GENTAK ® Gentamicin Sulfate Ophthalmic Ointment USP,03%

Manufacturer: Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
Effective date: 2012-10-17
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 5000
Source: legacy-cache
Hydrated at: 2026-08-02 01:44:57

Label at a glance#

ProductGentak

Active ingredientGENTAMICIN SULFATE

Label structure11 sections

Indications and uses

Gentamicin sulfate ophthalmic ointment is indicated in the topical treatment of ocular bacterial infections including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharonconjunctivitis: acute meibomianitis, and dacryocystitis, caused by susceptible strains of the following microorganisms: Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus p...

Dosage and administration

Apply a small amount (approximately 1/2 inch ribbon) of ointment to the affected eye(s) two or three times a day.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Sterile

Rx only

DESCRIPTION

DESCRIPTION SECTION

GENTAK^® Gentamicin sulfate is a water soluble antibiotic of the aminoglycoside group.

Gentamicin sulfate ophthalmic ointment is a sterile ointment for ophthalmic use. Each gram contains gentamicin sulfate equivalent to 3 mg gentamicin in a base of white petrolatum and mineral oil, with methylparaben and propylparaben as preservatives.

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 and insoluble in alcohol. The structural formula is as follows:

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

MICROBIOLOGY SECTION

Microbiology: Gentamicin sulfate is active in vitro against many strains of the following microorganisms:

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

Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Gentamicin sulfate ophthalmic ointment is con-traindicated in patients with known hypersensitivity to any of the components.

WARNINGS

WARNINGS SECTION

NOT FOR INJECTION INTO THE EYE.

Gentamicin sulfate ophthalmic ointment 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 PRECAUTIONS SECTION

General: Prolonged use of topical antibiotics may give rise to overgrowth of nonsusceptible organisms 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.

Ophthalmic ointments may retard corneal healing.

INFORMATION FOR PATIENTS SECTION

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

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

Carcinogenesis, Mutagenesis, Impairment of Fertility: There are no published carcinogenicity or impairment of fertility studies on gentamicin. Aminoglycoside antibiotics have been found to be non-mutagenic.

PREGNANCY SECTION

Pregnancy: 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 SECTION

Pediatric Use: 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 adverse reactions which have occurred rarely are allergic reactions, thrombocytopenic purpura and hallucinations.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Apply a small amount (approximately 1/2 inch ribbon) of ointment to the affected eye(s) two or three times a day.

HOW SUPPLIED

HOW SUPPLIED SECTION

GENTAK^® Gentamicin sulfate ophthalmic ointment USP, 0.3% is supplied in 3.5 g tube, box of one.

(NDC 17478-284-35)

STORAGE AND HANDLING SECTION

STORAGE: Store at 2° to 30°C (36° to 86°F).

Akorn
Manufactured by: Akorn, Inc.
Lake Forest, IL 60045
GKO00N Rev. 09/08

Image of Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of Label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49999-159-35	GM - Gram	49999-159	95c53254-0508-4442-b1c1-b3b82938e536	1	2012-07-24
17478-284-35	GM - Gram	17478-284	89095929-33e3-404b-a9bc-e49509773ce9	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
GENTAMICIN SULFATE	ACTIVE INGREDIENT	8X7386QRLV	5000
GENTAMICIN	ACTIVE MOIETY	T6Z9V48IKG	5000
GENTAMICIN SULFATE	INACTIVE INGREDIENT	8X7386QRLV	5000
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	5000
Mineral Oil	INACTIVE INGREDIENT	T5L8T28FGP	5000
Petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	5000
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	5000

Products#

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

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

Gentak
Gentamicin Sulfate
GENTAMICIN
Methylparaben
Propylparaben
Petrolatum
Mineral Oil

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
49999-159	49999-159-35
17478-284

