SULFACETAMIDE SODIUM OPHTHALMIC SOLUTION USP, 10%

Manufacturer: H.J. Harkins Company, Inc. | Falcon Pharmaceuticals, Ltd. | Alcon Laboratories, Inc.
Effective date: 2011-11-17
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-05-31 20:13:18

Label at a glance#

ProductSulfacetamide Sodium

Active ingredientSULFACETAMIDE SODIUM

Label structure10 sections

Indications and uses

Sulfacetamide Sodium Ophthalmic Solution USP, 10% 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. Topicall...

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 10% is a sterile topical antibacterial agents for ophthalmic use. The active ingredient is represented by the following structural formula:

C₈H₉N₂Na0₃S • H₂O

MW = 254.24

Chemical Name:

N-Sulfanilylacetamide monosodium salt monohydrate.

Contains:

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

Preservative: methylparaben and propylparaben

Inactives: sodium thiosulfate, methylcellulose, and monobasic sodium phosphate

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

Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species.

Contraindications

CONTRAINDICATIONS SECTION

Sulfacetamide Sodium Ophthalmic 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 antibacterial 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

Pregnancy Category C. 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

Systematically 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 children 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 plastic bottles in the following sizes:

15 mL: NDC 61314-701-01

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

Rx Only

SPL UNCLASSIFIED SECTION

Dist. by:

FALCON Pharmaceuticals, Ltd

Fort Worth, Texas 76134

Mfd. by:

ALCON LABORATORIES, INC.

Fort Worth, Texas 76134

Printed in USA

340192-1102

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 61314-701-01 Rx Only

FALCON PHARMACEUTICALS^®

Sulfacetamide

Sodium

Ophthalmic

Solution USP

10%

15 mL STERILE

AFFILIATE OF

ALCON LABORATORIES, INC.

QUALITY RX

Repacked by:
H.J. Harkins Company, Inc.
Nipomo, CA 93444

thelabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1006120	sulfacetamide sodium 10 % Ophthalmic Solution	PSN	4
1006120	sulfacetamide sodium 100 MG/ML Ophthalmic Solution	SCD	4
1006120	sulfacetamide sodium 10 % Eye Drops	SY	4
1006120	sulfacetamide sodium 10 % Ophthalmic Solution	SY	4

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
SULFACETAMIDE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4073022c-5d5d-48f5-82ed-091ad146a4b2	Product name	1	20171211
9ffbd0ae-0bce-c086-b707-f0da5f8cd7c5	Product name	1	20150828
0304b7d2-7a07-d53b-750f-36012ae6612e	Product name	1	20140508
64c0cc7e-6478-3ca1-8cd7-9a1251d5a3f6	Product name	1	20140508
9ae74339-0a3d-82e9-5dd1-88bd2607bd6b	Product name	1	20140508
e44e38a9-2d9e-b0e2-cce9-490554639f3d	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52959-117-01	2019-11-13	C162847	48780-1	97449f38-b54c-f6ea-e053-dbdaa90aa703	SULFACETAMIDE SODIUM OPHTHALMIC SOLUTION USP, 10%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52959-117-01	Sulfacetamide Sodium	15 mL in 1 BOTTLE, PLASTIC	SOLUTION	15		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-117	SULFACETAMIDE SODIUM SOLUTION [H.J. HARKINS COMPANY, INC.]	4	Legacy NDC, 1 package rows	20111118_92f53dc3-cedc-4963-911a-77c3431d4765.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52959-117-01	ML - Milliliter	52959-117	87f9791d-1c59-408f-9151-c62d3f093ec6	1	2012-07-24
61314-701-01	ML - Milliliter	61314-701	65ec26b1-74aa-4d77-82d1-dc7cefa90ab6	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
SULFACETAMIDE SODIUM	ACTIVE INGREDIENT	4NRT660KJQ	4
SULFACETAMIDE	ACTIVE MOIETY	4965G3J0F5	4
METHYLCELLULOSE (4000 CPS)	INACTIVE INGREDIENT	MRJ667KA5E	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	4
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	4
SODIUM PHOSPHATE, MONOBASIC	INACTIVE INGREDIENT	3980JIH2SW	4
SODIUM THIOSULFATE	INACTIVE INGREDIENT	HX1032V43M	4

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

Sulfacetamide Sodium
SULFACETAMIDE
METHYLPARABEN
PROPYLPARABEN
SODIUM THIOSULFATE
METHYLCELLULOSE (4000 CPS)
SODIUM PHOSPHATE, MONOBASIC

