FDA.reportPublic FDA data

Dual Action Cream

Product NDC
69396-071
11-digit product format
693960071
Labeler code
69396
Product ID
69396-071_3d0e3bad-3feb-651e-e063-6394a90aef17
Type
HUMAN OTC DRUG
Nonproprietary name
NeomycinSulfate,PolymyxinBSulfate,PramoxineHCL
Dosage form
CREAM
Route
TOPICAL
Labeler
Trifecta Pharmaceutical USA LLC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-01-06
Substance
NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
Active strength
3.5; 10000; 10 mg/g; [USP'U]/g; mg/g
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dual Action Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEOMYCIN SULFATE3.5 mg/g
POLYMYXIN B SULFATE10000 [USP'U]/g
PRAMOXINE HYDROCHLORIDE10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii057Y626693, 19371312D4, 88AYB867L5
Rxcui1359360

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-071-01Dual Action Cream28.4 g in 1 TUBECREAM28.48
69396-071-01Dual Action Cream1 in 1 BOXCREAM18
69396-071-22Dual Action Cream28.4 g in 1 TUBECREAM28.48
69396-071-22Dual Action Cream2 in 1 BOXCREAM28
69396-071-44Dual Action Cream28.4 g in 1 TUBECREAM28.48
69396-071-44Dual Action Cream4 in 1 BOXCREAM48

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-071DUAL ACTION CREAM (NEOMYCINSULFATE,POLYMYXINBSULFATE,PRAMOXINEHCL) CREAM [TRIFECTA PHARMACEUTICAL USA LLC]6Current NDC, Legacy NDC, 6 package rows20250515_b84015ae-9c76-b1d7-e053-2a95a90a2cc8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1359360neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical CreamPSNb84015ae-9c76-b1d7-e053-2a95a90a2cc88
1359360neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML / pramoxine hydrochloride 10 MG/ML Topical CreamSCDb84015ae-9c76-b1d7-e053-2a95a90a2cc88
1359360neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10,000 UNT/ML / pramoxine (as pramoxine HCl) 1 % Topical CreamSYb84015ae-9c76-b1d7-e053-2a95a90a2cc88
1359360neomycin 0.35 % / polymyxin B 10,000 UNT/ML / pramoxine HCl 1 % Topical CreamSYb84015ae-9c76-b1d7-e053-2a95a90a2cc88
1359360neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical CreamSYb84015ae-9c76-b1d7-e053-2a95a90a2cc88

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69396-071-01693960071011 TUBE in 1 BOX (69396-071-01) / 28.4 g in 1 TUBE1 tube2021-01-220000-00-00NoNoCurrent
69396-071-22693960071222 TUBE in 1 BOX (69396-071-22) / 28.4 g in 1 TUBE2 tube2025-08-23NoNoHistorical
69396-071-44693960071444 TUBE in 1 BOX (69396-071-44) / 28.4 g in 1 TUBE4 tube2024-12-02NoNoHistorical