Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate
- Product NDC
- 0404-0167
- 11-digit product format
- 004040167
- Labeler code
- 0404
- Product ID
- 0404-0167_5d41a879-712e-ebe9-e063-6294a90a554c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Henry Schein
- Application
- M004
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-11-03
- Substance
- BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
- Active strength
- 400; 5; 5000 [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, Neomycin Sulfate, and Polymyxin B Sulfate
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BACITRACIN ZINC | 400 [iU]/g |
| NEOMYCIN SULFATE | 5 mg/g |
| POLYMYXIN B SULFATE | 5000 [iU]/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 89Y4M234ES | Internal UNII lookup |
| 057Y626693 | Internal UNII lookup |
| 19371312D4 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 204602 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| ead9496b-112e-59e6-e053-2995a90a768c | Available on FDA.report |
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 |
|---|---|---|---|---|---|
| 0404-0167-50 | 2024-01-31 | C162847 | 48780-1 | 1030e365-4e49-111a-e063-dadaa90a10e2 | 570-3128 Triple Antibiotic Ointment 0.9 g NDC 0404-0167-50 |
| 0404-0167-50 | 2024-01-31 | C162847 | 48780-1 | 1030e365-4e49-111a-e063-dadaa90a10e2 | 570-3128 Triple Antibiotic Ointment 0.9 g NDC 0404-0167-50 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0404-0167-50 | Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate | 144 in 1 BOX | OINTMENT | 144 | 4 | |
| 0404-0167-50 | Bacitracin Zinc, Neomycin Sulfate, and Polymyxin B Sulfate | 1728 in 1 CASE | OINTMENT | 1728 | 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 |
|---|---|---|---|---|---|---|
| Lynx LX0864 peachy-foam antiseptic handsoap | CHLOROXYLENOL | ABC Compounding Co., Inc. | dd8025cb-d160-83a4-e053-2a95a90a51ac | 2026-05-11 | Warnings | M004 |
| Satin Foam High Foaming Antiseptic Hand Wash | CHLOROXYLENOL | Certus Medical, Inc. | ea49da65-ae5e-bfde-e053-2a95a90adef2 | 2026-05-11 | Warnings | M004 |
| Freshands Premium Foamy Antibacterial Handsoap 6876 | CHLOROXYLENOL | Consolidated Chemicals, LLC | f17299a4-28d6-e65b-e053-2a95a90a05e7 | 2026-05-11 | Warnings | M004 |
| Harris Teeter Triple Antibiotic and Pain Relief | NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BACITRACIN ZINC, PRAMOXINE HCL | HARRIS TEETER LLC | 4b0c0a3c-7145-97ca-e063-6394a90a1a96 | 2026-05-07 | Warnings | M004 |
| Harris Teeter Triple Antibiotic | NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BACITRACIN ZINC | HARRIS TEETER LLC | 4e81590c-32d3-f8aa-e063-6294a90ab341 | 2026-05-06 | Warnings | M004 |
| FIRSTAR TRIPLE ANTIBIOTIC | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Nantong Health & Beyond Hygienic Products Inc. | 5b9434ad-83d7-4df3-bfef-3db152e6c6cc | 2026-05-04 | Warnings | M004 |
| oopsie First Aid | BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE | 4 Visions LLC | 50b21f0a-1e87-51ae-e063-6294a90a8a3c | 2026-04-30 | Warnings | M004 |
| First Aid Kit, Lil Drug Store | 5 ADHESIVE BANDAGES, 2 ANTIBIOTIC OINTMENTS | Lil' Drug Store Products, Inc. | 503c6c0e-3e1a-71ed-e063-6394a90abfa2 | 2026-04-24 | Warnings | M004 |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE. | TRIFECTA PHARMACEUTICALS USA LLC | 23a35ba8-ebc6-4252-bb88-ec237425056c | 2026-04-15 | Warnings | M004 |
| El Valle Gentian Violet | GENTIAN VIOLET 1% | Pharmadel LLC | fc75aa2b-0e6e-e2f7-e053-6294a90ac01f | 2026-04-13 | Warnings | M004 |
| Bacitracin Zinc | BACITRACIN ZINC | Sun Pharmaceutical Industries, Inc. | 4afdeedf-9cdf-47d6-919f-ea907fda0290 | 2026-04-10 | Warnings | M004 |
| Family Care Triple Antibiotic Original Formula 0.33oz | TRIPLE ANTIBIOTIC ORIGINAL FORMULA | United Exchange Corp | 4f1ef127-a67e-ca60-e063-6394a90a3a3d | 2026-04-10 | Warnings | M004 |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE | H E B | 2a143950-13b4-457e-91a4-c61a88aad84b | 2026-04-02 | Warnings | M004 |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE. | ProStat First Aid, LLC. | 4e54f479-ad87-e86b-e063-6394a90aa6d2 | 2026-03-31 | Warnings | M004 |
| El Valle Merthiolate | BENZALKONIUM CHLORIDE | Pharmadel LLC | fd7b28ca-9f71-0ff6-e053-6394a90a4822 | 2026-03-26 | Warnings | M004 |
| sojo Triple Antibiotic | TRIPLE ANTIBIOTIC | Jiangxi Yudexi Pharmaceutical Co., LTD | 4d8429bd-24b9-ad3c-e063-6294a90aeba0 | 2026-03-21 | Warnings | M004 |
| Neosporin Plus Pain Relief Clubtray | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE | Kenvue Brands LLC | f4545718-8643-a340-e053-2995a90a0079 | 2026-03-18 | Warnings | M004 |
| Bacitracin | BACITRACIN | Preferred Pharmaceuticals Inc. | 2f115e22-10f5-47fe-85df-f59e4387a373 | 2026-03-16 | Warnings | M004 |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE. | ProStat First Aid, LLC. | 4cd49c65-e347-7589-e063-6394a90a53bd | 2026-03-12 | Warnings | M004 |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE. | ProStat First Aid, LLC. | 4cc6d822-f383-2ceb-e063-6294a90aecc7 | 2026-03-11 | 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 | ead9496b-112e-59e6-e053-2995a90a768c | 4 |
| 204602 | bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical Ointment | SCD | ead9496b-112e-59e6-e053-2995a90a768c | 4 |
| 204602 | bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical Ointment | SY | ead9496b-112e-59e6-e053-2995a90a768c | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0404-0167-50 | 00404016750 | 1728 BOX in 1 CASE (0404-0167-50) / 144 PACKET in 1 BOX / .9 g in 1 PACKET | 1728 box | 2022-11-03 | 0000-00-00 | No | No | Current |