SULFACETAMIDE SODIUM ophthalmic solution, USP 10%

Manufacturer: Pacific Pharma, Inc.
Effective date: 2018-10-19
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-02 00:48:47

Label at a glance#

Productsulfacetamide

Active ingredientsulfacetamide sodium

Label structure10 sections

Indications and uses

Sulfacetamide sodium solution is indicated for the treatment of conjunctivitis and other superficial ocular infections due to susceptible microorganisms, and as an adjunctive in systemic sulfonamide therapy of trachoma: Escherichia coli , Staphylococcus aureus , Streptococcus pneumoniae , Streptococcus (viridans group), Haemophilus influenzae , Klebsiella species, and Enterobacter species. Topically applied ...

Dosage and administration

For conjunctivitis and other superficial ocular infections: Instill one or two drops into the conjunctival sac(s) of the affected eye(s) every two to three hours initially. Dosages may be tapered by increasing the time interval between doses as the condition responds. The usual duration of treatment is seven to ten days. For trachoma: Instill two drops into the conjunctival sac(s) of the affected eye(s) every two ...

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

Sulfacetamide sodium ophthalmic solution, USP 10% is a sterile, topical anti-bacterial agent for ophthalmic use. The active ingredient is represented by the following structural formula:

the following structural formula for Sulfacetamide sodium ophthalmic solution, USP 10% is a sterile, topical anti-bacterial agent for ophthalmic use.

Chemical Name: N-Sulfanilylacetamide monosodium salt monohydrate.

Contains: Active: sulfacetamide sodium 10% (100 mg/mL)

Preservative: benzalkonium chloride 0.005%

lnactives: edetate disodium; polysorbate 80; polyvinyl alcohol 1.4%; purified water; sodium phosphate dibasic; sodium phosphate monobasic; sodium thiosulfate; hydrochloric acid and/or sodium hydroxide to adjust pH (6.8 to 7.5).

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

Microbiology: The sulfonamides are bacteriostatic agents and the spectrum of activity is similar for all. Sulfonamides inhibit bacterial synthesis of dihydrofolic acid by preventing the condensation of the pteridine with aminobenzoic acid through competitive inhibition of the enzyme dihydropteroate synthetase. Resistant strains have altered dihydropteroate synthetase with reduced affinity for sulfonamides or produce increased quantities of aminobenzoic acid.

Topically applied sulfonamides are considered active against susceptible strains of the following common bacterial eye pathogens: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species.

Topically applied sulfonamides do not provide adequate coverage against Neisseria species, Serratia marcescens and Pseudomonas aeruginosa. A significant percentage of staphylococcal isolates are completely resistant to sulfa drugs.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Sulfacetamide sodium solution is indicated for the treatment of conjunctivitis and other superficial ocular infections due to susceptible microorganisms, and as an adjunctive in systemic sulfonamide therapy of trachoma: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Sulfacetamide sodium solution is contraindicated in individuals who have a hypersensitivity to sulfonamides or to any ingredient of the preparation.

WARNINGS

WARNINGS SECTION

FOR TOPICAL EYE USE ONLY - NOT FOR INJECTION.

FATALITIES HAVE OCCURRED, ALTHOUGH RARELY, DUE TO SEVERE REACTIONS TO SULFONAMIDES INCLUDING STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS, FULMINANT HEPATIC NECROSIS, AGRANULOCYTOSIS, APLASTIC ANEMIA AND OTHER BLOOD DYSCRASIAS. Sensitizations may recur when a sulfonamide is readministered, irrespective of the route of administration. Sensitivity reactions have been reported in individuals with no prior history of sulfonamide hypersensitivity. At the first sign of hypersensitivity, skin rash or other serious reaction, discontinue use of this preparation.

PRECAUTIONS

PRECAUTIONS SECTION

General

GENERAL PRECAUTIONS SECTION

Prolonged use of topical anti-bacterial agents may give rise to overgrowth of nonsusceptible organisms including fungi. Bacterial resistance to sulfonamides may also develop.

The effectiveness of sulfonamides may be reduced by the para-aminobenzoic acid present in purulent exudates.

