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 15 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Neosporin Kids Plus Pain Relief	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Kenvue Brands LLC	6752f0a0-2432-4d8b-8198-74ae96a68963	2024-11-13	Warnings	Exact identifier application number: M004
Neosporin Original	BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE	Kenvue Brands LLC	a3e6fe2e-1b74-4f22-9c7c-a00057439690	2024-11-13	Warnings	Exact identifier application number: M004
Neosporin Plus Pain Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Kenvue Brands LLC	32302dcd-f3f1-408b-ae5f-e7d8b666f68f	2024-11-13	Warnings	Exact identifier application number: M004
NEOSPORIN Plus BURN RELIEF	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Kenvue Brands LLC	3caa7fd1-bd66-427e-a6c0-1b137b205089	2024-11-13	Warnings	Exact identifier application number: M004
Simply Neosporin First Aid Antibiotic	BACITRACIN ZINC AND POLYMYXIN B SULFATE	Kenvue Brands LLC	68bfecea-095f-4d3f-b077-d86e1b9f1faa	2024-11-13	Warnings	Exact identifier application number: M004
Triple Antibiotic and Burn Relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE	CVS Pharmacy	fdc510b8-f3ad-4bd6-a8d0-1b81e9f30e13	2024-11-13	Warnings	Exact identifier application number: M004
BACITRACIN	BACITRACIN	ALLIED TRADE LINK LLC	253e5b98-c64f-3226-e063-6294a90a9352	2024-11-12	Warnings	Exact identifier application number: M004
TRIPLET ANTIBIOTIC	TRIPLET ANTIBIOTIC	ALLIED TRADE LINK LLC	26bd5ba4-264b-2a28-e063-6394a90ada80	2024-11-12	Warnings	Exact identifier application number: M004
basic care first aid antibiotic and burn relief	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE	Amazon.com Services LLC	0df4c44d-6912-4db9-a703-a82da4c8ae76	2024-11-11	Warnings	Exact identifier application number: M004
SUPER SENSITIVE HAND SANITIZER	ALCOHOL	ORGANIC & SUSTAINABLE BEAUTY	7d4a5b21-82d2-4904-9577-4a9b2579076e	2024-11-08	Warnings	Exact identifier application number: M004
dg health triple antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCL	Dolgencorp, LLC	4c97dada-966f-4de8-b5d9-e939cb456aea	2024-11-06	Warnings	Exact identifier application number: M004
TRIPLE ANTIBIOTIC	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	A-S Medication Solutions	de07139e-ece9-424b-8468-f5ed4bbb2b2b	2024-11-06	Warnings	Exact identifier application number: M004
good sense triple antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCL	L. Perrigo Company	e9e913d8-8ec8-4465-ad3a-b524f6710a0f	2024-11-06	Warnings	Exact identifier application number: M004
EUCALYPTUS EASE HAND SANITIZER	ALCOHOL	ORGANIC & SUSTAINABLE BEAUTY	09d77591-9472-4771-9090-3390bddf788a	2024-11-06	Warnings	Exact identifier application number: M004
Triple Antibiotic	POLYMYXIN B SULFATE, BACITRACIN ZINC AND NEOMYCIN SULFATE	A-S Medication Solutions	e115d413-e41c-4e43-8184-493d64dfcd9f	2024-11-06	Warnings	Exact identifier application number: M004
LEMON MYRTLE HAND SANITIZER	ALCOHOL	ORGANIC & SUSTAINABLE BEAUTY	f341b24c-9466-42f4-98fe-d1a122591915	2024-11-06	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	A-S Medication Solutions	00747e3a-389c-46bc-b6b9-9b3d1d98dbcf	2024-11-06	Warnings	Exact identifier application number: M004
Signature Care Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCL	Safeway	46db4b66-85a2-47fc-a643-df6477e2ddff	2024-11-06	Warnings	Exact identifier application number: M004
CALMING HAND SANITIZER	ALCOHOL	ORGANIC & SUSTAINABLE BEAUTY	ffcbe34d-3c53-47f9-9e4a-b5448afbbd5d	2024-11-05	Warnings	Exact identifier application number: M004
Antibiotic, Pain and Scar	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCL	CVS Pharmacy	8bb6cb64-103f-454a-95ad-c2c56b9cf71a	2024-11-05	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