FDA.reportPublic FDA data

Triple Antibiotic

Product NDC
0472-0179
Requested package NDC
0472-0179-56
11-digit product format
004720179
Labeler code
0472
Product ID
0472-0179_fd86b484-bdb0-4119-8efb-818b0f9ce1ac
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Actavis Pharma, Inc.
Application
part333B
Marketing category
OTC MONOGRAPH FINAL
Marketing start
1997-05-01
Marketing end
2022-09-30
Substance
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Active strength
400 [iU]/g; mg/g; [iU]/g
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0472-01790472-0179-56DDiscontinued by firm2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0472-0179-34GM - Gram0472-0179f4ba8432-cf28-4d7e-86d8-ad3eaf115bdd12012-07-24
0472-0179-56GM - Gram0472-017902c98cec-6f68-468d-bf85-8c881eb854a212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACITRACIN ZINCACTIVE INGREDIENT89Y4M234ESTRIPLE ANTIBIOTIC (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) OINTMENT [ACTAVIS MID ATLANTIC LLC]2
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693TRIPLE ANTIBIOTIC (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) OINTMENT [ACTAVIS MID ATLANTIC LLC]2
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4TRIPLE ANTIBIOTIC (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) OINTMENT [ACTAVIS MID ATLANTIC LLC]2
BACITRACINACTIVE MOIETY58H6RWO52ITRIPLE ANTIBIOTIC (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) OINTMENT [ACTAVIS MID ATLANTIC LLC]2
NEOMYCINACTIVE MOIETYI16QD7X297TRIPLE ANTIBIOTIC (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) OINTMENT [ACTAVIS MID ATLANTIC LLC]2
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KTRIPLE ANTIBIOTIC (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) OINTMENT [ACTAVIS MID ATLANTIC LLC]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UTRIPLE ANTIBIOTIC (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) OINTMENT [ACTAVIS MID ATLANTIC LLC]2
BACITRACIN ZINCACTIVE INGREDIENT89Y4M234ESTRIPLE ANTIBIOTIC (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) OINTMENT [PREFERRED PHARMACEUTICALS, INC]1
BACITRACIN ZINCACTIVE INGREDIENT89Y4M234ESTRIPLE ANTIBIOTIC (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) OINTMENT [PROFICIENT RX LP]1
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693TRIPLE ANTIBIOTIC (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) OINTMENT [PROFICIENT RX LP]1
NEOMYCIN SULFATEACTIVE INGREDIENT057Y626693TRIPLE ANTIBIOTIC (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) OINTMENT [PREFERRED PHARMACEUTICALS, INC]1
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4TRIPLE ANTIBIOTIC (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) OINTMENT [PREFERRED PHARMACEUTICALS, INC]1
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4TRIPLE ANTIBIOTIC (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) OINTMENT [PROFICIENT RX LP]1
BACITRACINACTIVE MOIETY58H6RWO52ITRIPLE ANTIBIOTIC (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) OINTMENT [PREFERRED PHARMACEUTICALS, INC]1
BACITRACINACTIVE MOIETY58H6RWO52ITRIPLE ANTIBIOTIC (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) OINTMENT [PROFICIENT RX LP]1
NEOMYCINACTIVE MOIETYI16QD7X297TRIPLE ANTIBIOTIC (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) OINTMENT [PROFICIENT RX LP]1
NEOMYCINACTIVE MOIETYI16QD7X297TRIPLE ANTIBIOTIC (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) OINTMENT [PREFERRED PHARMACEUTICALS, INC]1
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KTRIPLE ANTIBIOTIC (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) OINTMENT [PREFERRED PHARMACEUTICALS, INC]1
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KTRIPLE ANTIBIOTIC (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) OINTMENT [PROFICIENT RX LP]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UTRIPLE ANTIBIOTIC (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) OINTMENT [PREFERRED PHARMACEUTICALS, INC]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UTRIPLE ANTIBIOTIC (BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE) OINTMENT [PROFICIENT RX LP]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSN149065ec-0c18-43e7-89de-6540bf48207b1
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSN72061450-572c-acb4-e053-2a95a90a0a991
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD149065ec-0c18-43e7-89de-6540bf48207b1
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD72061450-572c-acb4-e053-2a95a90a0a991
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY149065ec-0c18-43e7-89de-6540bf48207b1
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY72061450-572c-acb4-e053-2a95a90a0a991

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0472-0179-56004720179561 TUBE in 1 CARTON (0472-0179-56) > 28 g in 1 TUBE1 tube1997-05-012022-04-30NoNoCurrent