POLYTRIM ® Ophthalmic Solution is indicated in the treatment of surface ocular bacterial infections, including acute bacterial conjunctivitis, and blepharoconjunctivitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus , Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus viridans, Haemophilus influenzae and Pseudomonas aeruginosa. Efficacy for this organism in ...
In mild to moderate infections, instill one drop in the affected eye(s) every three hours (maximum of 6 doses per day) for a period of 7 to 10 days.
Sterile
POLYTRIM® (polymyxin B sulfate and trimethoprim ophthalmic solution, USP) is a sterile antimicrobial solution for topical ophthalmic use. It has pH of 4.0 to 6.2 and osmolality of 270 to 310 mOsm/kg.
Trimethoprim sulfate, 2,4-Diamino-5-(3,4,5-trimethoxybenzyl) pyrimidine sulfate, is a white, odorless, crystalline powder with a molecular weight of 678.72 and the following structural formula:
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 per mg, calculated on an anhydrous basis. The structural formulae are:
Contains: Actives: polymyxin B sulfate 10,000 units/mL; trimethoprim sulfate equivalent to 1 mg/mL. Preservative: benzalkonium chloride 0.04 mg/mL. Inactives: purified water; sodium chloride; and sulfuric acid. May also contain sodium hydroxide to adjust the pH.
Trimethoprim is a synthetic antibacterial drug active against a wide variety of aerobic gram-positive and gram-negative ophthalmic pathogens. Trimethoprim blocks the production of tetrahydrofolic acid from dihydrofolic acid by binding to and reversibly inhibiting the enzyme dihydrofolate reductase. This binding is stronger for the bacterial enzyme than for the corresponding mammalian enzyme and therefore selectively interferes with bacterial biosynthesis of nucleic acids and proteins.
Polymyxin B, a cyclic lipopeptide antibiotic, is bactericidal for a variety of gram-negative organisms, especially Pseudomonas aeruginosa. It increases the permeability of the bacterial cell membrane by interacting with the phospholipid components of the membrane.
Blood samples were obtained from 11 human volunteers at 20 minutes, 1 hour and 3 hours following instillation in the eye of 2 drops of ophthalmic solution containing 1 mg trimethoprim and 10,000 units polymyxin B per mL. Peak serum concentrations were approximately 0.03μg/mL trimethoprim and 1 unit/mL polymyxin B.
Microbiology: In vitro studies have demonstrated that the anti-infective components of POLYTRIM® are active against the following bacterial pathogens that are capable of causing external infections of the eye:
Trimethoprim: Staphylococcus aureus and Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus faecalis, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus aegyptius, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis (indole-negative), Proteus vulgaris (indole-positive), Enterobacter aerogenes and Serratia marcescens.
Polymyxin B: Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes and Haemophilus influenzae.
POLYTRIM® Ophthalmic Solution is indicated in the treatment of surface ocular bacterial infections, including acute bacterial conjunctivitis, and blepharoconjunctivitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus viridans, Haemophilus influenzae and Pseudomonas aeruginosa. 1
1 Efficacy for this organism in this organ system was studied in fewer than 10 infections.
POLYTRIM® Ophthalmic Solution is contraindicated in patients with known hypersensitivity to any of its components.
NOT FOR INJECTION INTO THE EYE. If a sensitivity reaction to POLYTRIM® occurs, discontinue use. POLYTRIM® Ophthalmic Solution is not indicated for the prophylaxis or treatment of ophthalmia neonatorum.
As with other antimicrobial preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated.
Avoid contaminating the applicator tip with material from the eye, fingers, or other source. This precaution is necessary if the sterility of the drops is to be maintained.
If redness, irritation, swelling or pain persists or increases, discontinue use immediately and contact your physician. Patients should be advised not to wear contact lenses if they have signs and symptoms of ocular bacterial infections.
Carcinogenesis: Long-term studies in animals to evaluate carcinogenic potential have not been conducted with polymyxin B sulfate or trimethoprim.
Mutagenesis: Trimethoprim was demonstrated to be non-mutagenic in the Ames assay. In studies at two laboratories no chromosomal damage was detected in cultured Chinese hamster ovary cells at concentrations approximately 500 times human plasma levels after oral administration; at concentrations approximately 1,000 times human plasma levels after oral administration in these same cells, a low level of chromosomal damage was induced at one of the laboratories. Studies to evaluate mutagenic potential have not been conducted with polymyxin B sulfate.
Impairment of Fertility: Polymyxin B sulfate has been reported to impair the motility of equine sperm, but its effects on male or female fertility are unknown.
No adverse effects on fertility or general reproductive performance were observed in rats given trimethoprim in oral dosages as high as 70 mg/kg/day for males and 14 mg/kg/day for females.
Teratogenic Effects: Pregnancy Category C. Animal reproduction studies have not been conducted with polymyxin B sulfate. It is not known whether polymyxin B sulfate can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
Trimethoprim has been shown to be teratogenic in the rat when given in oral doses 40 times the human dose. In some rabbit studies, the overall increase in fetal loss (dead and resorbed and malformed conceptuses) was associated with oral doses 6 times the human therapeutic dose.
