Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution

Manufacturer: Akorn
Effective date: 2022-07-01
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 9
Source: full-release
Hydrated at: 2026-05-31 20:42:13

Label at a glance#

ProductPOLYMYXIN B SULFATE AND TRIMETHOPRIM

Active ingredientTrimethoprim sulfate, Polymyxin B sulfate

Label structure12 sections

Indications and uses

Polymyxin B Sulfate and Trimethoprim 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 influenza and Pseudomonas aeruginosa. * *Eff...

Dosage and administration

Adults: 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. Pediatric Use: Clinical studies have shown Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution to be safe and effective for use in pediatric patients over two months of age. The dosage regimen is the same as for adults.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Rx only

DESCRIPTION

DESCRIPTION SECTION

Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution is a sterile antimicrobial solution for topical ophthalmic use. Trimethoprim sulfate, 2,4-diamino-5-(3,4,5-trimethoxybenzyl)pyrimidine sulfate (2:1), occurs as a white, odorless, crystalline powder with a molecular weight of 678.72. The structural formula is as follows:

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 formula is as follows:

Each mL contains:

Actives: Trimethoprim Sulfate equivalent to Trimethoprim 1 mg (0.1%) and Polymyxin B Sulfate 10,000 units. Preservative: Benzalkonium Chloride 0.04 mg (0.004%). Inactives: Sodium Chloride, Sulfuric Acid and Sodium Hydroxide may be added to adjust pH (3.0 to 5.5), and Water for Injection.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

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 very much stronger for the bacterial enzyme than for the corresponding mammalian enzyme. For that reason, trimethoprim selectively interferes with bacterial biosynthesis of nucleic acids and proteins.

Polymyxin B, a cyclic lipopeptide antibiotic, is rapidly 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.

When used topically, trimethoprim and polymyxin B absorption through intact skin and mucous membranes is insignificant.

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 0.03 mcg/mL trimethoprim and 1 unit/mL polymyxin B.

MICROBIOLOGY SECTION

Microbiology: In vitro studies have demonstrated that the anti-infective components of Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution are active against the following bacterial pathogens that are capable of causing external infections of the eye:

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

Polymyxin B: Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes and Haemophilus influenzae.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae, Streptococcus viridans, Haemophilus influenza and Pseudomonas aeruginosa.*

*Efficacy for this organism in this organ system was studied in fewer than 10 infections.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution is contraindicated in patients with known hypersensitivity to any of its components.

WARNINGS

WARNINGS SECTION

NOT FOR INJECTION INTO THE EYE. If a sensitivity reaction to Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution occurs, discontinue use. Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution is not indicated for the prophylaxis or treatment of ophthalmic neonatorum.

PRECAUTIONS

PRECAUTIONS SECTION

GENERAL PRECAUTIONS SECTION

General: As with other antimicrobial preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated.

INFORMATION FOR PATIENTS SECTION

Information for Patients: 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.

Carcinogenesis, Mutagenesis, Impairment of Fertility

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

SPL UNCLASSIFIED SECTION

Carcinogenesis: Long-term studies in animals to evaluate carcinogenic potential have not been conducted with polymyxin B sulfate or trimethoprim.

SPL UNCLASSIFIED SECTION

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 1000 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.

SPL UNCLASSIFIED SECTION

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.

PREGNANCY SECTION

Pregnancy: 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 SECTION

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.

NURSING MOTHERS SECTION

Nursing mothers: 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 Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution is administered to a nursing woman.

PEDIATRIC USE SECTION

Pediatric Use: Safety and effectiveness in pediatric patients below the age of 2 months have not been established (see WARNINGS).

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

The most frequent adverse reaction to Polymyxin B Sulfate and Trimethoprim 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.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

SPL UNCLASSIFIED SECTION

Adults: 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.

SPL UNCLASSIFIED SECTION

Pediatric Use: Clinical studies have shown Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution to be safe and effective for use in pediatric patients over two months of age. The dosage regimen is the same as for adults.

