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 9 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Antibiotic Maximum Strength	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Walgreens	9a092f24-65b2-4b57-8103-265ea3e03311	2025-09-02	Warnings	Exact identifier application number: M004
Aerosoothe	TRIPLE ANTIBIOTIC OINTMENT	Aero Healthcare US LLC	2287a31c-750c-728d-e054-00144ff88e88	2025-08-29	Warnings	Exact identifier application number: M004
Triple Antibiotic Plus Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Chain Drug Marketing Association Inc.	3d4b3d73-171a-bc6a-e063-6394a90a69c1	2025-08-26	Warnings	Exact identifier application number: M004
Dual Action Cream	NEOMYCINSULFATE,POLYMYXINBSULFATE,PRAMOXINEHCL	Trifecta Pharmaceutical USA LLC	b84015ae-9c76-b1d7-e053-2a95a90a2cc8	2025-08-23	Warnings	Exact identifier application number: M004 ndc (product): 69396-071
Natureplex Antibiotic Plus Pain, Itch, Scar Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Natureplex LLC	f0af8829-72fb-46b1-9328-6f4920710bb1	2025-08-15	Warnings	Exact identifier application number: M004
PROHEAL TRIPLE ANTIBIOTIC	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Nantong Health & Beyond Hygienic Products Inc.	6c61d88e-4ced-4468-8f99-91652f7a03e4	2025-08-13	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	J&A Digital Inc.	9f006f16-083d-4e95-aec2-6ef83405f393	2025-08-07	Warnings	Exact identifier application number: M004
Vitacilina First Aid Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Taisho Pharmaceutical California Inc.	93fb9e05-f78c-4d37-b6f1-926cbcb2e7a7	2025-08-07	Warnings	Exact identifier application number: M004
SurviveX Triple Antibiotic	TRIPLE ANTIBIOTIC OINTMENT	Nantong Health & Beyond Hygienic Products Inc.	3bd25bb6-6486-8a0a-e063-6394a90a085c	2025-08-07	Warnings	Exact identifier application number: M004
Thera Plus Original Strength Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	FOURSTAR GROUP USA, INC.	09e8bdb7-dc14-4f28-8306-c0e2bf73f081	2025-07-31	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	Bryant Ranch Prepack	0c081802-429f-468f-9650-293cb7a1ad34	2025-07-29	Warnings	Exact identifier application number: M004
health and .beyond Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Nantong Health & Beyond Hygienic Products Inc.	0070ea5f-434d-53a7-e063-6294a90abf18	2025-07-27	Warnings	Exact identifier application number: M004
health and beyond TRIPLE ANTIBIOTIC	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Nantong Health & Beyond Hygienic Products Inc.	13cbe416-a146-447d-be36-8b3af9b3c895	2025-07-27	Warnings	Exact identifier application number: M004
AOSI HEALTHCARE TRIPLE ANTIBIOTIC	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Nantong Health & Beyond Hygienic Products Inc.	70c53369-7cf6-4352-a19f-c85a55c5a4bd	2025-07-27	Warnings	Exact identifier application number: M004
Pomada de Sulfa	NEOMYCIN SULFATE	Menper Distributors, Inc.	216f4d22-e5e8-46c8-a4ef-8d1532792b56	2025-07-22	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	STRATEGIC SOURCING SERVICES LLC	1bda9c30-8fc8-4814-b211-94550672b22f	2025-07-21	Warnings	Exact identifier application number: M004
Triple Antibiotic plus Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	STRATEGIC SOURCING SERVICES LLC	6a61c900-2dfc-4c07-8ae5-32ffbd89d2b6	2025-07-21	Warnings	Exact identifier application number: M004
FifthPulse Bacitracin Zinc 1oz	BACITRACIN ZINC	Front Pharmaceutical PLC	39f994d4-5f41-fb34-e063-6294a90a45ea	2025-07-15	Warnings	Exact identifier application number: M004
FifthPulse Bacitracin Zinc 4oz	BACITRACIN ZINC	Front Pharmaceutical PLC	39fa0e5f-b794-e1e3-e063-6394a90a4ce3	2025-07-15	Warnings	Exact identifier application number: M004
FifthPulse Hydrocortisone 1oz	HYDROCORTISONE	Front Pharmaceutical PLC	39fae2a4-902e-3c88-e063-6394a90acbd5	2025-07-15	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