PENTREXCILINA TRIPLE ANTIBIOTIC
- Product NDC
- 69729-616
- 11-digit product format
- 697290616
- Labeler code
- 69729
- Product ID
- 69729-616_18ac00d7-fdc6-65b1-e063-6394a90ac204
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE
- 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 | 69729-616-61 | 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 | 69729-616-61 | 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 | 69729-616-61 | 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 | 69729-616-61 | 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 | 69729-616-61 | 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 | 69729-616-61 | 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 | 69729-616-61 | 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 | 69729-616-61 | 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
- PENTREXCILINA TRIPLE ANTIBIOTIC
- Brand name suffix
- PLUS PAIN RELIEF
- 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 |
|---|---|
| 7c0d3cdf-af50-4a65-a01b-a33510feeb94 | 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 |
|---|---|
| 2024-05-17 | Pentrexcilina Triple Antibiotic |
| 2024-01-30 | Pentrexcilina Triple Antibiotic |
| 2022-10-19 | Pentrexcilina Triple Antibiotic |
| 2020-01-31 | Pentrexcilina Triple Antibiotic |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69729-616-01 | PENTREXCILINA TRIPLE ANTIBIOTICPLUS PAIN RELIEF | 14 g in 1 TUBE | OINTMENT | 14 | 3 | |
| 69729-616-61 | PENTREXCILINA TRIPLE ANTIBIOTICPLUS PAIN RELIEF | 1 in 1 BOX | OINTMENT | 1 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69729-616 | PENTREXCILINA TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE) OINTMENT [OPMX LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240518_7c0d3cdf-af50-4a65-a01b-a33510feeb94.zip |
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 |
|---|---|---|---|---|---|---|
| Bacitracin Zinc | BACITRACIN ZINC | Henry Schein | eaf1555d-7a3d-7ccb-e053-2995a90af62e | 2025-11-25 | Warnings | M004 |
| Bacitracin Zinc, Polymyxin B Sulfate, and Neomycin Sulfate | BACITRACIN ZINC, POLYMYXIN B SULFATE, AND NEOMYCIN SULFATE | Henry Schein | eadb847e-aefe-41cf-e053-2995a90af2cd | 2025-11-25 | Warnings | M004 |
| Neosporin Plus Lidocaine | BACITRACIN, NEOMYCIN, POLYMYXIN B, LIDOCAINE | Kenvue Brands LLC | e450b6a1-a8da-e5db-e053-2995a90a0ef0 | 2025-11-24 | Warnings | M004 |
| ElixirZincoCare | ZINC OXIDE 20% | ELIXIR HEALTHCARE USA, LLC. | bac18496-3b76-4faf-abde-968d79b718d8 | 2025-11-22 | Warnings | M004 |
| Hand-Aid | ALCOHOL | ABC Compounding Co., Inc. | 788d7584-bc33-49e8-90fd-767045ea2914 | 2025-11-19 | Warnings | M004 |
| VITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTIC | NEOMYCIN SULFATE | Compania Internacional de Comercio, S.A.P.I de C.V. | ba7a3331-466e-496f-bebd-9ee7067bcdb2 | 2025-11-19 | Warnings | M004 |
| dabur First Aid | BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE | Dabur India Limited | 229170a3-ef9e-597d-e063-6394a90acf8b | 2025-11-18 | Warnings | M004 |
| QS Plus Instant Hand Sanitizer | BENZEALKONIUM CHLORIDE | Romaine Companies | 5e16f52d-3bf3-4897-bd3a-cf4e117583c9 | 2025-11-18 | Warnings | M004 |
| Hand Guard Foaming Instant Hand Sanitizer | ALCOHOL | Wechem, Inc. | d9b89f90-aece-48a2-862a-c524d3c90841 | 2025-11-18 | Warnings | M004 |
| Puri-San Plus Instant Hand Sanitizer | BENZEALKONIUM CHLORIDE | People's Janitorial Supply | f0726bdd-9d2b-4383-af10-e2e0c5460e1e | 2025-11-18 | Warnings | M004 |
| Lynx san a foam | ALCOHOL | ABC Compounding Co., Inc. | 2b987ebc-c73b-edbd-e063-6394a90a1d2d | 2025-11-18 | Warnings | M004 |
| Instant Hand Sanitizer | ALCOHOL | ABC Compounding Co., Inc. | ee46cb57-c79c-4edf-bc88-4a4f8a95bfc8 | 2025-11-18 | Warnings | M004 |
| Rapidol Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Pharmadel LLC | 1ad22205-f8c3-b142-e063-6394a90a0044 | 2025-11-17 | Warnings | M004 |
| Bacitracin | BACITRACIN | Kroger | 3f860e7f-487b-d706-e063-6394a90a73ad | 2025-11-13 | Warnings | M004 |
| ElixirBaciShield First Aid | BACITRACIN ZINC | ELIXIR HEALTHCARE USA, LLC. | 15e31a2a-01b5-4598-850f-4d0348086b4b | 2025-11-12 | Warnings | M004 |
| Bacitracin Zinc | BACITRACIN ZINC | Trifecta Pharmaceuticals USA LLC | 4352c453-a89c-a2b9-e063-6294a90a61f3 | 2025-11-11 | Warnings | M004 |
| Bacitracin Zinc | BACITRACIN ZINC | Universal Distribution Center LLC | 186b2750-5bf6-1702-e063-6294a90a62b3 | 2025-10-30 | Warnings | M004 |
| POMADA SULFA FIRST AID ANTIBIOTIC | NEOMYCIN SULFATE | GRANDALL DISTRIBUTING, LLC | 1d8e1fca-6864-7c08-e063-6394a90a08b6 | 2025-10-28 | Warnings | M004 |
| POLVO DE SULFA FIRST AID ANTIBIOTIC | BACITRACIN ZINC, POLYMYXIN B SULFATE | GRANDALL DISTRIBUTING, LLC | 1d8e3a03-a39f-a99e-e063-6394a90a31db | 2025-10-28 | Warnings | M004 |
| EasyTouch Alcohol Prep Pads Sterile | ISOPROPYL ALCOHOL | MHC Medical Products, LLC | fd60ad34-5fd9-4440-9f3f-23beffc19dd9 | 2025-10-24 | 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 | 7c0d3cdf-af50-4a65-a01b-a33510feeb94 | 3 |
| 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 | 7c0d3cdf-af50-4a65-a01b-a33510feeb94 | 3 |
| 2055751 | bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT / pramoxine HCl 10 MG per GM Topical Ointment | SY | 7c0d3cdf-af50-4a65-a01b-a33510feeb94 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69729-616-01 | 69729061601 | 14 g in 1 TUBE | 14 g | Historical | ||||
| 69729-616-61 | 69729061661 | 1 TUBE in 1 BOX (69729-616-61) / 14 g in 1 TUBE (69729-616-01) | 1 tube | 2018-09-05 | 0000-00-00 | No | No | Current |