Indications and uses
For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to bacitracin zinc and polymyxin B sulfate.
Bacitracin Zinc and Polymyxin B Sulfate
- Manufacturer
- RPK Pharmaceuticals, Inc.
- Effective date
- 2023-06-07
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-05-31 20:50:17
Label at a glance#
ProductBacitracin Zinc and Polymyxin B Sulfate
Active ingredientBACITRACIN ZINC, POLYMYXIN B SULFATE
Label structure10 sections
Dosage and administration
Apply the ointment every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection. FOR OPHTHALMIC USE ONLY
Contacts and useful links#
Websitewww.fda.gov
www.fda.gov/medwatch
www.fda.gov/medwatchLabel contents#
Full prescribing information#
DESCRIPTION
Bacitracin zinc and polymyxin B sulfate ophthalmic ointment, USP is a sterile antimicrobial ointment formulated for ophthalmic use.
Bacitracin zinc is the zinc salt of bacitracin, a mixture of related cyclic polypeptides (mainly bacitracin A) produced by the growth of an organism of the licheniformis group of Bacillus subtilis var Tracy. It has a potency of not less than 40 bacitracin units/mg. The structural formula for bacitracin A is:
Polymyxin B sulfate is the sulfate salt of polymyxin B1 and B2, which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units/mg, calculated on an anhydrous basis. The structural formulae are:
Each gram contains: Actives: bacitracin zinc equal to 500 bacitracin units and polymyxin B sulfate equal to 10,000 polymyxin B units; Inactives: mineral oil and white petrolatum.
CLINICAL PHARMACOLOGY
Polymyxin B sulfate attacks gram-negative bacilli, including virtually all strains of Pseudomonas aeruginosa and Haemophilus influenzae species.
Bacitracin is active against most gram-positive bacilli and cocci including hemolytic streptococci.
INDICATIONS AND USAGE
For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to bacitracin zinc and polymyxin B sulfate.
CONTRAINDICATIONS
This product is contraindicated in those individuals who have shown hypersensitivity to any of its components.
WARNINGS
Ophthalmic ointments may retard corneal healing.
PRECAUTIONS
As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. Appropriate measures should be taken if this occurs.
ADVERSE REACTIONS
To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DOSAGE AND ADMINISTRATION
Apply the ointment every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection.
FOR OPHTHALMIC USE ONLY
HOW SUPPLIED
Product: 53002-9271
NDC: 53002-9271-1 3.5 g in a BOTTLE, DROPPER
Bacitracin/Poly-B Ophthalmic Ointment
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 308511 | bacitracin zinc 500 UNT / polymyxin B sulfate 10,000 UNT per GM Ophthalmic Ointment | PSN | 3 |
| 308511 | bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Ophthalmic Ointment | SCD | 3 |
| 308511 | bacitracin (as bacitracin zinc) 500 UNT / polymyxin B (as polymyxin B sulfate) 10,000 UNT per GM Ophthalmic Ointment | SY | 3 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| BACITRACIN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| POLYMYXIN B Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
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#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53002-9271-1 | 2025-01-30 | C162847 | 48780-1 | f386c649-e6bf-0266-e053-dadaa90a7c1a | Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment, USP (Sterile) Rx only |
| 53002-9271-1 | 2023-06-07 | C162847 | 48780-1 | f386c649-e6bf-0266-e053-dadaa90a7c1a | Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment, USP (Sterile) Rx only |
| 53002-9271-1 | 2023-01-30 | C162847 | 48780-1 | f386c649-e6bf-0266-e053-dadaa90a7c1a | Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment, USP (Sterile) Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53002-9271-1 | Bacitracin Zinc and Polymyxin B Sulfate | 3.5 g in 1 BOTTLE, DROPPER | OINTMENT | 3.5 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53002-9271 | BACITRACIN ZINC AND POLYMYXIN B SULFATE OINTMENT [RPK PHARMACEUTICALS, INC.] | 3 | Legacy NDC, 1 package rows | 20230609_51c5b733-ee9d-4f34-bdc6-38c837e0dee8.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 24208-555-55 | GM - Gram | 24208-555 | c57667c9-6de6-4089-b985-888973dbfd11 | 1 | 2012-07-24 |
Products#
Every source-derived product name is available through these pages.