Sensitization may recur when a sulfonamide is readministered irrespective of the route of administration, and cross-sensitivity between different sulfonamides may occur.

At the first sign of hypersensitivity, increase in purulent discharge, or aggravation of inflammation or pain, the patient should discontinue use of the medication and consult a physician (see WARNINGS).

Information for Patients

INFORMATION FOR PATIENTS SECTION

To avoid contamination, do not touch tip of container to the eye, eyelid or any surface.

Drug Interactions

DRUG INTERACTIONS SECTION

Sulfacetamide preparations are incompatible with silver preparations.

Carcinogenesis, Mutagenesis, Impairment of Fertility

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

No studies have been conducted in animals or in humans to evaluate the possibility of these effects with ocularly administered sulfacetamide. Rats appear to be especially susceptible to the goitrogenic effects of sulfonamides, and long-term oral administration of sulfonamides has resulted in thyroid malignancies in these animals.

Pregnancy

PREGNANCY SECTION

Animal reproduction studies have not been conducted with sulfonamide ophthalmic preparations. Kernicterus may occur in the newborn as a result of treatment of a pregnant woman at term with orally administered sulfonamides. There are no adequate and well controlled studies of sulfonamide ophthalmic preparations in pregnant women and it is not known whether topically applied sulfonamides can cause fetal harm when administered to a pregnant woman. This product should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

NURSING MOTHERS SECTION

Systemically administered sulfonamides are capable of producing kernicterus in infants of lactating women. Because of the potential for the development of kernicterus in neonates, a decision should be made whether to discontinue nursing or discontinue the drug taking into account the importance of the drug to the mother.

Pediatric Use

PEDIATRIC USE SECTION

Safety and effectiveness in infants below the age of two months have not been established.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

Bacterial and fungal corneal ulcers have developed during treatment with sulfonamide ophthalmic preparations.

The most frequently reported reactions are local irritation, stinging and burning. Less commonly reported reactions include non-specific conjunctivitis, conjunctival hyperemia, secondary infections and allergic reactions.

Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias (see WARNINGS).

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

For conjunctivitis and other superficial ocular infections: Instill one or two drops into the conjunctival sac(s) of the affected eye(s) every two to three hours initially. Dosages may be tapered by increasing the time interval between doses as the condition responds. The usual duration of treatment is seven to ten days.

For trachoma: Instill two drops into the conjunctival sac(s) of the affected eye(s) every two hours. Topical administration must be accompanied by systemic administration.

HOW SUPPLIED

HOW SUPPLIED SECTION

Sulfacetamide sodium ophthalmic solution, USP 10% is supplied sterile in opaque white LDPE plastic bottles and white dropper tips with white high impact polystyrene (HIPS) caps as follows:

5 mL in 10 mL bottle - NDC 60758-018-05

Storage:

STORAGE AND HANDLING SECTION

Store at 8°-25°C (46°-77°F). Protect from light. Sulfonamide solutions, on long standing, will darken in color and should be discarded.

Revised: 9/2018

Distributed for: Allergan USA, Inc.
Madison, NJ 07940
© 2018 Allergan. All rights reserved.
All trademarks are the property of their respective owners.

v1.0USPI018

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 60758-018-05
Rx Only
SULFACETAMIDE
SODIUM

Ophthalmic
solution,
USP
10%
Sterile

PRINCIPAL DISPLAY PANEL NDC 60758-018-05 Rx Only SULFACETAMIDE SODIUM Ophthalmic solution, USP 10% Sterile

