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 |
|---|---|---|---|---|---|---|
| First Aid Antibiotic plus Burn Relief | BACITRACINZINC,NEOMYCINSULFATE,POLYMXINBSULFATE,PRAMOXINEHCI | Trifecta Pharmaceuticals USA LLC | 048871e2-c917-292d-e063-6394a90af130 | 2024-12-18 | Warnings | M004 |
| TheraCare Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE | Veridian Healthcare | 0c3fc798-9a97-5316-e063-6394a90a6830 | 2024-12-18 | Warnings | M004 |
| Bacitracin Zinc | BACITRACIN ZINC | Rugby Laboratories | ac3c9897-c812-1360-e053-2a95a90ad591 | 2024-12-17 | Warnings | M004 |
| Major Bacitracin | BACITRACIN ZINC | Major Pharmaceuticals | a23ce772-7078-0a4b-e053-2995a90aff0d | 2024-12-17 | Warnings | M004 |
| Bacitracin Zinc | BACITRACIN ZINC | Trifecta Pharmaceuticals USA LLC | eea0d90c-914b-2624-e053-2a95a90a34c9 | 2024-12-13 | Warnings | M004 |
| OP First Aid Series TRIPLE ANTIBIOTIC | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Nantong Health & Beyond Hygienic Products Inc. | cadebf07-dd48-4855-8296-7a91e28d7123 | 2024-12-05 | Warnings | M004 |
| triple antibiotic and pain relief | BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE | CVS Pharmacy | f0864d78-23e6-4e6c-bc67-7ba3e6dd862c | 2024-12-03 | Warnings | M004 |
| triple antibiotic | BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE | Publix Super Markets Inc | 330c7b7a-d0d1-42dc-b8f7-9c96aeaf69f9 | 2024-11-25 | Warnings | M004 |
| WinCo Maximum Strength Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POYMYXIN B SULFATE, AND PRAMOXINE HYDROCHRLORIDE | WinCo Foods, LLC | 01b03c7e-6c4e-43aa-8480-aff1c2688f7f | 2024-11-21 | Warnings | M004 |
| WinCo Original Strength Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE | WinCo Foods, LLC | e364b623-6e20-4894-8d4c-5c739be78f86 | 2024-11-21 | Warnings | M004 |
| Winco Bacitracin Zinc | BACITRACIN ZINC | WinCo Foods, LLC | dcdf647f-fa32-4b72-b714-a77e8e332358 | 2024-11-21 | Warnings | M004 |
| Walgreens Multi-Antibiotic with Pain Relief Cream | POLYMYXIN B SULFATE, NEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDE | Walgreens Company | f4feccc3-ac25-4d8a-9b68-9a24f755524a | 2024-11-20 | Warnings | M004 |
| Walgreens Kids Multi-Antibiotic with Pain Relief Cream | POLYMYXIN B SULFATE, NEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDE | Walgreens Company | fbc364d7-d8b8-43f5-99cc-290438f3982b | 2024-11-20 | Warnings | M004 |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Acme United Corporation | f9a48f73-aa12-cf68-e053-6294a90a8e53 | 2024-11-19 | Warnings | M004 |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE | Acme United Corporation | e55cbf7e-c955-7f1a-e053-2a95a90a3f28 | 2024-11-19 | Warnings | M004 |
| First Aid Only Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Acme United Corporation | f4eba34c-ce31-3004-e053-2995a90a245b | 2024-11-19 | Warnings | M004 |
| First Aid Only Neomycin Antibiotic | NEOMYCIN SULFATE | Acme United Corporation | c651e98e-aabe-de46-e053-2a95a90a6307 | 2024-11-19 | Warnings | M004 |
| Neosporin Original | BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE | Kenvue Brands LLC | f07d3bca-4312-46ed-b0c4-f886c01bd095 | 2024-11-14 | Warnings | M004 |
| Polysporin First Aid Antibiotic | BACITRACIN ZINC AND POLYMYXIN B SULFATE | Kenvue Brands LLC | e0fcf83e-a374-4fc0-a629-873033054392 | 2024-11-14 | Warnings | M004 |
| Neosporin Pain Itch Scar | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE | Kenvue Brands LLC | 55392c48-b5d8-44cd-8c10-6d8668349848 | 2024-11-13 | 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 |