Polvos de Sulpha
- Product NDC
- 53145-304
- 11-digit product format
- 531450304
- Labeler code
- 53145
- Product ID
- 53145-304_2b362c67-d115-fb81-e063-6394a90aeb65
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Bacitracin Zinc, Polymyxin B Sulfate
- Dosage form
- POWDER
- Route
- TOPICAL
- Labeler
- Menper Distributors Inc.
- Application
- M004
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2006-12-11
- Substance
- BACITRACIN ZINC; POLYMYXIN B SULFATE
- Active strength
- 500; 10000 [USP'U]/g; [USP'U]/g
- Pharmacologic classes
- 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 product | product | 53145-304 | I | Inactivated by FDA | 2026-08-10 | ||
| excluded package | package | 53145-304 | 53145-304-04 | I | Inactivated by FDA | 2026-08-10 |
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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 53145-304-04 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 53145-304-04 | E | Excluded after deficient or non-compliant submission was not corrected | 110d247fa046… | a55b01930146… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 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 |
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2023-10-19 | Polvos de Sulpha |
| 2023-07-28 | Polvos de Sulpha |
| 2022-02-18 | Polvos de Sulpha |
| 2022-01-28 | Polvos de Sulpha |
| 2020-02-07 | Polvos de Sulpha |
| 2020-01-31 | Polvos de Sulpha |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53145-304-04 | Polvos de SulphaFirst Aid Antibiotic | 7.5 g in 1 BOTTLE, PLASTIC | POWDER | 7.5 | 12 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| BACITRACIN ZINC | ACTIVE INGREDIENT | 89Y4M234ES | POLVOS DE SULPHA FIRST AID ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE) POWDER [MENPER DISTRIBUTORS INC.] | 4 | |
| POLYMYXIN B SULFATE | ACTIVE INGREDIENT | 19371312D4 | POLVOS DE SULPHA FIRST AID ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE) POWDER [MENPER DISTRIBUTORS INC.] | 4 | |
| BACITRACIN ZINC | ACTIVE MOIETY | 89Y4M234ES | POLVOS DE SULPHA FIRST AID ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE) POWDER [MENPER DISTRIBUTORS INC.] | 4 | |
| POLYMYXIN B | ACTIVE MOIETY | J2VZ07J96K | POLVOS DE SULPHA FIRST AID ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE) POWDER [MENPER DISTRIBUTORS INC.] | 4 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | POLVOS DE SULPHA FIRST AID ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE) POWDER [MENPER DISTRIBUTORS INC.] | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53145-304 | POLVOS DE SULPHA FIRST AID ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE) POWDER [MENPER DISTRIBUTORS INC.] | 12 | Current NDC, Legacy NDC, 1 package rows | 20250116_511b52e9-c112-4519-a567-dc9f433c4f37.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 |
|---|---|---|---|---|---|---|
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE | Salado Sales, Inc | 52e275d3-88c9-47f1-8dcf-68445c7be4a7 | 2026-08-05 | Warnings | M004 |
| Wound Wash Antiseptic Saline with Benzalkonium Chloride | WOUND WASH ANTISEPTIC SALINE WITH BENZALKONIUM CHLORIDE | NeilMed Pharmaceuticals, Inc. | 55a1fc63-2527-4033-e054-00144ff8d46c | 2026-08-05 | Warnings | M004 |
| ProcureTriple Antibiotic Triple Antibiotic | BACITRACIN ZINC NEOMYCIN SULFATE POLYMYXIN B | TWIN MED, LLC | 71592776-407b-489c-8cdb-8c0573d844f8 | 2026-08-03 | Warnings | M004 |
