Triple Antibiotic
- Product NDC
- 47682-392
- 11-digit product format
- 476820392
- Labeler code
- 47682
- Product ID
- 47682-392_3e4ee639-9af3-38c5-e063-6394a90a9ad3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- bacitracin zinc, neomycin sulfate, polymyxin b sulfate
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Unifirst First Aid Corporation
- Application
- M004
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2013-04-12
- Substance
- BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
- Active strength
- 400; 3.5; 5000 [USP'U]/g; mg/g; [USP'U]/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
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 47682-392 | 47682-392-12 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 47682-392 | 47682-392-71 | D | Discontinued by firm | 2026-10-15 |
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 | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | 47682-392-12 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 47682-392-71 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 47682-392-71 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 47682-392-12 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 47682-392-71 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 47682-392-12 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 47682-392-71 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 47682-392-12 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 47682-392-71 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 47682-392-12 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 47682-392-71 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 47682-392-12 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 47682-392-71 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 47682-392-12 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 47682-392-71 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 47682-392-12 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 47682-392-71 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 47682-392-12 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 47682-392-71 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 47682-392-12 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 47682-392-71 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 47682-392-12 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 47682-392-71 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 47682-392-12 | 557ba5c1ecfa… | 9c80585c8c6e… |
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
- Triple Antibiotic
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BACITRACIN ZINC | 400 [USP'U]/g |
| NEOMYCIN SULFATE | 3.5 mg/g |
| POLYMYXIN B SULFATE | 5000 [USP'U]/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 |
|---|---|
| d7c1a10e-c38d-4ae8-9a27-c07c2208ca84 | 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 47682-392-12 | Triple Antibiotic | 0.5 g in 1 PACKET | OINTMENT | 0.5 | 14 | |
| 47682-392-12 | Triple Antibiotic | 10 in 1 BOX | OINTMENT | 10 | 14 | |
| 47682-392-35 | Triple Antibiotic | 0.5 g in 1 PACKET | OINTMENT | 0.5 | 14 | |
| 47682-392-35 | Triple Antibiotic | 144 in 1 BAG | OINTMENT | 144 | 14 | |
| 47682-392-71 | Triple Antibiotic | 0.5 g in 1 PACKET | OINTMENT | 0.5 | 14 | |
| 47682-392-71 | Triple Antibiotic | 20 in 1 BOX | OINTMENT | 20 | 14 | |
| 47682-392-73 | Triple Antibiotic | 25 in 1 BOX, UNIT-DOSE | OINTMENT | 25 | 14 | |
| 47682-392-99 | Triple Antibiotic | 0.5 g in 1 PACKET | OINTMENT | 0.5 | 14 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 47682-392 | TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE) OINTMENT [UNIFIRST FIRST AID CORPORATION] | 13 | Current NDC, Legacy NDC, 8 package rows | 20250210_d7c1a10e-c38d-4ae8-9a27-c07c2208ca84.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 |
|---|---|---|---|---|---|---|
| Leader Bacitracin Zinc | BACITRACIN ZINC | Cardinal Health 110 dba LEADER | a353dce2-8ae5-23aa-e053-2a95a90a89c2 | 2024-01-02 | Warnings | M004 |
