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; PRAMOXINE HYDROCHLORIDE; POLYMYXIN B SULFATE
Active strength: 3.5; 10; 10000 mg/g; mg/g; [USP'U]/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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NEOMYCIN SULFATE	3.5 mg/g
PRAMOXINE HYDROCHLORIDE	10 mg/g
POLYMYXIN B SULFATE	10000 [USP'U]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
057Y626693	Internal UNII lookup
88AYB867L5	Internal UNII lookup
19371312D4	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1359360	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
b84015ae-9c76-b1d7-e053-2a95a90a2cc8	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
99e684e6-f435-feb8-d2bb-3a546f1cb768	Product name	2	20161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0c	Product name	1	20160603
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
b6082387-f592-1148-0844-bd068fd213fb	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69396-071-01	Dual Action Cream	28.4 g in 1 TUBE	CREAM	28.4	8
69396-071-01	Dual Action Cream	1 in 1 BOX	CREAM	1	8
69396-071-22	Dual Action Cream	28.4 g in 1 TUBE	CREAM	28.4	8
69396-071-22	Dual Action Cream	2 in 1 BOX	CREAM	2	8
69396-071-44	Dual Action Cream	28.4 g in 1 TUBE	CREAM	28.4	8
69396-071-44	Dual Action Cream	4 in 1 BOX	CREAM	4	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69396-071	DUAL ACTION CREAM (NEOMYCINSULFATE,POLYMYXINBSULFATE,PRAMOXINEHCL) CREAM [TRIFECTA PHARMACEUTICAL USA LLC]	6	Current NDC, Legacy NDC, 6 package rows	20250515_b84015ae-9c76-b1d7-e053-2a95a90a2cc8.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 10 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FifthPulse Hydrocortisone 4oz	HYDROCORTISONE	Front Pharmaceutical PLC	39fb29c8-6a28-e87e-e063-6294a90a78da	2025-07-15	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	Fred's, Inc.	41ee7a50-d36b-4214-b6f8-44f47ab44a84	2025-07-15	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	Lidl US, LLC	98389314-c2cf-4510-ab3d-41c4c4720019	2025-07-15	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B	Publix Super Markets Inc	72bdb96c-af93-4a9b-93d9-81a94b6ff756	2025-07-15	Warnings	Exact identifier application number: M004
Live Better Triple Antibiotic plus Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	The Great Atlantic & Pacific Tea Company	7e7a0b4c-67a9-42f3-aacd-2606fde25090	2025-07-15	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	Topco Associates LLC	55a8a52c-4d03-417d-9283-406f6879bcb5	2025-07-15	Warnings	Exact identifier application number: M004
Triple Antibiotic Plus Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	FRED'S, INC.	a44db5d1-7a74-44aa-9aa7-6247e771aaf2	2025-07-15	Warnings	Exact identifier application number: M004
Shopko Triple Antibiotic plus Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Shopko Stores Operating Co., LLC	5a9b2ea4-9b9d-4147-8aa0-7313d6be2cfa	2025-07-15	Warnings	Exact identifier application number: M004
sunmark triple antibiotic plus pain relief	POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE	Strategic Sourcing Services LLC	941a6a71-e898-4af3-989a-6d3aa3224338	2025-07-15	Warnings	Exact identifier application number: M004
TopCare Triple Antibiotic Plus Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Topco Associates LLC	0fc0dbc6-ca1d-42be-8016-68e64f119706	2025-07-15	Warnings	Exact identifier application number: M004
Triple Antibiotic Plus Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Walgreen Company	e2b7fc5b-c796-4ed1-aea7-4c810df250d5	2025-07-15	Warnings	Exact identifier application number: M004
Publix antibiotic plus Pain Relief	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Publix Super Markets Inc	d0193bf1-a257-490e-a058-5e6a514981da	2025-07-15	Warnings	Exact identifier application number: M004
Live Better Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	The Great Atlantic & Pacific Tea Company	7d3435ad-7d73-4db6-8019-3040b3dadfa9	2025-07-14	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	Wal-Mart Stores, Inc.	f5199476-1ce2-4a82-9685-40d78b7a8935	2025-07-14	Warnings	Exact identifier application number: M004
Double Antibiotic	BACITRACIN ZINC AND POLYMYXIN B SULFATE	STRATEGIC SOURCING SERVICES LLC	38414fff-8dad-44d0-9dfa-f89a63ef9b44	2025-07-14	Warnings	Exact identifier application number: M004
sunmark double antibiotic	BACITRACIN ZINC AND POLYMYXIN B SULFATE	Strategic Sourcing Services LLC	2868de5c-4894-45ee-9647-9acd3bde7cfc	2025-07-14	Warnings	Exact identifier application number: M004
Live Better Bacitracin Zinc	BACITRACIN ZINC	The Great Atlantic & Pacific Tea Company	6915940c-2eae-445c-ba58-e39d221e9d3d	2025-07-11	Warnings	Exact identifier application number: M004
Bacitracin Zinc	BACITRACIN ZINC	STRATEGIC SOURCING SERVICES LLC	4594948d-1f25-4d3c-a615-9e6edda05a10	2025-07-11	Warnings	Exact identifier application number: M004
Good Neighbor Pharmacy Bacitracin Zinc	BACITRACIN ZINC	AmerisourceBergen	3fb302b5-7273-412c-a2ba-b76183e3f179	2025-07-11	Warnings	Exact identifier application number: M004
TopCare Bacitracin Zinc	BACITRACIN ZINC	Topco Associates LLC	5b59e26d-cc25-49a6-ac8b-f79398e18f2d	2025-07-07	Warnings	Exact identifier application number: M004

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
057Y626693	NEOMYCIN SULFATE	1405-10-3	NEOMYCIN SULFATE
88AYB867L5	PRAMOXINE HYDROCHLORIDE	637-58-1	PRAMOXINE HYDROCHLORIDE
19371312D4	POLYMYXIN B SULFATE	1405-20-5	POLYMYXIN B SULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1359360	neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical Cream	PSN	b84015ae-9c76-b1d7-e053-2a95a90a2cc8	8
1359360	neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML / pramoxine hydrochloride 10 MG/ML Topical Cream	SCD	b84015ae-9c76-b1d7-e053-2a95a90a2cc8	8
1359360	neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10,000 UNT/ML / pramoxine (as pramoxine HCl) 1 % Topical Cream	SY	b84015ae-9c76-b1d7-e053-2a95a90a2cc8	8
1359360	neomycin 0.35 % / polymyxin B 10,000 UNT/ML / pramoxine HCl 1 % Topical Cream	SY	b84015ae-9c76-b1d7-e053-2a95a90a2cc8	8
1359360	neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical Cream	SY	b84015ae-9c76-b1d7-e053-2a95a90a2cc8	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69396-071-01	69396007101	1 TUBE in 1 BOX (69396-071-01) / 28.4 g in 1 TUBE	1 tube	2021-01-22	0000-00-00	No	No	Current
69396-071-22	69396007122	2 TUBE in 1 BOX (69396-071-22) / 28.4 g in 1 TUBE	2 tube	2025-08-23		No	No	Current
69396-071-44	69396007144	4 TUBE in 1 BOX (69396-071-44) / 28.4 g in 1 TUBE	4 tube	2024-12-02		No	No	Current