Bacitracin Zinc, Polymyxin B Sulfate, and Neomycin Sulfate
- Product NDC
- 0404-0171
- 11-digit product format
- 004040171
- Labeler code
- 0404
- Product ID
- 0404-0171_5d41b051-4fd6-6334-e063-6394a90a76e4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Bacitracin Zinc, Polymyxin B Sulfate, and Neomycin Sulfate
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Henry Schein
- Application
- M004
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-11-04
- Substance
- POLYMYXIN B SULFATE; NEOMYCIN SULFATE; BACITRACIN ZINC
- Active strength
- 50000; 5; 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
- 2027-12-31
- 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
- Bacitracin Zinc, Polymyxin B Sulfate, and Neomycin Sulfate
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| POLYMYXIN B SULFATE | 50000 [iU]/g |
| NEOMYCIN SULFATE | 5 mg/g |
| BACITRACIN ZINC | 400 [iU]/g |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 99e684e6-f435-feb8-d2bb-3a546f1cb768 | Product name | 2 | 20161117 |
| 25340b3b-3e4c-4ff8-abf6-3e62ec46bd0c | Product name | 1 | 20160603 |
| 2d352c73-a357-4193-a4de-dfdf9a2ac8e4 | Product name | 1 | 20150819 |
| b045ad64-0f28-9a02-2f9b-b34d94fb2278 | Product name | 1 | 20140508 |
| b6082387-f592-1148-0844-bd068fd213fb | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0404-0171-50 | 2024-01-31 | C162847 | 48780-1 | 1030e365-0ab0-111a-e063-dadaa90a10e2 | 570-3130 Triple Antibiotic NDC 0404-0171-50 |
| 0404-0171-50 | 2024-01-31 | C162847 | 48780-1 | 1030e365-0ab0-111a-e063-dadaa90a10e2 | 570-3130 Triple Antibiotic NDC 0404-0171-50 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0404-0171-50 | Bacitracin Zinc, Polymyxin B Sulfate, and Neomycin Sulfate | 72 in 1 CASE | OINTMENT | 72 | 4 | |
| 0404-0171-50 | Bacitracin Zinc, Polymyxin B Sulfate, and Neomycin Sulfate | 1 in 1 BOX | OINTMENT | 1 | 4 |
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE. | Front Pharmaceutical PLC | 3244d91e-6c6b-a351-e063-6294a90aa02d | 2025-04-08 | Warnings | M004 |
| Walgreens Advanced Wound Hydrogel | ALLANTOIN, BENZETHONIUM CHLORIDE | WALGREEN COMPANY | 25c6ada8-4a16-0896-e063-6294a90a0fdb | 2025-04-08 | Warnings | M004 |
| Honestly Battleborn First Aid for Real Man | TETRACYCLINE HYDROCHLORIDE | HONESTLY LLC | 13c1f2df-ba52-45e0-8868-a7518e9cdb55 | 2025-04-07 | Warnings | M004 |
| Honestly Battleborn First Aid for Real Man | TETRACYCLINE HYDROCHLORIDE | HONESTLY LLC | 93a6e02e-9f4b-4821-afa2-2029769f3088 | 2025-04-07 | Warnings | M004 |
| burn gel 01 | MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL | Cosmuses Cosmetics (Ningbo) Co., Ltd. | 3227bdc9-9323-68eb-e063-6294a90a29d2 | 2025-04-06 | Warnings | M004 |
| Vitastem ULTRA | BACITRACIN ZINC | ViaDerma Distribution, Inc | fd96cc09-8522-44a5-b034-0d30e532410d | 2025-04-03 | Warnings | M004 |
| Vitastem Ultra First Aid Antibiotic | BACITRACIN ZINC | Viaderma Distribution Inc | e6986bf9-22ea-4484-a709-27bc91c9058d | 2025-03-18 | Warnings | M004 |
| Redicare Triple Antibiotic First Aid | TRIPLE ANTIBIOTIC FIRST AID OINTMENT | Redicare LLC | 9468979d-446e-e4be-e053-2995a90a3f21 | 2025-03-05 | Warnings | M004 |
| Neosporin Original | BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE | Kenvue Brands LLC | 0ad21575-0e2d-24c2-e063-6394a90a616e | 2025-02-21 | Warnings | M004 |
| The Life Safety Pro Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Nantong Health & Beyond Hygienic Products Inc. | 64a7331f-98a6-4052-85b9-695c83b3bd16 | 2025-02-19 | Warnings | M004 |
| Vitastem | TETRACYCLINE HYDROCHLORIDE | ViaDerma Distribution, Inc. | a6630858-7038-425f-8a75-bb25f36a0dbe | 2025-02-18 | Warnings | M004 |
| Sheffield Triple Antibiotic | BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE | Sheffield Pharmaceuticals LLC | 1aa95046-c1f7-4fc7-acac-839065d998f6 | 2025-02-17 | Warnings | M004 |
| Equate | BACITRACIN ZINC ANTIBIOTIC OINTMENT | Walmart Inc. | 20908780-8803-4e19-e063-6394a90aab87 | 2025-02-01 | Warnings | M004 |
| Tetracyte Topical Tetracycline Hydrochloride | TETRACYCLINE HYDROCHLORIDE | VIADERMA DISTRIBUTION INC | 0961b097-ba41-40c2-aaec-dd291841bf09 | 2025-01-30 | Warnings | M004 |
| Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Welly Health PBC | 9446375d-4bb4-4bb1-bdc2-c18e995bfe26 | 2025-01-29 | Warnings | M004 |
| FAK Care4 Bus and School Yellow ORM D | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE, ISOPROPYL ALCOHOL, BENZOCAINE, ALCOHOL | GFA Production (Xiamen) Co., Ltd. | 3b5d07c6-bda2-4bc7-89b8-88280d11ed74 | 2025-01-22 | Warnings | M004 |
| Members Mark Alcohol Prep Pads, Sterile | ISOPROPYL ALCOHOL | Sam's Club West Inc. | 13001877-ae90-40be-899d-fb38f3a38b12 | 2025-01-22 | Warnings | M004 |
| Equate Antibiotic Plus Pain, Itch, Scar Relief | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE | WalMart | 2b743271-4f58-4ba1-a04c-560f7f8a547e | 2025-01-16 | Warnings | M004 |
| Equate Antibiotic Plus Pain Relief | NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE | WalMart | e08b427f-d070-4521-ad3c-faf295531791 | 2025-01-16 | Warnings | M004 |
| NATUREPLEX ANTIBIOTIC | BACITRACIN ZINC AND POLYMYXIN B SULFATE | Natureplex LLC | 86ea3452-c810-4c9a-9f52-bcb0688020f9 | 2025-01-15 | Warnings | M004 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 204602 | bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical Ointment | PSN | eadb847e-aefe-41cf-e053-2995a90af2cd | 4 |
| 204602 | bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical Ointment | SCD | eadb847e-aefe-41cf-e053-2995a90af2cd | 4 |
| 204602 | bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical Ointment | SY | eadb847e-aefe-41cf-e053-2995a90af2cd | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0404-0171-50 | 00404017150 | 72 BOX in 1 CASE (0404-0171-50) / 1 TUBE in 1 BOX / 28.4 g in 1 TUBE | 72 box | 2022-11-04 | 0000-00-00 | No | No | Current |