GENTAMICIN SULFATE Ophthalmic Solution, USP 0.3%

Manufacturer: Rebel Distributors Corp
Effective date: 2010-09-27
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 20:10:35

Label at a glance#

ProductGENTAMICIN SULFATE

Active ingredientgentamicin sulfate

Label structure11 sections

Indications and uses

GENTAMICIN SULFATE OPHTHALMIC SOLUTION, USP is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus...

Dosage and administration

Instill one or two drops into the affected eye(s) every four hours. In severe infections, dosage may be increased to as much as two drops every hour.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Sterile

DESCRIPTION

DESCRIPTION SECTION

GENTAMICIN SULFATE OPHTHALMIC SOLUTION, USP is a sterile, topical anti-infective agent for ophthalmic use. The active ingredient, gentamicin sulfate, is a water-soluble antibiotic of the aminoglycoside group.

Gentamicin is obtained from cultures of Micromonospora purpurea. It is a mixture of the sulfate salts of gentamicin C₁, C₂, and C_1A. All three components appear to have similar antimicrobial activities. Gentamicin sulfate occurs as a white to buff powder and is soluble in water but insoluble in alcohol. The structural formula is as follows:

Each mL contains: Active: gentamicin sulfate equivalent to 3 mg (0.3%) gentamicin base. Preservative: benzalkonium chloride. Inactives: edetate disodium; polyvinyl alcohol 1.4%; purified water; sodium chloride; sodium phosphate, dibasic; and hydrochloric acid and/or sodium hydroxide to adjust the pH. The solution is an aqueous, buffered solution with a shelf life pH range of 6.5 to 7.5.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

SPL UNCLASSIFIED SECTION

Microbiology: Gentamicin sulfate is active in vitro against many strains of the following micro-organisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

GENTAMICIN SULFATE OPHTHALMIC SOLUTION, USP is contraindicated in patients with known hypersensitivity to any of the components.

WARNINGS

WARNINGS SECTION

NOT FOR INJECTION INTO THE EYE.

GENTAMICIN SULFATE OPHTHALMIC SOLUTION, USP is not for injection. It should never be injected subconjunctivally, nor should it be directly introduced into the anterior chamber of the eye.

PRECAUTIONS

PRECAUTIONS SECTION

General:

GENERAL PRECAUTIONS SECTION

Prolonged use of topical antibiotics may give rise to overgrowth of nonsusceptible microorganisms, including fungi. Bacterial resistance to gentamicin may also develop. If purulent discharge, inflammation or pain becomes aggravated, the patient should discontinue use of the medication and consult a physician.

If irritation or hypersensitivity to any component of the drug develops, the patient should discontinue use of this preparation and appropriate therapy should be instituted.

Information for Patients:

INFORMATION FOR PATIENTS SECTION

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

Carcinogenesis, Mutagenesis, Impairment of Fertility:

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

There are no published carcinogenicity or impairment of fertility studies on gentamicin. Aminoglycoside antibiotics have been found to be non-mutagenic.

Pregnancy:

PREGNANCY SECTION

SPL UNCLASSIFIED SECTION

Pregnancy Category C: Gentamicin has been shown to depress body weights, kidney weights and median glomerular counts in newborn rats when administered systemically to pregnant rats in daily doses approximately 500 times the maximum recommended ophthalmic human dose. There are no adequate and well-controlled studies in pregnant women. Gentamicin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Pediatric Use:

PEDIATRIC USE SECTION

Safety and effectiveness in neonates have not been established.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

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

The most frequently reported adverse reactions are ocular burning and irritation upon drug instillation, non-specific conjunctivitis, conjunctival epithelial defects and conjunctival hyperemia. Other reactions which have occurred rarely are allergic reactions, thrombocytopenic purpura and hallucinations.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Instill one or two drops into the affected eye(s) every four hours. In severe infections, dosage may be increased to as much as two drops every hour.

HOW SUPPLIED

HOW SUPPLIED SECTION

GENTAMICIN SULFATE OPHTHALMIC SOLUTION, USP 0.3% is supplied sterile in white opaque LDPE plastic bottles and tips with white high impact polystyrene (HIPS) caps as follows:

5 mL in 10 mL bottle – NDC 60758-188-05

Note: Store at or below 25°C (77°F). Avoid exposure to excessive heat (40°C/104°F or above).

Rx only

Rev January 2003

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Gentamicin Sulf Ophth 0.3%

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
310467	gentamicin sulfate 0.3 % Ophthalmic Solution	PSN	1
310467	gentamicin 3 MG/ML Ophthalmic Solution	SCD	1
310467	gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic Solution	SY	1
310467	gentamicin sulfate 3 MG/ML Ophthalmic Solution	SY	1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3b7b3a7a-635f-32a3-0c6c-7ad028e3de91	Product name	2	20250107
43025f0d-698c-68da-cec9-ea4261a7ef7a	Product name	2	20250107
d3946667-8212-d1f2-67e1-5643a329bb56	Product name	2	20200403
4ce5dce5-e8a7-e4f6-0059-b527e4307477	Product name	2	20190501
48b05f5d-d2fc-45ab-76e8-3cb5bd44890d	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-187-05	2019-09-24	C162847	48780-1	934fe258-4b69-48b1-e053-8cdaa90a720a	GENTAMICIN SULFATE Ophthalmic Solution, USP 0.3%
21695-187-15	2019-09-24	C162847	48780-1	934fe258-4b69-48b1-e053-8cdaa90a720a	GENTAMICIN SULFATE Ophthalmic Solution, USP 0.3%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-187-05	GENTAMICIN SULFATE	5 mL in 1 BOTTLE, DROPPER	SOLUTION	5		1
21695-187-15	GENTAMICIN SULFATE	15 mL in 1 BOTTLE, DROPPER	SOLUTION	15		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-187	GENTAMICIN SULFATE SOLUTION [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 2 package rows	20101126_d7a27e38-0553-4d4b-8438-fed235e9b989.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-187-05	ML - Milliliter	21695-187	c9328ed0-4711-4732-a4e2-d0e11c2a4c47	1	2012-07-24
21695-187-15	ML - Milliliter	21695-187	5e7a5432-44af-4f31-94bf-c92570fefdbf	1	2012-07-24
60758-188-05	ML - Milliliter	60758-188	d155d9ac-d56c-4938-a7d3-39ee324dd1f5	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
gentamicin sulfate	ACTIVE INGREDIENT	8X7386QRLV	1
gentamicin	ACTIVE MOIETY	T6Z9V48IKG	1
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	1
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	1
hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	1
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	1
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	1
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	1
water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