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
GENTAMICIN SULFATE	8X7386QRLV	ACTIM
Methylparaben	A2I8C7HI9T	IACT
Propylparaben	Z8IX2SC1OH	IACT
Petrolatum	4T6H12BN9U	IACT
Mineral Oil	T5L8T28FGP	IACT
GENTAMICIN SULFATE	8X7386QRLV	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 4 · 195 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Petrolatum	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL		4213 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	FILM / BUCCAL		1 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	TABLET / ORAL	113.75 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / PARENTERAL		30 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	TABLET, FILM COATED / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	JELLY / NASAL	140 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SHAMPOO / TOPICAL	0.15 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	CAPSULE, EXTENDED RELEASE / ORAL	0.07 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SPRAY / TOPICAL	0.8 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / PERIDURAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	ELIXIR / ORAL	200 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	FILM, SOLUBLE / BUCCAL		1 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	EMULSION / TOPICAL	0.06 %w/w		Exact identifier — unii candidate 68 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	LIQUID / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	POWDER, FOR SUSPENSION / ORAL		75 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	CAPSULE / ORAL		120 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	JELLY / TOPICAL		180 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	PASTE / TOPICAL	47.5 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	ELIXIR / ORAL	800 mg		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	SOLUTION / INTRAMUSCULAR	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, SUSPENSION / SUBCUTANEOUS	0.16 %w/v		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
Methylparaben	METHYLPARABEN	A2I8C7HI9T	DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	CAPSULE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / SOFT TISSUE	0.15 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	TABLET / ORAL	3.5 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	GEL / TOPICAL		24 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	OINTMENT / VAGINAL		4084 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	SPRAY / TOPICAL		1379 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	TABLET, COATED / ORAL	1.5 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RESPIRATORY (INHALATION)	0.03 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / INTRAMUSCULAR		45 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	CREAM / VAGINAL		22 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRAMUSCULAR		6 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SUPPOSITORY / VAGINAL	NA		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
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION, CONCENTRATE / ORAL	1 mg/1ml		Exact identifier — unii candidate 79 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	POWDER, FOR SUSPENSION / ORAL		8 mg	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
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SUSPENSION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRAVENOUS		6 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	DROPS / ORAL	1 mg/1ml		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
Mineral Oil	MINERAL OIL	T5L8T28FGP	FILM, EXTENDED RELEASE / TRANSDERMAL	34 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / ORAL		388 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION/ DROPS / OPHTHALMIC	0.01 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SPRAY / NASAL	0.2 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
Methylparaben	METHYLPARABEN	A2I8C7HI9T	JELLY / NASAL	250 mg		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
Methylparaben	METHYLPARABEN	A2I8C7HI9T	GEL / VAGINAL		8 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	POWDER / ORAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	SOAP / TOPICAL	0.82 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	POWDER / ORAL	NA		Exact identifier — unii candidate 79 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
A064093-001	GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 0.3% BASE	OINTMENT / OPHTHALMIC			1995-08-31