HOW SUPPLIED

HOW SUPPLIED SECTION

Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution is supplied as a sterile solution in plastic dropper bottles in the following size: 10 mL in a 10 mL bottle NDC 17478-703-11

STORAGE AND HANDLING SECTION

STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.

WARNING – KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Akorn

Distributed by:
Akorn Operating Company LLC
Gurnee, IL 60031

ATP00N
Rev. 03/22

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC 17478-703-11

Polymyxin B Sulfate

and Trimethoprim

Ophthalmic Solution

10 mL

For the eye

Sterile

Rx only

Principal Display Panel Text for Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

NDC 17478-703-11

Polymyxin B

Sulfate and

Trimethoprim

Ophthalmic

Solution

For the eye

10 mL

Sterile

Rx only Akorn Logo

Principal Display Panel Text for Carton Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
244967	polymyxin B sulfate 10,000 UNT / trimethoprim sulfate 1 MG in ML Ophthalmic Solution	PSN	9
244967	polymyxin B 10000 UNT/ML / trimethoprim 1 MG/ML Ophthalmic Solution	SCD	9
244967	polymyxin B 10,000 UNT / trimethoprim (as trimethoprim sulfate) 0.1 % Ophthalmic Solution	SY	9
244967	polymyxin B 10,000 UNT / trimethoprim 0.1 % Ophthalmic Solution	SY	9
244967	Polymyxin B 10000 UNT/ML / TMP 1 MG/ML Ophthalmic Solution	SY	9

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
POLYMYXIN B Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813
TRIMETHOPRIM Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4ce811b5-329e-27f8-b5ff-66d52b435c00	Product name	3	20240108
8d30c4f0-0228-cea4-e3aa-f19064c47f27	Product name	3	20221128
6e20c430-5e8f-85da-1b03-f7dbc0c51fad	Product name	3	20190926
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0c	Product name	1	20160603
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
c1381fd7-868a-f499-ef90-8f6d3e3ee6b3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
17478-703-11	2024-01-30	C162847	48780-1	1030e365-5a3b-111a-e063-dadaa90a10e2	Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
17478-703-11	POLYMYXIN B SULFATE AND TRIMETHOPRIM	10 mL in 1 BOTTLE, DROPPER	SOLUTION	10		9
17478-703-11	POLYMYXIN B SULFATE AND TRIMETHOPRIM	1 in 1 CARTON	SOLUTION	1		9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17478-703	POLYMYXIN B SULFATE AND TRIMETHOPRIM SOLUTION [AKORN]	9	Legacy NDC, 2 package rows	20220706_507c7308-6526-40d7-b8aa-3ca7b5d8cc17.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17478-703-11	ML - Milliliter	17478-703	9e844551-b9ea-478b-a43c-72ee81e59018	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Polymyxin B sulfate	ACTIVE INGREDIENT	19371312D4	2
Trimethoprim sulfate	ACTIVE INGREDIENT	E377MF8EQ8	2
Polymyxin B	ACTIVE MOIETY	J2VZ07J96K	2
Trimethoprim	ACTIVE MOIETY	AN164J8Y0X	2
benzalkonium chloride	INACTIVE INGREDIENT	F5UM2KM3W7	2
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	2
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	2
sulfuric acid	INACTIVE INGREDIENT	O40UQP6WCF	2
water	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

POLYMYXIN B SULFATE AND TRIMETHOPRIM
Trimethoprim sulfate
Trimethoprim
Polymyxin B sulfate
Polymyxin B
benzalkonium chloride
sodium chloride
sulfuric acid
sodium hydroxide
water

