Triple Antibiotic
- Product NDC
- 0713-0268
- 11-digit product format
- 007130268
- Labeler code
- 0713
- Product ID
- 0713-0268_0cf1cf3a-c318-a32a-e063-6394a90a884d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Polymyxin B Sulfate, Bacitracin Zinc and Neomycin Sulfate
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Cosette Pharmaceuticals, Inc.
- Application
- M004
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 1995-01-11
- 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
Observed NDC auxiliary status history#
Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | 0713-0268 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 86f5da6cb304… | a595104c45d7… | ||
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 0713-0268 | 0713-0268-31 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | 0713-0268 | I | Inactivated by FDA | excluded / ndc_excluded.zip | bd6a592717d7… | 303034d00443… | ||
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 0713-0268 | 0713-0268-31 | I | Inactivated by FDA | excluded / ndc_excluded.zip | bd6a592717d7… | 303034d00443… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | 0713-0268 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 8dfbde2a14a4… | c9ff85d89658… | ||
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 0713-0268 | 0713-0268-31 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 8dfbde2a14a4… | c9ff85d89658… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | 0713-0268 | I | Inactivated by FDA | excluded / ndc_excluded.zip | e2bbac7714bc… | 27bdfed8d636… | ||
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 0713-0268 | 0713-0268-31 | I | Inactivated by FDA | excluded / ndc_excluded.zip | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | 0713-0268 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 9bebd1f3094a… | 5416666fcb17… | ||
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 0713-0268 | 0713-0268-31 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 9bebd1f3094a… | 5416666fcb17… | |
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded product | product | 0713-0268 | E | Excluded after deficient or non-compliant submission was not corrected | excluded / ndc_excluded.zip | 110d247fa046… | a55b01930146… | ||
| 2019-12-08 06:16 UTC · source 2019-12-05 | excluded package | package | 0713-0268 | 0713-0268-31 | E | Excluded after deficient or non-compliant submission was not corrected | excluded / ndc_excluded.zip | 110d247fa046… | a55b01930146… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 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 |
| Good Sense First Aid Antibiotic | BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B | L. Perrigo Company | 3eadd35c-3df2-4e46-b76d-a6e537895917 | 2026-07-10 | 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 |
| Triple Antibiotic Plus Pain Relief | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | 4545c043-8e8e-4288-b4d8-e6ec9d72f979 | 2026-06-04 | Warnings | M004 |
| First Aid Kit, Orazen Inc | 5 ADHESIVE BANDAGES, 2 ANTIBIOTIC OINTMENTS | Orazen Inc | 525bcb89-af5b-8652-e063-6294a90a41a6 | 2026-06-03 | Warnings | M004 |
| Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATE | Sun Pharmaceutical Industries, Inc. | d77239e6-5e81-439a-b0cd-f8be59169442 | 2026-06-02 | Warnings | M004 |
| First Aid Antibiotic | BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B | HyVee Inc | 3ac9f0fc-e08c-49d9-9079-3ba0393c612b | 2026-06-02 | Warnings | M004 |
| Triple Antibiotic Plus Pain Relief | BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL | HyVee Inc | 69a4b642-b7ec-43cc-aa57-6858da0b3d63 | 2026-06-02 | Warnings | M004 |
| Careland Triple Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Planet (Anhui) Pharmaceutical Co., Ltd. | 0e64179d-fce2-48fc-833e-ce43a54b987c | 2026-05-31 | Warnings | M004 |
| First Aid Antibiotic | BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE | Hubei Fanjian Medical Product Co.,Ltd | f44ab989-c618-1831-e053-2995a90adc8e | 2026-05-28 | Warnings | M004 |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Triple Antibiotic
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| POLYMYXIN B SULFATE | 400 [USP'U]/g |
| NEOMYCIN SULFATE | 3.5 mg/g |
| BACITRACIN ZINC | 5000 [USP'U]/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 19371312D4 | Internal UNII lookup |
| 057Y626693 | Internal UNII lookup |
| 89Y4M234ES | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 204602 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 39893365-c94f-bc83-67f6-0005d5f2aa24 | 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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0713-0268-31 | 2022-08-19 | C162847 | 48780-1 | 9d75b9d1-0873-f424-e053-dadaa90a57ce | Triple Antibiotic Ointment First Aid Antibiotic Ointment |
| 0713-0268-31 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d1-0873-f424-e053-dadaa90a57ce | Triple Antibiotic Ointment First Aid Antibiotic Ointment |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0713-0268-31 | Triple Antibiotic | 28.4 g in 1 TUBE | OINTMENT | 28.4 | 3 | |
| 0713-0268-31 | Triple Antibiotic | 1 in 1 CARTON | OINTMENT | 1 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0713-0268-31 | GM - Gram | 0713-0268 | 11922163-2c1a-4c42-8a3d-cbcd9eda8e95 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0713-0268 | TRIPLE ANTIBIOTIC (POLYMYXIN B SULFATE, BACITRACIN ZINC AND NEOMYCIN SULFATE) OINTMENT [COSETTE PHARMACEUTICALS, INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20231221_39893365-c94f-bc83-67f6-0005d5f2aa24.zip |
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 | e115d413-e41c-4e43-8184-493d64dfcd9f | 16 |
| 204602 | bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical Ointment | SCD | e115d413-e41c-4e43-8184-493d64dfcd9f | 16 |
| 204602 | bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical Ointment | SY | e115d413-e41c-4e43-8184-493d64dfcd9f | 16 |
| 204602 | bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical Ointment | PSN | 39893365-c94f-bc83-67f6-0005d5f2aa24 | 3 |
| 204602 | bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical Ointment | SCD | 39893365-c94f-bc83-67f6-0005d5f2aa24 | 3 |
| 204602 | bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical Ointment | SY | 39893365-c94f-bc83-67f6-0005d5f2aa24 | 3 |
| 204602 | bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical Ointment | PSN | 524d65e7-9dc6-47b0-a924-46a765fa1869 | 2 |
| 204602 | bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical Ointment | SCD | 524d65e7-9dc6-47b0-a924-46a765fa1869 | 2 |
| 204602 | bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical Ointment | SY | 524d65e7-9dc6-47b0-a924-46a765fa1869 | 2 |
| 204602 | bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical Ointment | PSN | 0dfe5f6a-6968-68e6-e063-6294a90ae25b | 1 |
| 204602 | bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical Ointment | SCD | 0dfe5f6a-6968-68e6-e063-6294a90ae25b | 1 |
| 204602 | bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical Ointment | SY | 0dfe5f6a-6968-68e6-e063-6294a90ae25b | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0713-0268-31 | 00713026831 | 1 TUBE in 1 CARTON (0713-0268-31) / 28.4 g in 1 TUBE | 1 tube | 1995-01-11 | 0000-00-00 | No | No | Current |