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	A064093-001	GENTAMICIN SULFATE	EQ 0.3% BASE	OINTMENT / OPHTHALMIC			1995-08-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A064093-001	GENTAMICIN SULFATE	EQ 0.3% BASE	OINTMENT / OPHTHALMIC			1995-08-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064093-001	GENTAMICIN SULFATE	EQ 0.3% BASE	OINTMENT / OPHTHALMIC			1995-08-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064093-001	GENTAMICIN SULFATE	EQ 0.3% BASE	OINTMENT / OPHTHALMIC			1995-08-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064093-001	GENTAMICIN SULFATE	EQ 0.3% BASE	OINTMENT / OPHTHALMIC			1995-08-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064093-001	GENTAMICIN SULFATE	EQ 0.3% BASE	OINTMENT / OPHTHALMIC			1995-08-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064093-001	GENTAMICIN SULFATE	EQ 0.3% BASE	OINTMENT / OPHTHALMIC			1995-08-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064093-001	GENTAMICIN SULFATE	EQ 0.3% BASE	OINTMENT / OPHTHALMIC			1995-08-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064093-001	GENTAMICIN SULFATE	EQ 0.3% BASE	OINTMENT / OPHTHALMIC			1995-08-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064093-001	GENTAMICIN SULFATE	EQ 0.3% BASE	OINTMENT / OPHTHALMIC			1995-08-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064093-001	GENTAMICIN SULFATE	EQ 0.3% BASE	OINTMENT / OPHTHALMIC			1995-08-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064093-001	GENTAMICIN SULFATE	EQ 0.3% BASE	OINTMENT / OPHTHALMIC			1995-08-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064093-001	GENTAMICIN SULFATE	EQ 0.3% BASE	OINTMENT / OPHTHALMIC			1995-08-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064093-001	GENTAMICIN SULFATE	EQ 0.3% BASE	OINTMENT / OPHTHALMIC			1995-08-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064093-001	GENTAMICIN SULFATE	EQ 0.3% BASE	OINTMENT / OPHTHALMIC			1995-08-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064093-001	GENTAMICIN SULFATE	EQ 0.3% BASE	OINTMENT / OPHTHALMIC			1995-08-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064093-001	GENTAMICIN SULFATE	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	AT	RS	1995-08-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064093-001	GENTAMICIN SULFATE	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	AT	RS	1995-08-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064093-001	GENTAMICIN SULFATE	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	AT	RS	1995-08-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064093-001	GENTAMICIN SULFATE	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	AT	RS	1995-08-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064093-001	GENTAMICIN SULFATE	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	AT	RS	1995-08-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064093-001	GENTAMICIN SULFATE	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	AT	RS	1995-08-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064093-001	GENTAMICIN SULFATE	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	AT	RS	1995-08-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064093-001	GENTAMICIN SULFATE	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	AT	RS	1995-08-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064093-001	GENTAMICIN SULFATE	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	AT	RS	1995-08-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064093-001	GENTAMICIN SULFATE	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	AT	RS	1995-08-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064093-001	GENTAMICIN SULFATE	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	AT	RS	1995-08-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064093-001	GENTAMICIN SULFATE	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	AT	RS	1995-08-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064093-001	GENTAMICIN SULFATE	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	AT	RS	1995-08-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064093-001	GENTAMICIN SULFATE	EQ 0.3% BASE	OINTMENT / OPHTHALMIC			1995-08-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064093-001	GENTAMICIN SULFATE	EQ 0.3% BASE	OINTMENT / OPHTHALMIC			1995-08-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064093-001	GENTAMICIN SULFATE	EQ 0.3% BASE	OINTMENT / OPHTHALMIC			1995-08-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064093-001	GENTAMICIN SULFATE	EQ 0.3% BASE	OINTMENT / OPHTHALMIC			1995-08-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064093-001	GENTAMICIN SULFATE	EQ 0.3% BASE	OINTMENT / OPHTHALMIC			1995-08-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064093-001	GENTAMICIN SULFATE	EQ 0.3% BASE	OINTMENT / OPHTHALMIC			1995-08-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064093-001	GENTAMICIN SULFATE	EQ 0.3% BASE	OINTMENT / OPHTHALMIC			1995-08-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064093-001	GENTAMICIN SULFATE	EQ 0.3% BASE	OINTMENT / OPHTHALMIC			1995-08-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064093-001	GENTAMICIN SULFATE	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	AT	RS	1995-08-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064093-001	GENTAMICIN SULFATE	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	AT	RS	1995-08-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064093-001	GENTAMICIN SULFATE	EQ 0.3% BASE	OINTMENT / OPHTHALMIC	AT	RS	1995-08-31	`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	A064093-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064093-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064093-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064093-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064093-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064093-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064093-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064093-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064093-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064093-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064093-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064093-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064093-001	AT	1	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	A064093-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064093-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064093-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064093-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064093-001	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
ee3107f7-0cae-42a8-925f-d412658cf48f			a10572d0-ed48-4bf2-87d3-cdc626ce00bf	2019-11-13	Warnings, Adverse reactions	Exact identifier spl set id: a10572d0-ed48-4bf2-87d3-cdc626ce00bf

Reported adverse events (FAERS/openFDA)#

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