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60758-018-05	ML - Milliliter	60758-018	70f52e2a-113d-4539-a1ae-885aab747ee8	1	2015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
sulfacetamide sodium	ACTIVE INGREDIENT	4NRT660KJQ	1
sulfacetamide	ACTIVE MOIETY	4965G3J0F5	1
benzalkonium chloride	INACTIVE INGREDIENT	F5UM2KM3W7	1
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	1
hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	1
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	1
polyvinyl alcohol	INACTIVE INGREDIENT	532B59J990	1
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	1
sodium phosphate, dibasic, anhydrous	INACTIVE INGREDIENT	22ADO53M6F	1
sodium phosphate, monobasic	INACTIVE INGREDIENT	3980JIH2SW	1
sodium thiosulfate	INACTIVE INGREDIENT	HX1032V43M	1
water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

sulfacetamide
sulfacetamide sodium
benzalkonium chloride
edetate disodium
polysorbate 80
POLYVINYL ALCOHOL, UNSPECIFIED
water
sodium phosphate, dibasic, anhydrous
sodium phosphate, monobasic
sodium thiosulfate
hydrochloric acid
sodium hydroxide

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
60758-018	60758-018-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
sulfacetamide sodium	4NRT660KJQ	ACTIB
benzalkonium chloride	F5UM2KM3W7	IACT
edetate disodium	7FLD91C86K	IACT
polysorbate 80	6OZP39ZG8H	IACT
POLYVINYL ALCOHOL, UNSPECIFIED	532B59J990	IACT
water	059QF0KO0R	IACT
sodium phosphate, dibasic, anhydrous	22ADO53M6F	IACT
sodium phosphate, monobasic	3980JIH2SW	IACT
sodium thiosulfate	HX1032V43M	IACT
hydrochloric acid	QTT17582CB	IACT
sodium hydroxide	55X04QC32I	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 10 · 585 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRA-ARTERIAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	GRANULE, FOR SUSPENSION / ORAL		240 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	SYRUP / ORAL	2.03 mg/1ml		Exact identifier — unii candidate 148 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	DROPS / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION / INTRAMUSCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
polyvinyl alcohol	POLYVINYL ALCOHOL	532B59J990	TABLET / ORAL		165 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION / INTRAVENOUS	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	TABLET / ORAL		10 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION / INTRAVASCULAR	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	TABLET, EXTENDED RELEASE / ORAL		10 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRA-ARTERIAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRAVENOUS		456 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / SUBCUTANEOUS		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION / PARENTERAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION / INTRAPLEURAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	SUSPENSION/ DROPS / TOPICAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	SPRAY / NASAL	0.01 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SOLUTION / INTRAVENOUS	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
sodium phosphate, monobasic	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS	0.22 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / RESPIRATORY (INHALATION)	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / RESPIRATORY (INHALATION)		1 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SOLUTION / INTRAMUSCULAR	5 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 148 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
polyvinyl alcohol	POLYVINYL ALCOHOL	532B59J990	TABLET, EXTENDED RELEASE / ORAL		96 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SUSPENSION/ DROPS / OPHTHALMIC		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	CAPSULE / ORAL		7 mg	Exact identifier — unii candidate 148 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	MOUTHWASH / BUCCAL	2 mg/1ml		Exact identifier — unii candidate 174 equally ranked IID candidates
benzalkonium chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	GEL / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
sodium phosphate, dibasic, anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION / INTRAMUSCULAR		1751 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION, POWDER, FOR SOLUTION / INTRADERMAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	TABLET, FILM COATED / ORAL		8 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	OINTMENT / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / SUBCUTANEOUS	0.3 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	POWDER, FOR SUSPENSION / ORAL		396 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION / INTRA-AMNIOTIC	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION / PERINEURAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
benzalkonium chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	CLOTH / TOPICAL	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION, SUSPENSION / INTRAMUSCULAR	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
benzalkonium chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	OINTMENT / TOPICAL	0.03 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRATHECAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	LIQUID / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	CAPSULE, LIQUID FILLED / ORAL	1.5 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	GEL / OPHTHALMIC		6 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / SOFT TISSUE	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION / INTRASYNOVIAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		34 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	SOLUTION / AURICULAR (OTIC)	0.37 %w/v		Exact identifier — unii candidate 148 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / INTRA-ARTERIAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	LIQUID / ORAL	0.5 mg/1ml		Exact identifier — unii candidate 77 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / PARENTERAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium phosphate, dibasic, anhydrous	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INSERT / INTRAOCULAR	0.02 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
benzalkonium chloride	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SUSPENSION/ DROPS / TOPICAL	NA		Exact identifier — unii candidate 24 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	GEL / VAGINAL		20 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRAVASCULAR	0.48 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	GEL, METERED / TRANSDERMAL		350 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
polysorbate 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	53 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	160 mg		Exact identifier — unii candidate 148 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	SOLUTION / NASAL	91.7 mg/100ml		Exact identifier — unii candidate 148 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 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A080028-001	BLEPH-10	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC		RLD, Approved before 1982
A080028-002	BLEPH-30	SULFACETAMIDE SODIUM	30%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982

