Sheffield Triple Antibiotic
- Product NDC
- 11527-162
- 11-digit product format
- 115270162
- Labeler code
- 11527
- Product ID
- 11527-162_e78cd65b-8aeb-4fc5-8551-2deceb5d01e2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Bacitracin Zinc, Polymyxin B Sulfate, Neomycin Sulfate
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Sheffield Pharmaceuticals LLC
- Application
- M004
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2011-01-23
- Substance
- BACITRACIN ZINC; POLYMYXIN B SULFATE; NEOMYCIN SULFATE
- Active strength
- 400; 5000; 3.5 [USP'U]/g; [USP'U]/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
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 | 11527-162 | 11527-162-27 | D | Discontinued by firm | 2026-10-15 | |
| excluded package | package | 11527-162 | 11527-162-30 | 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 | 11527-162-27 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 11527-162-30 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 11527-162-27 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 11527-162-30 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 11527-162-27 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 11527-162-30 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 11527-162-27 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 11527-162-30 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 11527-162-27 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 11527-162-30 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 11527-162-27 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 11527-162-30 | cdf11ea48f46… | ba0047e9e063… |
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
- Sheffield Triple Antibiotic
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BACITRACIN ZINC | 400 [USP'U]/g |
| POLYMYXIN B SULFATE | 5000 [USP'U]/g |
| NEOMYCIN SULFATE | 3.5 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 89Y4M234ES | Internal UNII lookup |
| 19371312D4 | Internal UNII lookup |
| 057Y626693 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 204602 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1aa95046-c1f7-4fc7-acac-839065d998f6 | 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 |
|---|---|---|---|---|---|---|
| 11527-162-27 | Sheffield Triple Antibiotic | 144 in 1 CARTON | OINTMENT | 144 | 6 | |
| 11527-162-27 | Sheffield Triple Antibiotic | 0.9 g in 1 PACKET | OINTMENT | 0.9 | 6 | |
| 11527-162-30 | Sheffield Triple Antibiotic | 30 g in 1 TUBE | OINTMENT | 30 | 6 | |
| 11527-162-30 | Sheffield Triple Antibiotic | 1 in 1 CARTON | OINTMENT | 1 | 6 | |
| 11527-162-47 | Sheffield Triple Antibiotic | 9.35 g in 1 TUBE | OINTMENT | 9.35 | 6 | |
| 11527-162-47 | Sheffield Triple Antibiotic | 1 in 1 CARTON | OINTMENT | 1 | 6 | |
| 11527-162-51 | Sheffield Triple Antibiotic | 1 in 1 CARTON | OINTMENT | 1 | 6 | |
| 11527-162-51 | Sheffield Triple Antibiotic | 14 g in 1 TUBE | OINTMENT | 14 | 6 | |
| 11527-162-55 | Sheffield Triple Antibiotic | 1 in 1 CARTON | OINTMENT | 1 | 6 | |
| 11527-162-55 | Sheffield Triple Antibiotic | 28 g in 1 TUBE | OINTMENT | 28 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 11527-162-47 | GM - Gram | 11527-162 | 6c6c7bbc-a101-4ce7-bc52-1951b48d42d8 | 1 | 2021-06-02 |
| 11527-162-51 | GM - Gram | 11527-162 | ba250ba0-cb97-49dd-aae5-a6abb1e40fa2 | 1 | 2021-06-02 |
| 11527-162-55 | GM - Gram | 11527-162 | 846db55e-4ed6-4258-805b-60b34cd648cf | 1 | 2021-06-02 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 11527-162 | SHEFFIELD TRIPLE ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE) OINTMENT [SHEFFIELD PHARMACEUTICALS LLC] | 6 | Current NDC, Legacy NDC, 10 package rows | 20250221_1aa95046-c1f7-4fc7-acac-839065d998f6.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 |
|---|---|---|---|---|---|---|
| First Aid Antibiotic | BACITRACIN ZINC | TARGET Corporation | 4d8e7146-9215-417e-93be-af706502cfee | 2025-07-07 | Warnings | M004 |
| TRIPLE ANTIBIOTIC PLUS PAIN RELIEF | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE | GENOMMA LAB USA, INC. | 506fcda5-df44-49c8-8dbd-cab7434b06b2 | 2025-07-02 | Warnings | M004 |
