GENTAK ® Gentamicin Sulfate Ophthalmic Ointment USP,0.3%

Manufacturer: Akorn | Akorn Operating Company LLC
Effective date: 2022-01-28
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-05-31 20:42:10

Label at a glance#

ProductGentak

Active ingredientGentamicin Sulfate

Label structure12 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. 06/16

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC 17478-284-35 Akorn Logo

Gentak^®

brand of Gentamicin Sulfate

Ophthalmic Ointment USP, 0.3%

(equivalent to 3 mg gentamicin per gram)

Net Wt 3.5 g (1/8 oz) Sterile

Rx only

Principal Display Panel Text for Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

3.5 g NDC 17478-284-35

Gentak^®

Brand of Gentamicin Sulfate Ophthalmic Ointment USP, 0.3%

(equivalent to 3 mg gentamicin per gram)

Net Wt 3.5 g (1/8 oz.) Sterile Rx only Akorn Logo

Principal Display Panel Text for Carton Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
545236	GENTAK 0.3 % (3 MG/GM) Ophthalmic Ointment	PSN	6
310466	gentamicin sulfate 0.3 % (3 MG/GM) Ophthalmic Ointment	PSN	6
545236	gentamicin 0.003 MG/MG Ophthalmic Ointment [Gentak]	SBD	6
310466	gentamicin 0.003 MG/MG Ophthalmic Ointment	SCD	6
545236	Gentak 0.003 MG/MG Ophthalmic Ointment	SY	6
545236	Gentak 0.3 % Ophthalmic Ointment	SY	6
545236	Gentak 3 MG per 1 GM Ophthalmic Ointment	SY	6
310466	gentamicin (as gentamicin sulfate) 0.3 % Ophthalmic Ointment	SY	6

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
17478-284-35	2024-01-30	C162847	48780-1	1030e365-34b5-111a-e063-dadaa90a10e2	GENTAK ® Gentamicin Sulfate Ophthalmic Ointment USP,0.3%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
17478-284-35	Gentak	1 in 1 CARTON	OINTMENT	1		6
17478-284-35	Gentak	3.5 g in 1 TUBE	OINTMENT	3.5		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17478-284	GENTAK (GENTAMICIN SULFATE) OINTMENT [AKORN]	6	Legacy NDC, 2 package rows	20220702_a357d23d-1f10-44ce-a2fa-a6a5e03e7739.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
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	1
Gentamicin	ACTIVE MOIETY	T6Z9V48IKG	1
Gentamicin Sulfate	INACTIVE INGREDIENT	8X7386QRLV	1
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	1
Mineral Oil	INACTIVE INGREDIENT	T5L8T28FGP	1
Petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	1
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	1

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
17478-284	17478-284-35

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 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

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
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION/ DROPS / OPHTHALMIC	0.01 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	SPRAY / TOPICAL		1379 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	TABLET, EXTENDED RELEASE / ORAL	0.17 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	SUSPENSION / SUBCUTANEOUS	0.16 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	SYSTEM / TRANSDERMAL	6.09 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	TABLET, DELAYED RELEASE / ORAL	5.67 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SUSPENSION / INTRAMUSCULAR	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / SUBCUTANEOUS		22 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	0.4 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	CREAM / TOPICAL		6 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRAMUSCULAR		6 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	CAPSULE / ORAL		7 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	CAPSULE / ORAL		120 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
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SHAMPOO / TOPICAL	0.15 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	LIQUID / TOPICAL	0.1 %w/w		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	ELIXIR / ORAL	200 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	CREAM / VAGINAL		402 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / PARENTERAL		18 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 / NASAL	250 mg		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
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, SUSPENSION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / TOPICAL	0.24 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	TABLET, EXTENDED RELEASE / ORAL	0.12 mg		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
Petrolatum	PETROLATUM	4T6H12BN9U	CREAM, AUGMENTED / TOPICAL	26 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / NASAL	140 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / ORAL	100 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	JELLY / NASAL	250 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SPRAY / NASAL	0.2 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	15 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	DROPS / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / INFILTRATION		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	FILM / TRANSDERMAL	11.42 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	CONCENTRATE / ORAL	2.5 mg/5ml		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	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SOLUTION / INTRAMUSCULAR		5 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	LIQUID / ORAL		162 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	PASTE / TOPICAL	47.5 %w/w		Exact identifier — unii candidate 30 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	GEL / VAGINAL		2 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	TABLET, CHEWABLE / ORAL	1.28 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	OINTMENT / OPHTHALMIC	88.4 %w/w		Exact identifier — unii candidate 18 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, SOLUTION / INTRAMUSCULAR		45 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	FILM, SOLUBLE / BUCCAL		1 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	SYSTEM / TOPICAL	654.36 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
Methylparaben	METHYLPARABEN	A2I8C7HI9T	CONCENTRATE / ORAL		12 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	ENEMA / RECTAL	0.02 %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	INJECTION, SUSPENSION / SUBCUTANEOUS	0.16 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
Propylparaben	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	AEROSOL, FOAM / TOPICAL	7.9 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	SUSPENSION / AURICULAR (OTIC)	0.5 %w/v		Exact identifier — unii candidate 30 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	LIQUID / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 18 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
50c5ed21-5a73-40cb-aa7a-0e1ba3b7bbb4			a357d23d-1f10-44ce-a2fa-a6a5e03e7739	2022-01-28	Warnings, Adverse reactions	Exact identifier spl id: 50c5ed21-5a73-40cb-aa7a-0e1ba3b7bbb4 spl set id: a357d23d-1f10-44ce-a2fa-a6a5e03e7739

Reported adverse events (FAERS/openFDA)#

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