE", "strength": "3.5 mg/g"}, {"name": "POLYMYXIN B SULFATE", "strength": "10000 [USP'U]/g"}, {"name": "PRAMOXINE HYDROCHLORIDE", "strength": "10 mg/g"}], "application_number": "M004", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20210106", "listing_expiration_date": "20261231"}