PENIMIXCINA
- Product NDC
- 69729-615
- 11-digit product format
- 697290615
- Labeler code
- 69729
- Product ID
- 69729-615_18ae5c8b-2507-fac3-e063-6394a90a6072
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- BACITRACIN, NEOMYCIN SULFATE, POLYMIXIN B SULFATE, PRAMOXINE HYDROCHLORIDE
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- OPMX LLC
- Application
- M004
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2018-09-05
- Substance
- BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PRAMOXINE HYDROCHLORIDE
- Active strength
- 500; 5; 5000; 10 [iU]/g; mg/g; [iU]/g; mg/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
- 2026-12-31
- Current FDA listing
- Yes
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 69729-615-05 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 69729-615-05 | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 69729-615-05 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 69729-615-05 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 69729-615-05 | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 69729-615-05 | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 69729-615-05 | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 69729-615-05 | 9bebd1f3094a… | 5416666fcb17… |
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
- PENIMIXCINA
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BACITRACIN ZINC | 500 [iU]/g |
| NEOMYCIN SULFATE | 5 mg/g |
| POLYMYXIN B SULFATE | 5000 [iU]/g |
| PRAMOXINE HYDROCHLORIDE | 10 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 89Y4M234ES | Internal UNII lookup |
| 057Y626693 | Internal UNII lookup |
| 19371312D4 | Internal UNII lookup |
| 88AYB867L5 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2055751 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 92bcbc02-9683-4117-af2b-6d4687796f1f | 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 |
| 58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8 | Product name | 1 | 20140508 |
| a7051cba-790b-a699-81f8-dbbbdbd9b5ac | Product name | 1 | 20140508 |
| b045ad64-0f28-9a02-2f9b-b34d94fb2278 | Product name | 1 | 20140508 |
| b6082387-f592-1148-0844-bd068fd213fb | Product name | 1 | 20140508 |
| da108d9e-edc8-17a3-8c28-3251c6a8accc | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2024-05-19 | Penimixcina - First Aid Ointment |
| 2024-01-30 | Penimixcina - First Aid Ointment |
| 2022-10-19 | Penimixcina - First Aid Ointment |
| 2020-01-31 | Penimixcina - First Aid Ointment |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69729-615-01 | PENIMIXCINA | 14 g in 1 TUBE | OINTMENT | 14 | 5 | |
| 69729-615-05 | PENIMIXCINA | 1 in 1 BOX | OINTMENT | 1 | 5 |
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 |
|---|---|---|---|---|
| 2055751 | bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT / pramoxine HCl 10 MG per GM Topical Ointment | PSN | 92bcbc02-9683-4117-af2b-6d4687796f1f | 5 |
| 2055751 | bacitracin 0.5 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG / pramoxine hydrochloride 0.01 MG/MG Topical Ointment | SCD | 92bcbc02-9683-4117-af2b-6d4687796f1f | 5 |
| 2055751 | bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT / pramoxine HCl 10 MG per GM Topical Ointment | SY | 92bcbc02-9683-4117-af2b-6d4687796f1f | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69729-615-01 | 69729061501 | 14 g in 1 TUBE | 14 g | Historical | ||||
| 69729-615-05 | 69729061505 | 1 TUBE in 1 BOX (69729-615-05) / 14 g in 1 TUBE (69729-615-01) | 1 tube | 2018-09-05 | 0000-00-00 | No | No | Current |