- Bacitracin Zinc and Polymyxin B Sulfate
- BACITRACIN ZINC
- BACITRACIN
- POLYMYXIN B SULFATE
- POLYMYXIN B
- PETROLATUM
- MINERAL OIL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 53002-9271 | 53002-9271-1 |
| 24208-555 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BACITRACIN ZINC | 89Y4M234ES | ACTIM |
| POLYMYXIN B SULFATE | 19371312D4 | ACTIM |
| PETROLATUM | 4T6H12BN9U | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A064046-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | BACITRACIN ZINC; POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | RS | 1995-01-26 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A064046-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | RS | 1995-01-26 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A064046-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | RS | 1995-01-26 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A064046-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | RS | 1995-01-26 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A064046-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | RS | 1995-01-26 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A064046-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | RS | 1995-01-26 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A064046-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | RS | 1995-01-26 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A064046-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | RS | 1995-01-26 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A064046-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | RS | 1995-01-26 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A064046-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | RS | 1995-01-26 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A064046-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | RS | 1995-01-26 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A064046-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | RS | 1995-01-26 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A064046-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | RS | 1995-01-26 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A064046-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | RS | 1995-01-26 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A064046-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | RS | 1995-01-26 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A064046-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | RS | 1995-01-26 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A064046-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | RS | 1995-01-26 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A064046-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | RS | 1995-01-26 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A064046-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | RS | 1995-01-26 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A064046-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | RS | 1995-01-26 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A064046-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | RS | 1995-01-26 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A064046-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | RS | 1995-01-26 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A064046-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | RS | 1995-01-26 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A064046-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | RS | 1995-01-26 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A064046-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | RS | 1995-01-26 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A064046-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | RS | 1995-01-26 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A064046-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | RS | 1995-01-26 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A064046-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | RS | 1995-01-26 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A064046-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | RS | 1995-01-26 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A064046-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | RS | 1995-01-26 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A064046-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | RS | 1995-01-26 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A064046-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | RS | 1995-01-26 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A064046-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | RS | 1995-01-26 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A064046-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | RS | 1995-01-26 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A064046-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | RS | 1995-01-26 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A064046-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | RS | 1995-01-26 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A064046-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | RS | 1995-01-26 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A064046-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | RS | 1995-01-26 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A064046-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | RS | 1995-01-26 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A064046-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | RS | 1995-01-26 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A064046-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | AT | RS | 1995-01-26 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A064046-001 | AT | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A064046-001 | AT | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A064046-001 | AT | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A064046-001 | AT | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A064046-001 | AT | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A064046-001 | AT | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A064046-001 | AT | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A064046-001 | AT | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A064046-001 | AT | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A064046-001 | AT | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A064046-001 | AT | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A064046-001 | AT | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A064046-001 | AT | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A064046-001 | AT | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A064046-001 | AT | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A064046-001 | AT | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A064046-001 | AT | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A064046-001 | AT | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A064046-001 | AT | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A064046-001 | AT | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A064046-001 | AT | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A064046-001 | AT | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A064046-001 | AT | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A064046-001 | AT | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A064046-001 | AT | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A064046-001 | AT | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A064046-001 | AT | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A064046-001 | AT | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A064046-001 | AT | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A064046-001 | AT | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A064046-001 | AT | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A064046-001 | AT | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A064046-001 | AT | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A064046-001 | AT | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A064046-001 | AT | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A064046-001 | AT | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A064046-001 | AT | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A064046-001 | AT | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A064046-001 | AT | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A064046-001 | AT | 1 | cb3db0bc1861… |
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 and Polymyxin B Sulfate | BACITRACIN ZINC AND POLYMYXIN B SULFATE | Bausch & Lomb Incorporated | 1b317249-30eb-4415-8a1c-cfedb4ba3549 | 2024-10-18 | Warnings, Adverse reactions | 24208-555 |
| 244b7362-edd7-45fe-874a-41bcf15b4cda | 51c5b733-ee9d-4f34-bdc6-38c837e0dee8 | 2023-06-07 | Warnings, Adverse reactions | 244b7362-edd7-45fe-874a-41bcf15b4cda 51c5b733-ee9d-4f34-bdc6-38c837e0dee8 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.