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
- Preferred Pharmaceuticals Inc.
- Effective date
- 2025-01-06
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 6
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 20:41:33
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 subtilisvar 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 B 1and B 2, 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 aeruginosaand Haemophilus influenzaespecies.
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
Bacitracin zinc and polymyxin B sulfate ophthalmic ointment, USP is available in tubes with an ophthalmic tip applicator in the following size:
NDC 68788-7599-3 - 3.5 g tube
Storage:
Store between 15°C to 25°C (59°F to 77°F). KEEP TIGHTLY CLOSED.
KEEP OUT OF REACH OF CHILDREN.
Distributed by:
Bausch & Lomb Americas Inc.
Bridgewater, NJ 08807 USA
Manufactured by:
Bausch & Lomb Incorporated
Tampa, FL 33637 USA
© 2023 Bausch & Lomb Incorporated or its affiliates
Revised: January 2023
Relabeled By: Preferred Pharmaceuticals Inc.
PRINCIPAL DISPLAY PANEL
NDC 68788-7599-3
Bacitracin Zinc
and Polymyxin B
Sulfate
Ophthalmic
Ointment, USP
(Sterile)
FOR OPHTHALMIC
USE ONLY
Rx onlyNet Wt. 3.5 g
(1/8 oz)
BAUSCH + LOMB
Relabeled By: Preferred Pharmaceuticals Inc.
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68788-7599 | BACITRACIN ZINC AND POLYMYXIN B SULFATE OINTMENT [PREFERRED PHARMACEUTICALS INC.] | 6 | Legacy NDC | 20250207_e6447ebb-9224-4a3e-ad74-0c923414aa07.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68788-7599-3 | GM - Gram | 68788-7599 | 177dcb01-b243-41eb-89de-695e982c0f0d | 1 | 2020-04-20 |
| 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 |
|---|---|
| 68788-7599 | 68788-7599-3 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A064046-001 | BACITRACIN ZINC AND POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT / OPHTHALMIC | RS | 1995-01-26 | c2088c7a36db… | |
| 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… |
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 |
|---|---|---|---|---|---|---|
| 38df5475-51c9-4413-8e34-e8bdb9d27d10 | e6447ebb-9224-4a3e-ad74-0c923414aa07 | 2025-05-28 | Warnings, Adverse reactions | e6447ebb-9224-4a3e-ad74-0c923414aa07 | ||
| 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 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.