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
52959-117	52959-117-01
61314-701

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SULFACETAMIDE SODIUM	4NRT660KJQ	ACTIB
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
SODIUM THIOSULFATE	HX1032V43M	IACT
METHYLCELLULOSE (4000 CPS)	MRJ667KA5E	IACT
SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	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 3 · 170 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CAPSULE / ORAL		7 mg	Exact identifier — unii candidate 79 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
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRALESIONAL	0.15 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, CHEWABLE / ORAL	1.28 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INFILTRATION	0.35 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM THIOSULFATE	SODIUM THIOSULFATE	HX1032V43M	SUSPENSION/ DROPS / OPHTHALMIC	3.15 %w/w		Exact identifier — unii candidate 10 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GEL / TOPICAL		24 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION/ DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RECTAL	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRADERMAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	SYSTEM / IONTOPHORESIS	14.2 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
SODIUM THIOSULFATE	SODIUM THIOSULFATE	HX1032V43M	INJECTION / INTRAVENOUS		18 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
SODIUM THIOSULFATE	SODIUM THIOSULFATE	HX1032V43M	SOLUTION/ DROPS / ORAL	0.5 mg/1ml		Exact identifier — unii candidate 10 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / INTRAMUSCULAR	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / PERINEURAL		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GRANULE, FOR SUSPENSION / ORAL		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CAPSULE, EXTENDED RELEASE / ORAL	0.22 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / AURICULAR (OTIC)	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / IONTOPHORESIS	0.1 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / NASAL	26 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	INJECTION / INTRAVENOUS		161 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	15 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / RECTAL		1808 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	JELLY / TOPICAL		180 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION, CONCENTRATE / ORAL	0.2 mg/1ml		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / EPIDURAL		30 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	FILM / BUCCAL	0.22 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	OINTMENT / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / ORAL		388 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET / ORAL	0.2 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / INTRAVENOUS	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	JELLY / NASAL	250 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	DROPS / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	AEROSOL, FOAM / TOPICAL	0.16 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CONCENTRATE / ORAL	2.5 mg/5ml		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / PARENTERAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	SOLUTION / ORAL	25 mg/5ml		Exact identifier — unii candidate 9 equally ranked IID candidates
METHYLCELLULOSE (4000 CPS)	METHYLCELLULOSE (4000 MPA.S)	MRJ667KA5E	TABLET, DELAYED RELEASE / ORAL		101 mg	Exact identifier — unii candidate 4 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / ORAL		64 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / RECTAL	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CAPSULE / ORAL		1 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	ELIXIR / ORAL	200 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / NASAL	250 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	LIQUID / ORAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRA-ARTICULAR	0.03 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / INTRAVENOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SYSTEM / TOPICAL		21 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	LOTION / TOPICAL		351 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	POWDER, FOR SOLUTION / ORAL		13 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	LIQUID / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SHAMPOO, SUSPENSION / TOPICAL	0.15 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	ENEMA / RECTAL	0.18 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
SODIUM THIOSULFATE	SODIUM THIOSULFATE	HX1032V43M	SOLUTION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 10 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SHAMPOO / TOPICAL	0.03 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLCELLULOSE (4000 CPS)	METHYLCELLULOSE (4000 MPA.S)	MRJ667KA5E	CREAM / TOPICAL	1.3 %w/w		Exact identifier — unii candidate 4 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
A089560-001	SULFACETAMIDE SODIUM	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT		1988-10-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A089560-001	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	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089560-001	SULFACETAMIDE SODIUM	10%	SOLUTION/DROPS / OPHTHALMIC	AT	1988-10-18	`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	A089560-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A089560-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089560-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089560-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089560-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089560-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089560-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089560-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089560-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089560-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089560-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089560-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089560-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089560-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089560-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089560-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089560-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089560-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089560-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089560-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089560-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089560-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089560-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089560-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089560-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089560-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089560-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089560-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089560-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089560-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089560-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089560-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089560-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089560-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089560-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089560-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089560-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089560-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089560-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089560-001	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
629fd51c-0ad7-4ea2-9661-1d654bcbbd17			92f53dc3-cedc-4963-911a-77c3431d4765	2011-11-17	Warnings, Adverse reactions	Exact identifier spl id: 629fd51c-0ad7-4ea2-9661-1d654bcbbd17 spl set id: 92f53dc3-cedc-4963-911a-77c3431d4765

Reported adverse events (FAERS/openFDA)#

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