While there are no large well-controlled studies on the use of trimethoprim in pregnant women, Brumfitt and Pursell, in a retrospective study, reported the outcome of 186 pregnancies during which the mother received either placebo or oral trimethoprim in combination with sulfamethoxazole. The incidence of congenital abnormalities was 4.5% (3 of 66) in those who received placebo and 3.3% (4 of 120) in those receiving trimethoprim and sulfamethoxazole. There were no abnormalities in the 10 children whose mothers received the drug during the first trimester. In a separate survey, Brumfitt and Pursell also found no congenital abnormalities in 35 children whose mothers had received oral trimethoprim and sulfamethoxazole at the time of conception or shortly thereafter.
Because trimethoprim may interfere with folic acid metabolism, trimethoprim should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nonteratogenic Effects: The oral administration of trimethoprim to rats at a dose of 70 mg/kg/day commencing with the last third of gestation and continuing through parturition and lactation caused no deleterious effects on gestation or pup growth and survival.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when POLYTRIM® Ophthalmic Solution is administered to a nursing woman.
Safety and effectiveness in children below the age of 2 months have not been established (see WARNINGS).
No overall differences in safety or effectiveness have been observed between elderly and other adult patients.
The most frequent adverse reaction to POLYTRIM® Ophthalmic Solution is local irritation consisting of increased redness, burning, stinging, and/or itching. This may occur on instillation, within 48 hours, or at any time with extended use. There are also multiple reports of hypersensitivity reactions consisting of lid edema, itching, increased redness, tearing, and/or circumocular rash. Photosensitivity has been reported in patients taking oral trimethoprim.
In mild to moderate infections, instill one drop in the affected eye(s) every three hours (maximum of 6 doses per day) for a period of 7 to 10 days.
Product: 50090-1540
NDC: 50090-1540-0 10 mL in a BOTTLE, DROPPER
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-1540-0 | 2020-02-14 | C162847 | 48780-1 | 9d75b9d0-1495-f424-e053-dadaa90a57ce | POLYTRIM ® (polymyxin B sulfate and trimethoprim ophthalmic solution, USP) |
| 50090-1540-0 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-1495-f424-e053-dadaa90a57ce | POLYTRIM ® (polymyxin B sulfate and trimethoprim ophthalmic solution, USP) |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0023-7824-10 | ML - Milliliter | 0023-7824 | 1b2d2413-03d0-479a-82e5-09c7fa085f6d | 1 | 2012-07-24 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 50090-1540 | 50090-1540-0 |
| 0023-7824 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POLYMYXIN B SULFATE | 19371312D4 | ACTIM |
| TRIMETHOPRIM SULFATE | E377MF8EQ8 | ACTIM |
| water | 059QF0KO0R | IACT |
| sodium chloride | 451W47IQ8X | IACT |
| sulfuric acid | O40UQP6WCF | IACT |
| benzalkonium chloride | F5UM2KM3W7 | IACT |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N050567-001 | POLYTRIM | POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE | 10,000 UNITS/ML;EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1988-10-20 |
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 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1988-10-20 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1988-10-20 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1988-10-20 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1988-10-20 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1988-10-20 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1988-10-20 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1988-10-20 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD | 1988-10-20 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | RLD | 1988-10-20 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | RLD | 1988-10-20 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | RLD | 1988-10-20 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | RLD | 1988-10-20 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | RLD | 1988-10-20 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | RLD | 1988-10-20 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | RLD | 1988-10-20 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | RLD | 1988-10-20 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 1988-10-20 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 1988-10-20 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 1988-10-20 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 1988-10-20 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 1988-10-20 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 1988-10-20 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 1988-10-20 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 1988-10-20 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 1988-10-20 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 1988-10-20 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 1988-10-20 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 1988-10-20 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 1988-10-20 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | RLD | 1988-10-20 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | RLD | 1988-10-20 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | RLD | 1988-10-20 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | RLD | 1988-10-20 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | RLD | 1988-10-20 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | RLD | 1988-10-20 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | RLD | 1988-10-20 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | RLD | 1988-10-20 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 1988-10-20 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 1988-10-20 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N050567-001 | POLYTRIM | 10,000 UNITS/ML;EQ 1MG BASE/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RLD, RS | 1988-10-20 | f41ea6bd6efb… |
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N050567-001 | AT | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N050567-001 | AT | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N050567-001 | AT | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N050567-001 | AT | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N050567-001 | AT | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N050567-001 | AT | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N050567-001 | AT | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N050567-001 | AT | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N050567-001 | AT | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N050567-001 | AT | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N050567-001 | AT | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N050567-001 | AT | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N050567-001 | AT | 1 | ea99ee380514… |
| 2023-01-26 05:58 UTC | 2023-01 | N050567-001 | AT | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N050567-001 | AT | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N050567-001 | AT | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N050567-001 | AT | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N050567-001 | AT | 1 | cb3db0bc1861… |
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 |
|---|---|---|---|---|---|---|
| 6d1c5283-7ff3-4e72-b713-bf602fd85563 | f1f9b446-baff-4cd6-9f29-c45bb4a8951f | 2017-11-22 | Warnings, Adverse reactions | 6d1c5283-7ff3-4e72-b713-bf602fd85563 f1f9b446-baff-4cd6-9f29-c45bb4a8951f |
Adverse event summaries are temporarily unavailable. Other product information remains available.