| Triple Antibiotic | POLYMYXIN B SULFATE, BACITRACIN ZINC AND NEOMYCIN SULFATE | NuCare Pharmaceuticals,Inc. | 0dfe5f6a-6968-68e6-e063-6294a90ae25b | 2024-01-02 | Warnings | M004 |
| Bacitracin | BACITRACIN | Proficient Rx LP | e1166948-5d80-44c2-a20d-78be631647d9 | 2024-01-01 | Warnings | M004 |
| TRIPLE ANTIBIOTIC | BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B SULFATE | Proficient Rx LP | 949c5b44-ee52-4913-8872-39181d319998 | 2024-01-01 | Warnings | M004 |
| Triple Antibiotic Plus | POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, PRAMOXINE HCL | Cosette Pharmaceuticals, Inc. | 69d911c2-cb89-2241-35f8-c83acfe18249 | 2023-12-21 | Warnings | M004 |
| Bacitracin | BACITRACIN | Cosette Pharmaceuticals, Inc. | 630e0841-baf2-e9fa-b309-ad1a5f95da3b | 2023-12-20 | Warnings | M004 |
| Triple Antibiotic | POLYMYXIN B SULFATE, BACITRACIN ZINC AND NEOMYCIN SULFATE | Cosette Pharmaceuticals, Inc. | 39893365-c94f-bc83-67f6-0005d5f2aa24 | 2023-12-20 | Warnings | M004 |
| Triple Antibiotic | POLYMYXIN B SULFATE, BACITRACIN ZINC AND NEOMYCIN SULFATE | Proficient Rx LP | 524d65e7-9dc6-47b0-a924-46a765fa1869 | 2023-12-01 | Warnings | M004 |
| Viabecline | TETRACYCLINE HYDROCHLORIDE | Accuria, LLC | 9fd7041a-6c23-4332-90fe-759bb4aea2ae | 2023-12-01 | Warnings | M004 |
| Bacitracin | BACITRACIN | Proficient Rx LP | 65f8fd49-1882-4eac-9c0e-d63968da33d4 | 2023-12-01 | Warnings | M004 |
| Genuine First Aid Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | GFA Production(Xiamen) Co.,Ltd | 0aaee474-cf35-8b39-e063-6294a90a815c | 2023-11-21 | Warnings | M004 |
| Sheffield Bacitracin Zinc | BACITRACIN ZINC | Sheffield Pharmaceuticals LLC | 0f446f48-f55d-4de7-b447-285d7a329c84 | 2023-11-20 | Warnings | M004 |
| Sheffield Triple Antibiotic Plus Pain Relief | BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDE | Sheffield Pharmaceuticals LLC | 485a779c-017b-4064-a446-e5073c1bdb07 | 2023-11-20 | Warnings | M004 |
| Bacitracin | BACITRACIN | BluePoint Laboratories | b4d8ef06-6269-68f7-e053-2995a90ac8ea | 2023-11-17 | Warnings | M004 |
| Bacitracin Zinc | FIRST AID ANTIBIOTIC | BluePoint Laboratories | d914abe1-5e14-5673-e053-2a95a90ac91b | 2023-11-17 | Warnings | M004 |
| EVERLIT CARE Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | EVERLIT GLOBAL INC. | e9157891-fc05-41a1-8a86-761a9ae56f8a | 2023-11-14 | Warnings | M004 |
| CR-371059 Tolnaftate 1% | CR-371059 TOLNAFTATE 1% | A-S Medication Solutions | bb4e4612-850c-4863-954d-7ad0500b9c05 | 2023-11-01 | Warnings | M004 |
| Isopropyl Alcohol | ISOPROPYL ALCOHOL | A-S Medication Solutions | b44b07a0-91ff-476a-ae0a-080fa0191777 | 2023-10-31 | Warnings | M004 |
| Family wellness | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | FRONT PHARMACEUTICAL PLC | bd3b8146-6271-488d-bf79-0bb659123b31 | 2023-10-27 | Warnings | M004 |
| Family Wellness | BACITRACIN ZINC | FRONT PHARMACEUTICAL PLC | dfc148c1-d1bb-4230-b8cf-9457b99d4e8a | 2023-10-27 | 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 | d7c1a10e-c38d-4ae8-9a27-c07c2208ca84 | 14 |
| 204602 | bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical Ointment | SCD | d7c1a10e-c38d-4ae8-9a27-c07c2208ca84 | 14 |
| 204602 | bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical Ointment | SY | d7c1a10e-c38d-4ae8-9a27-c07c2208ca84 | 14 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 47682-392-12 | 47682039212 | 0.5 g in 1 PACKET | 0.5 g | Historical | ||||
| 47682-392-35 | 47682039235 | 144 PACKET in 1 BAG (47682-392-35) / .5 g in 1 PACKET | 144 packet | 2017-06-30 | 0000-00-00 | No | No | Current |
| 47682-392-71 | 47682039271 | 0.5 g in 1 PACKET | 0.5 g | Historical | ||||
| 47682-392-73 | 47682039273 | 25 PACKET in 1 BOX, UNIT-DOSE (47682-392-73) / .5 g in 1 PACKET (47682-392-99) | 25 packet | 2016-06-06 | 0000-00-00 | No | No | Current |
| 47682-392-99 | 47682039299 | .5 g in 1 PACKET (47682-392-99) | 2013-04-12 | No | No | Current |