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 | BACITRACIN ZINC | TARGET Corporation | 4d8e7146-9215-417e-93be-af706502cfee | 2025-07-07 | Warnings | M004 |
| TRIPLE ANTIBIOTIC PLUS PAIN RELIEF | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE | GENOMMA LAB USA, INC. | 506fcda5-df44-49c8-8dbd-cab7434b06b2 | 2025-07-02 | Warnings | M004 |
| DG Poly Antibiotic First Aid Antibiotic | BACITRACIN AND POLYMYXIN B SULFATE | Dollar General | 4d710928-5a7d-4f1a-aea0-be7fe599ae0c | 2025-07-02 | Warnings | M004 |
| Curad Maximum Strength Triple Antibiotic | BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE | Medline Industries, LP | 99e9c394-ebf1-7a27-e053-2a95a90ab157 | 2025-07-01 | Warnings | M004 |
| Double Antibiotic | BACITRACIN ZINC AND POLYMYXIN B SULFATE | Sun Pharmaceutical Industries, Inc. | 7e8af528-eb25-4f93-9b35-8fff635932cc | 2025-07-01 | Warnings | M004 |
| Triple Antibiotic plus Pain Relief Maximum Strength | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND PRAMOXINE HYDROCHLORIDE | Chain Drug Consortium, LLC | 55ef2205-aaf1-4aa4-917f-2b4cfa43b77e | 2025-07-01 | Warnings | M004 |
| Bacitracin | BACITRACIN | RUGBY LABORATORIES | aa9f414e-d8de-417d-9ccd-027d5a5f5499 | 2025-06-27 | Warnings | M004 |
| Meret Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Nantong Health & Beyond Hygienic Products Inc. | 385d8642-9eae-a750-e063-6394a90a7931 | 2025-06-24 | Warnings | M004 |
| ProCure Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Twin Med LLC | 37a3916f-cc1a-41a0-e063-6394a90a35ed | 2025-06-16 | Warnings | M004 |
| Bacitracin Zinc | FIRST AID ANTIBIOTIC | Dynarex Corporation | 82cf8dd0-eef6-5871-e053-2991aa0a38cf | 2025-06-16 | Warnings | M004 |
| Sion Biotext Bacitracin Zinc | BACITRACIN ZINC | Sion Biotext Medical Ltd | 35056345-f325-99e8-e063-6294a90a2d7e | 2025-06-12 | Warnings | M004 |
| ProCure Bacitracin Zinc | BACITRACIN ZINC | Twin Med LLC | 36da7993-7c65-7430-e063-6294a90a0626 | 2025-06-05 | Warnings | M004 |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, POLYMYXIN B | J&A Digital Inc. | 9b8f2046-5886-440d-a7fc-a71138d7f34b | 2025-06-02 | Warnings | M004 |
| Lights Povidone Iodine Scrub | POVIDONE-IODINE | Lights Medical Manufacture Co., Ltd. | 5e1eef53-c2c7-477e-9ee4-19c01c1881e5 | 2025-05-20 | Warnings | M004 |
| Bacitracin | BACITRACIN ZINC | Trifecta Pharmaceuticals USA, LLC. | 4a9fe0fa-5549-4e06-e054-00144ff8d46c | 2025-05-15 | Warnings | M004 |
| SionBiotext Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Sion Biotext Medical Ltd | 35083d42-5823-eeb1-e063-6294a90acafa | 2025-05-13 | Warnings | M004 |
| Multi Action | BACITRACINZINC,NEOMYCINSULFATE,POLYMYXINBSULFATE,PRAMOXINEHCL | Trifecta Pharmaceutical USA LLC | b98082f3-be95-49fb-e053-2a95a90a37b8 | 2025-05-13 | Warnings | M004 |
| Leader Triple antibiotic and pain relief | BACITRACIN,NEOMYCIN,POLYMXIN, PRAMOXINE | Cardinal Health 110 dba LEADER | f4c521d9-dd05-1c23-e053-2995a90a6e2c | 2025-05-13 | Warnings | M004 |
| Tripleantibioticointmentandpainrelief | BACITRACIN,NEOMYCIN,POLYMXIN, PRAMOXINE | Trifecta Pharmaceuticals USA | 34f1db74-6506-d53d-e063-6394a90ac400 | 2025-05-12 | Warnings | M004 |
| Triple Antibiotic plus Lidocaine | BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE, LIDOCAINE | TRIFECTA PHARMACEUTICALS USA LLC | 14fda967-54ba-c964-e063-6294a90a21ee | 2025-04-24 | 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 |