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
17478-703	17478-703-11

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Trimethoprim sulfate	E377MF8EQ8	ACTIM
Polymyxin B sulfate	19371312D4	ACTIM
benzalkonium chloride	F5UM2KM3W7	IACT
sodium chloride	451W47IQ8X	IACT
sulfuric acid	O40UQP6WCF	IACT
sodium hydroxide	55X04QC32I	IACT
water	059QF0KO0R	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 360 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SYSTEM / IONTOPHORESIS	3.1 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRAVASCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR	0.35 %w/v		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / INTRAMUSCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION / INTRALESIONAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INTRAMUSCULAR		78 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	POWDER / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR		360 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
benzalkonium chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SUSPENSION / OPHTHALMIC		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAPERITONEAL	0.54 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	136.55 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sulfuric acid	SULFURIC ACID	O40UQP6WCF	SUSPENSION / AURICULAR (OTIC)	0.02 %w/v		Exact identifier — unii candidate 28 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, EMULSION / INTRAVENOUS	0.62 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / IONTOPHORESIS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRALESIONAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SYRUP / ORAL	71 mg/5ml		Exact identifier — unii candidate 174 equally ranked IID candidates
sulfuric acid	SULFURIC ACID	O40UQP6WCF	INJECTION, POWDER, FOR SOLUTION / PARENTERAL	ADJ PH		Exact identifier — unii candidate 28 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION/ DROPS / AURICULAR (OTIC)	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRAMUSCULAR		1486 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION/ DROPS / TOPICAL	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / OPHTHALMIC		13 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sulfuric acid	SULFURIC ACID	O40UQP6WCF	SUSPENSION / OPHTHALMIC	ADJ PH		Exact identifier — unii candidate 28 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		1800 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
benzalkonium chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	INJECTION / INTRALESIONAL		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
benzalkonium chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	LIQUID / NASAL	0.2 mg/1ml		Exact identifier — unii candidate 24 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / PARENTERAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / NASAL	330 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION/ DROPS / TOPICAL	0.23 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRAPLEURAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / DENTAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRAPERITONEAL	226 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / INTRADISCAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRAVENOUS		28773 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	TABLET, EXTENDED RELEASE / ORAL	335.1 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR		45 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	NA		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	POWDER, FOR SUSPENSION / ENDOTRACHEAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / TOPICAL	0.32 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / RECTAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION, EXTENDED RELEASE / INTRASYNOVIAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	IMPLANT / SUBCUTANEOUS	77 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION/ DROPS / AURICULAR (OTIC)		3 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sulfuric acid	SULFURIC ACID	O40UQP6WCF	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 28 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / ENDOTRACHEAL	7.6 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION / INTRAVITREAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	GRANULE, FOR SUSPENSION / ORAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRASYNOVIAL	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
sulfuric acid	SULFURIC ACID	O40UQP6WCF	INJECTION / ENDOTRACHEAL	ADJ PH		Exact identifier — unii candidate 28 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	LIQUID / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	LIQUID / NASAL	7.4 mg/1ml		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / INTRA-ARTERIAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRA-ARTERIAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	LIQUID / INTRAMUSCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	MOUTHWASH / BUCCAL	2 mg/1ml		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / IRRIGATION	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	ENEMA / RECTAL	0.44 %v/v		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRATHECAL	1.35 mg		Exact identifier — unii candidate 134 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT		1998-12-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A065006-001	AT

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065006-001	TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE	10,000 UNITS/ML;EQ 1MG BASE/ML	SOLUTION/DROPS / OPHTHALMIC	AT	1998-12-17	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A065006-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A065006-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065006-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065006-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065006-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065006-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065006-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065006-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065006-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065006-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065006-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065006-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065006-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065006-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065006-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065006-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065006-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065006-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065006-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065006-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065006-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A065006-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A065006-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A065006-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A065006-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A065006-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A065006-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A065006-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A065006-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A065006-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A065006-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A065006-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A065006-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A065006-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A065006-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A065006-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A065006-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A065006-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A065006-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A065006-001	AT	1	`f41ea6bd6efb…`

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
2f983ff2-7010-48e2-ac6b-b1343a0915f9			507c7308-6526-40d7-b8aa-3ca7b5d8cc17	2022-07-01	Warnings, Adverse reactions	Exact identifier spl id: 2f983ff2-7010-48e2-ac6b-b1343a0915f9 spl set id: 507c7308-6526-40d7-b8aa-3ca7b5d8cc17

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.