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

GENTAMICIN SULFATE
gentamicin
edetate disodium
POLYVINYL ALCOHOL
water
sodium chloride
SODIUM PHOSPHATE, DIBASIC
BENZALKONIUM CHLORIDE
hydrochloric acid
sodium hydroxide

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
21695-187	21695-187-05, 21695-187-15
60758-188

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
gentamicin sulfate	8X7386QRLV	ACTIB
edetate disodium	7FLD91C86K	IACT
POLYVINYL ALCOHOL	532B59J990	IACT
water	059QF0KO0R	IACT
sodium chloride	451W47IQ8X	IACT
SODIUM PHOSPHATE, DIBASIC	GR686LBA74	IACT
BENZALKONIUM CHLORIDE	F5UM2KM3W7	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 · 588 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	INJECTION, SOLUTION / SUBARACHNOID	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION / INTRASPINAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	SUSPENSION/ DROPS / OPHTHALMIC	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / SUBCUTANEOUS		1486 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	SOLUTION, CONCENTRATE / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION, SUSPENSION / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRASYNOVIAL	ADJ PH		Exact identifier — unii candidate 174 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 PHOSPHATE, DIBASIC	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	CONCENTRATE / ORAL	17 mg/5ml		Exact identifier — unii candidate 14 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	POWDER, FOR SUSPENSION / ORAL		9 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	ELIXIR / ORAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SYSTEM / IONTOPHORESIS	3.1 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / DENTAL	0.4 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION / ENDOTRACHEAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION/ DROPS / OPHTHALMIC		3 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRA-ARTICULAR		26 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	ENEMA / RECTAL	0.7 %w/w		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
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	PASTE / DENTAL	0.6 %w/w		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	FILM / BUCCAL	0.09 mg		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
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION, SOLUTION / INTRAVASCULAR	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRAPLEURAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	SOLUTION / ORAL		223 mg	Exact identifier — unii candidate 148 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	CREAM / TOPICAL	0.4 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
POLYVINYL ALCOHOL	POLYVINYL ALCOHOL	532B59J990	TABLET, EXTENDED RELEASE / ORAL		96 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	TABLET, EXTENDED RELEASE / ORAL		13 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	POWDER, FOR SUSPENSION / ENDOTRACHEAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION, SOLUTION / INTRAVESICAL		157 mg	Exact identifier — unii candidate 148 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / EPIDURAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRABURSAL	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SOLUTION/ DROPS / OPHTHALMIC	0.13 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	SUSPENSION / INTRATYMPANIC		1 mg	Exact identifier — unii candidate 148 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION / SUBCUTANEOUS		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	CONCENTRATE / ORAL		20 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRACARDIAC		70 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRAVITREAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION, SOLUTION / INTRAVENOUS		1037 mg	Exact identifier — unii candidate 148 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	GEL / OPHTHALMIC		6 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION, POWDER, FOR SOLUTION / INTRATHECAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / AURICULAR (OTIC)	0.8 %w/w		Exact identifier — unii candidate 174 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	INJECTION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / EPIDURAL		3535 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION/ DROPS / AURICULAR (OTIC)	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / PARENTERAL		584 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	TABLET, FILM COATED / ORAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / SUBMUCOSAL		17 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION, SUSPENSION / INTRA-ARTICULAR	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		27 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
POLYVINYL ALCOHOL	POLYVINYL ALCOHOL	532B59J990	SUSPENSION / ORAL		5 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION, SOLUTION / SUBARACHNOID	ADJ PH		Exact identifier — unii candidate 148 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 chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / AURICULAR (OTIC)		18 mg	Exact identifier — unii candidate 134 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	GEL, METERED / TRANSDERMAL		350 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRAVENOUS		2916 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	SOLUTION / INTRATHECAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
hydrochloric acid	HYDROCHLORIC ACID	QTT17582CB	INJECTION / INTRA-ARTERIAL		840 mg	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 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
A062452-001	GENOPTIC	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC			1984-10-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062452-001	GENOPTIC	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	RS	1984-10-10	`f41ea6bd6efb…`

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	A062452-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A062452-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A062452-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A062452-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A062452-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A062452-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A062452-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A062452-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A062452-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A062452-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A062452-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A062452-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A062452-001	AT	1	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	A062452-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A062452-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A062452-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A062452-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A062452-001	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
d7a27e38-0553-4d4b-8438-fed235e9b989			d7a27e38-0553-4d4b-8438-fed235e9b989	2010-09-27	Warnings, Adverse reactions	Exact identifier spl id: d7a27e38-0553-4d4b-8438-fed235e9b989 spl set id: d7a27e38-0553-4d4b-8438-fed235e9b989

Reported adverse events (FAERS/openFDA)#

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