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 4 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lynx LX0864 peachy-foam antiseptic handsoap	CHLOROXYLENOL	ABC Compounding Co., Inc.	dd8025cb-d160-83a4-e053-2a95a90a51ac	2026-05-11	Warnings	Exact identifier application number: M004
Satin Foam High Foaming Antiseptic Hand Wash	CHLOROXYLENOL	Certus Medical, Inc.	ea49da65-ae5e-bfde-e053-2a95a90adef2	2026-05-11	Warnings	Exact identifier application number: M004
Freshands Premium Foamy Antibacterial Handsoap 6876	CHLOROXYLENOL	Consolidated Chemicals, LLC	f17299a4-28d6-e65b-e053-2a95a90a05e7	2026-05-11	Warnings	Exact identifier application number: M004
Harris Teeter Triple Antibiotic and Pain Relief	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BACITRACIN ZINC, PRAMOXINE HCL	HARRIS TEETER LLC	4b0c0a3c-7145-97ca-e063-6394a90a1a96	2026-05-07	Warnings	Exact identifier application number: M004
Harris Teeter Triple Antibiotic	NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BACITRACIN ZINC	HARRIS TEETER LLC	4e81590c-32d3-f8aa-e063-6294a90ab341	2026-05-06	Warnings	Exact identifier application number: M004
FIRSTAR TRIPLE ANTIBIOTIC	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Nantong Health & Beyond Hygienic Products Inc.	5b9434ad-83d7-4df3-bfef-3db152e6c6cc	2026-05-04	Warnings	Exact identifier application number: M004
oopsie First Aid	BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE	4 Visions LLC	50b21f0a-1e87-51ae-e063-6294a90a8a3c	2026-04-30	Warnings	Exact identifier application number: M004
First Aid Kit, Lil Drug Store	5 ADHESIVE BANDAGES, 2 ANTIBIOTIC OINTMENTS	Lil' Drug Store Products, Inc.	503c6c0e-3e1a-71ed-e063-6394a90abfa2	2026-04-24	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.	TRIFECTA PHARMACEUTICALS USA LLC	23a35ba8-ebc6-4252-bb88-ec237425056c	2026-04-15	Warnings	Exact identifier application number: M004
El Valle Gentian Violet	GENTIAN VIOLET 1%	Pharmadel LLC	fc75aa2b-0e6e-e2f7-e053-6294a90ac01f	2026-04-13	Warnings	Exact identifier application number: M004
Bacitracin Zinc	BACITRACIN ZINC	Sun Pharmaceutical Industries, Inc.	4afdeedf-9cdf-47d6-919f-ea907fda0290	2026-04-10	Warnings	Exact identifier application number: M004
Family Care Triple Antibiotic Original Formula 0.33oz	TRIPLE ANTIBIOTIC ORIGINAL FORMULA	United Exchange Corp	4f1ef127-a67e-ca60-e063-6394a90a3a3d	2026-04-10	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE	H E B	2a143950-13b4-457e-91a4-c61a88aad84b	2026-04-02	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.	ProStat First Aid, LLC.	4e54f479-ad87-e86b-e063-6394a90aa6d2	2026-03-31	Warnings	Exact identifier application number: M004
El Valle Merthiolate	BENZALKONIUM CHLORIDE	Pharmadel LLC	fd7b28ca-9f71-0ff6-e053-6394a90a4822	2026-03-26	Warnings	Exact identifier application number: M004
sojo Triple Antibiotic	TRIPLE ANTIBIOTIC	Jiangxi Yudexi Pharmaceutical Co., LTD	4d8429bd-24b9-ad3c-e063-6294a90aeba0	2026-03-21	Warnings	Exact identifier application number: M004
Neosporin Plus Pain Relief Clubtray	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE	Kenvue Brands LLC	f4545718-8643-a340-e053-2995a90a0079	2026-03-18	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	Preferred Pharmaceuticals Inc.	2f115e22-10f5-47fe-85df-f59e4387a373	2026-03-16	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.	ProStat First Aid, LLC.	4cd49c65-e347-7589-e063-6394a90a53bd	2026-03-12	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.	ProStat First Aid, LLC.	4cc6d822-f383-2ceb-e063-6294a90aecc7	2026-03-11	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