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 |
|---|---|---|---|---|---|---|
| Balma Septic Antiseptic Hand Wash | BENZALKONIUM CHLORIDE | Rochester Midland Corporation | 1b8e0a27-dcdd-4d07-b0f2-55cf74a9b528 | 2025-01-10 | Warnings | M004 |
| LX0380 Lynx glacier fresh Antiseptic Hand and Body Wash 6380 | CHLOROXYLENOL | ABC Compounding Co., Inc. | efa3938f-64de-77ba-e053-2a95a90ac840 | 2025-01-10 | Warnings | M004 |
| Bacitracin | BACITRACIN | A-S Medication Solutions | 64aa660d-2d69-48e8-bd0d-4876815d89ff | 2025-01-08 | Warnings | M004 |
| Bacitracin | BACITRACIN | Water-Jel Technologies | 412928a1-3708-4fa8-99c5-aaa2b079cf6e | 2025-01-06 | Warnings | M004 |
| AVON HeXashield Triple Antibiotic with Pain Relief | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCL | Tai Guk Pharm. Co., Ltd. | 8e0cb861-d8aa-1f71-e053-2a95a90aaa88 | 2025-01-01 | Warnings | M004 |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Trifecta Pharmaceuticals USA LLC | 087694c2-4b1b-e293-e063-6294a90a961f | 2024-12-31 | Warnings | M004 |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE | TRIFECTA PHARMACEUTICALS USA LLC | 0c017b10-29b6-e30f-e063-6294a90a8a3c | 2024-12-31 | Warnings | M004 |
| Triple Antibiotic and Pain Relief | BACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINE | Trifecta Pharmaceutical USA LLC | 0bf08cf6-be3f-f9aa-e063-6294a90a4393 | 2024-12-31 | Warnings | M004 |
| Single Antibiotic with Bacitracin | BACITRACIN ZINC | Randob Labs Ltd. | 2a807f1b-986f-a9ea-e063-6394a90aed25 | 2024-12-30 | Warnings | M004 |
| Tripleantibioticapainscaritch | FAMILY WELLNESS BACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINEHCL | Trifecta Pharmaceutical USA LLC | 935106c6-8a9e-07fa-e053-2a95a90a2484 | 2024-12-20 | Warnings | M004 |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE. | TRIFECTA PHARMACEUTICALS USA LLC | 00c52a31-9bfa-a8bf-e063-6294a90ac4d7 | 2024-12-20 | Warnings | M004 |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE | Trifecta Pharmaceuticals Usa Llc | d04b397c-1608-4fd9-be28-ef7285d6a996 | 2024-12-20 | Warnings | M004 |
| Tripleantibioticointmentandpainrelief | FAMILY WELLNESS BACITRACIN,NEOMYCIN,POLYMYXINB,PRAMOXINE | Trifecta Pharmaceutical USA LLC | 91575333-5268-5d8f-e053-2a95a90a7a89 | 2024-12-20 | Warnings | M004 |
| Premier Value Max Strength Antibiotic plus pain relief | PREMIER VALUE NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCL | Pharmacy Value Alliance LLC | 9767821e-054b-3bd3-e053-2a95a90a4b0e | 2024-12-20 | Warnings | M004 |
| Premier Value Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Premier Value Alliance LLC. | ab843664-a1e0-6716-e053-2995a90a2063 | 2024-12-20 | Warnings | M004 |
| Premier Value Bacitracin Zinc | BACITRACIN ZINC | Pharmacy Value Alliance LLC | 99d789be-aa85-0917-e053-2a95a90acd13 | 2024-12-20 | Warnings | M004 |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Premier Value Alliance LLC. | ab863d90-1a8f-3c1f-e053-2a95a90aa0a7 | 2024-12-20 | Warnings | M004 |
| Family Wellness First Aid Antibiotic | FAMILY WELLNESS BACITRACIN ZINC, POLYMYXIN B SULFATE | Trifecta Pharmaceuticals USA, LLC | 9157681a-3ed1-096e-e053-2a95a90a05e3 | 2024-12-18 | Warnings | M004 |
| Family Wellness Original | FAMILY WELLNESS BACITRACIN, NEOMYCIN, POLYMYXIN B | Trifecta Pharmaceuticals USA LLC. | 915759af-0d4f-6a87-e053-2a95a90acbd6 | 2024-12-18 | Warnings | M004 |
| Family Wellness Pain Scar Itch | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCL | Trifecta Pharmaceutical USA LLC | 9e507ec5-310d-3a21-e053-2a95a90a15a6 | 2024-12-18 | 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 |