| DG Poly Antibiotic First Aid Antibiotic | BACITRACIN AND POLYMYXIN B SULFATE | Dollar General | 4d710928-5a7d-4f1a-aea0-be7fe599ae0c | 2025-07-02 | Warnings | M004 |
| Curad Maximum Strength Triple Antibiotic | BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE | Medline Industries, LP | 99e9c394-ebf1-7a27-e053-2a95a90ab157 | 2025-07-01 | Warnings | M004 |
| Double Antibiotic | BACITRACIN ZINC AND POLYMYXIN B SULFATE | Sun Pharmaceutical Industries, Inc. | 7e8af528-eb25-4f93-9b35-8fff635932cc | 2025-07-01 | Warnings | M004 |
| Triple Antibiotic plus Pain Relief Maximum Strength | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND PRAMOXINE HYDROCHLORIDE | Chain Drug Consortium, LLC | 55ef2205-aaf1-4aa4-917f-2b4cfa43b77e | 2025-07-01 | Warnings | M004 |
| Bacitracin | BACITRACIN | RUGBY LABORATORIES | aa9f414e-d8de-417d-9ccd-027d5a5f5499 | 2025-06-27 | Warnings | M004 |
| Meret Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Nantong Health & Beyond Hygienic Products Inc. | 385d8642-9eae-a750-e063-6394a90a7931 | 2025-06-24 | Warnings | M004 |
| ProCure Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Twin Med LLC | 37a3916f-cc1a-41a0-e063-6394a90a35ed | 2025-06-16 | Warnings | M004 |
| Bacitracin Zinc | FIRST AID ANTIBIOTIC | Dynarex Corporation | 82cf8dd0-eef6-5871-e053-2991aa0a38cf | 2025-06-16 | Warnings | M004 |
| Sion Biotext Bacitracin Zinc | BACITRACIN ZINC | Sion Biotext Medical Ltd | 35056345-f325-99e8-e063-6294a90a2d7e | 2025-06-12 | Warnings | M004 |
| ProCure Bacitracin Zinc | BACITRACIN ZINC | Twin Med LLC | 36da7993-7c65-7430-e063-6294a90a0626 | 2025-06-05 | Warnings | M004 |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, POLYMYXIN B | J&A Digital Inc. | 9b8f2046-5886-440d-a7fc-a71138d7f34b | 2025-06-02 | Warnings | M004 |
| Lights Povidone Iodine Scrub | POVIDONE-IODINE | Lights Medical Manufacture Co., Ltd. | 5e1eef53-c2c7-477e-9ee4-19c01c1881e5 | 2025-05-20 | Warnings | M004 |
| Bacitracin | BACITRACIN ZINC | Trifecta Pharmaceuticals USA, LLC. | 4a9fe0fa-5549-4e06-e054-00144ff8d46c | 2025-05-15 | Warnings | M004 |
| SionBiotext Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Sion Biotext Medical Ltd | 35083d42-5823-eeb1-e063-6294a90acafa | 2025-05-13 | Warnings | M004 |
| Multi Action | BACITRACINZINC,NEOMYCINSULFATE,POLYMYXINBSULFATE,PRAMOXINEHCL | Trifecta Pharmaceutical USA LLC | b98082f3-be95-49fb-e053-2a95a90a37b8 | 2025-05-13 | Warnings | M004 |
| Leader Triple antibiotic and pain relief | BACITRACIN,NEOMYCIN,POLYMXIN, PRAMOXINE | Cardinal Health 110 dba LEADER | f4c521d9-dd05-1c23-e053-2995a90a6e2c | 2025-05-13 | Warnings | M004 |
| Tripleantibioticointmentandpainrelief | BACITRACIN,NEOMYCIN,POLYMXIN, PRAMOXINE | Trifecta Pharmaceuticals USA | 34f1db74-6506-d53d-e063-6394a90ac400 | 2025-05-12 | Warnings | M004 |
| Triple Antibiotic plus Lidocaine | BACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE, LIDOCAINE | TRIFECTA PHARMACEUTICALS USA LLC | 14fda967-54ba-c964-e063-6294a90a21ee | 2025-04-24 | 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 | 1aa95046-c1f7-4fc7-acac-839065d998f6 | 6 |
| 204602 | bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical Ointment | SCD | 1aa95046-c1f7-4fc7-acac-839065d998f6 | 6 |
| 204602 | bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical Ointment | SY | 1aa95046-c1f7-4fc7-acac-839065d998f6 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 11527-162-27 | 11527016227 | 144 PACKET in 1 CARTON (11527-162-27) > .9 g in 1 PACKET | 144 packet | 2018-10-12 | 0000-00-00 | No | No | Current |
| 11527-162-30 | 11527016230 | 1 TUBE in 1 CARTON (11527-162-30) > 30 g in 1 TUBE | 1 tube | 2020-12-22 | 0000-00-00 | No | No | Current |
| 11527-162-47 | 11527016247 | 1 TUBE in 1 CARTON (11527-162-47) / 9.35 g in 1 TUBE | 1 tube | 2011-01-23 | 0000-00-00 | No | No | Current |
| 11527-162-51 | 11527016251 | 1 TUBE in 1 CARTON (11527-162-51) / 14 g in 1 TUBE | 1 tube | 2011-01-23 | 0000-00-00 | No | No | Current |
| 11527-162-55 | 11527016255 | 1 TUBE in 1 CARTON (11527-162-55) / 28 g in 1 TUBE | 1 tube | 2012-11-09 | 0000-00-00 | No | No | Current |