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 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-10-15 13:18:30	2026-09	A080028-001	BLEPH-10	10%	SOLUTION/DROPS / OPHTHALMIC		RLD, Approved before 1982	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A080028-002	BLEPH-30	30%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A080028-001	BLEPH-10	10%	SOLUTION/DROPS / OPHTHALMIC		RLD, Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A080028-002	BLEPH-30	30%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A080028-001	BLEPH-10	10%	SOLUTION/DROPS / OPHTHALMIC		RLD, Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A080028-002	BLEPH-30	30%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A080028-001	BLEPH-10	10%	SOLUTION/DROPS / OPHTHALMIC		RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A080028-002	BLEPH-30	30%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080028-001	BLEPH-10	10%	SOLUTION/DROPS / OPHTHALMIC		RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080028-002	BLEPH-30	30%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080028-001	BLEPH-10	10%	SOLUTION/DROPS / OPHTHALMIC		RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A080028-002	BLEPH-30	30%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080028-001	BLEPH-10	10%	SOLUTION/DROPS / OPHTHALMIC		RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080028-002	BLEPH-30	30%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080028-001	BLEPH-10	10%	SOLUTION/DROPS / OPHTHALMIC		RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080028-002	BLEPH-30	30%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080028-001	BLEPH-10	10%	SOLUTION/DROPS / OPHTHALMIC		RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080028-002	BLEPH-30	30%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080028-001	BLEPH-10	10%	SOLUTION/DROPS / OPHTHALMIC		RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080028-002	BLEPH-30	30%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080028-001	BLEPH-10	10%	SOLUTION/DROPS / OPHTHALMIC		RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080028-002	BLEPH-30	30%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080028-001	BLEPH-10	10%	SOLUTION/DROPS / OPHTHALMIC		RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080028-002	BLEPH-30	30%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080028-001	BLEPH-10	10%	SOLUTION/DROPS / OPHTHALMIC		RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A080028-002	BLEPH-30	30%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080028-001	BLEPH-10	10%	SOLUTION/DROPS / OPHTHALMIC		RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080028-002	BLEPH-30	30%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080028-001	BLEPH-10	10%	SOLUTION/DROPS / OPHTHALMIC		RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080028-002	BLEPH-30	30%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080028-001	BLEPH-10	10%	SOLUTION/DROPS / OPHTHALMIC		RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080028-002	BLEPH-30	30%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080028-001	BLEPH-10	10%	SOLUTION/DROPS / OPHTHALMIC		RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A080028-002	BLEPH-30	30%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080028-001	BLEPH-10	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080028-002	BLEPH-30	30%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080028-001	BLEPH-10	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A080028-002	BLEPH-30	30%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080028-001	BLEPH-10	10%	SOLUTION/DROPS / OPHTHALMIC	AT	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A080028-002	BLEPH-30	30%	SOLUTION/DROPS / OPHTHALMIC		Approved before 1982	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080028-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A080028-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A080028-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A080028-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A080028-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A080028-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A080028-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A080028-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080028-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080028-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080028-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080028-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080028-001	AT	1	`ea99ee380514…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080028-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080028-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080028-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080028-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080028-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080028-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080028-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080028-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A080028-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080028-001	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.

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
ef62fabb-f42a-42d5-bab4-190d22af9933			5e0415cd-5803-44b2-be24-af823c48c6d0	2018-10-01	Warnings, Adverse reactions	Exact identifier spl set id: 5e0415cd-5803-44b2-be24-af823c48c6d0

Reported adverse events (FAERS/openFDA)#

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