| procureFirst Aid Antibio First Aid Antibiotic | BACITRACIN | TWIN MED, LLC | 8d19e931-99c4-47b8-b7ec-94c16535166f | 2026-08-03 | Warnings | M004 |
| TRIPLE ANTIBIOTIC | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Vive Health LLC | 236c62bf-3de0-0b3e-e063-6394a90ad6c6 | 2026-07-21 | Warnings | M004 |
| TRIPLE ANTIBIOTIC | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Vive Health LLC | 21b38b00-1e64-83d8-e063-6294a90a07bd | 2026-07-21 | Warnings | M004 |
| DERMFREE Triple Antibiotic | TRIPLE ANTIBIOTIC | Jiangxi Yudexi Pharmaceutical Co., LTD | 4a5a5603-3478-5f7a-e063-6294a90acc40 | 2026-07-21 | Warnings | M004 |
| Bacitracin | BACITRACIN ZINC | Preferred Pharmaceuticals Inc. | e094566b-3b80-45ac-be73-54c798bbb763 | 2026-07-15 | Warnings | M004 |
| CAREALL Bacitracin | BACITRACIN ZINC | New World Imports, Inc | 560ba2ca-ad0f-9202-e063-6294a90aaefd | 2026-07-14 | Warnings | M004 |
| CareALL Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | New World Imports, Inc | 561bf89c-ca78-d7e4-e063-6394a90a983f | 2026-07-14 | Warnings | M004 |
| Good Sense First Aid Antibiotic | BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B | L. Perrigo Company | 3eadd35c-3df2-4e46-b76d-a6e537895917 | 2026-07-10 | Warnings | M004 |
| CareALL Triple Antibiotic plus Pain Relief | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCL | New World Imports, Inc | 561c1e51-19f4-90ce-e063-6294a90a5f9b | 2026-07-08 | Warnings | M004 |
| Ever Ready First Aid Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | EVER READY FIRST AID | ee1ad6d7-e9c1-2b20-e053-2995a90a3366 | 2026-07-03 | Warnings | M004 |
| Single Antibiotic with bacitracin | BACITRACIN ZINC | Safetec of America | 4ae9a105-e3f9-4015-8844-085e0b34cdb6 | 2026-06-25 | Warnings | M004 |
| Antibacterial Hand Wipes (0.13% Benzalkonium Chloride) | BENZALKONIUM CHLORIDE | Eleeo Brands LLC | 551baf59-39b9-e994-e063-6294a90a65e6 | 2026-06-25 | Warnings | M004 |
| Medi First Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Unifirst First Aid Corporation | 545fa5b6-781c-18ae-e063-6294a90a2f0d | 2026-06-16 | Warnings | M004 |
| Triple Antibiotic | FIRST AID ANTIBIOTIC ORIGINAL STRENGTH | Aldermed Inc. | 19eace87-b505-4be6-93b3-db5323e34216 | 2026-06-12 | Warnings | M004 |
| Bacitracin | BACITRACIN | AlderMed Inc. | 3f0eb4a0-f7bf-45f7-8885-92c65a4bd899 | 2026-06-08 | Warnings | M004 |
| Bacitracin Zinc | FIRST AID ANTIBIOTIC | Aldermed Inc. | 7f4bff4f-588d-4e45-8aa3-f95b4d746f25 | 2026-06-08 | Warnings | M004 |
| Triple Antibiotic First Aid Antibiotic plus Pain Relief | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HCL | Aldermed Inc. | 5bfc7776-1030-48ba-9df4-897c4984c9e6 | 2026-06-08 | Warnings | M004 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 308513 | bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical Powder | PSN | 511b52e9-c112-4519-a567-dc9f433c4f37 | 12 |
| 308513 | bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Topical Powder | SCD | 511b52e9-c112-4519-a567-dc9f433c4f37 | 12 |
| 308513 | bacitracin 500 UNT/GM / polymyxin B 10,000 UNT/GM Topical Powder | SY | 511b52e9-c112-4519-a567-dc9f433c4f37 | 12 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53145-304-04 | 53145030404 | 7.5 g in 1 BOTTLE, PLASTIC (53145-304-04) | 7.5 g | 2006-12-11 | 0000-00-00 | No | No | Current |