Gentamicin Sulfate Ophthalmic Solution USP, 0.3% (Sterile)

Manufacturer: Physicians Total Care, Inc.
Effective date: 2012-02-27
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 20:14:25

Label at a glance#

ProductGentamicin Sulfate

Active ingredientGENTAMICIN SULFATE

Label structure12 sections

Indications and uses

Gentamicin sulfate ophthalmic solution 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 pneu...

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.

Storage and handling

Storage: Store between 2°- 30°C (36°- 86°F). Avoid exposure to excessive heat. KEEP OUT OF REACH OF CHILDREN. Revised August 2007 Bausch & Lomb Incorporated Tampa, FL 33637 ©Bausch & Lomb Incorporated Revised August 2007 Additional barcode labeling by: Physicians Total Care, Inc. Tulsa, Oklahoma 74146

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Rx only

DESCRIPTION:

DESCRIPTION SECTION

Gentamicin Sulfate Ophthalmic Solution, is a sterile, aqueous solution buffered to approximately pH 7.0 and formulated for ophthalmic use.

EACH mL CONTAINS:

ACTIVE: Gentamicin Sulfate (equivalent to 3 mg gentamicin).

INACTIVES: Dibasic Sodium Phosphate, Sodium Chloride, Monobasic Sodium Phosphate, Purified Water. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH (6.5 - 7.5).

PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%.

Gentamicin is an aminoglycoside antibiotic obtained from cultures of Micromonospora purpurea. It is a mixture of the sulfate salts of Gentamicin C₁, C₂, C_1a and C_2a. All three components appear to have similar antimicrobial activity.

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

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 solution is contraindicated in patients with known hypersensitivity to any of its components.

WARNINGS:

WARNINGS SECTION

NOT FOR INJECTION INTO THE EYE.

Gentamicin sulfate ophthalmic solution 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 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.

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

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.

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

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 in a plastic bottle with a controlled drop tip in the following sizes:

5 mL - NDC 54868-6745-1

15 mL - NDC 54868-6745-2

NOT FOR INJECTION

FOR OPHTHALMIC USE ONLY

DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT.

STORAGE AND HANDLING SECTION

Storage: Store between 2°- 30°C (36°- 86°F). Avoid exposure to excessive heat.

KEEP OUT OF REACH OF CHILDREN.

Revised August 2007

Bausch & Lomb Incorporated
Tampa, FL 33637
©Bausch & Lomb Incorporated

Revised August 2007

Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Gentamicin Sulfate Ophthalmic Solution USP, 0.3% (sterile)

Rx only

DailyMed RxNorm Mappings#

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

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
54868-6745-1	2019-09-24	C162847	48780-1	9350213a-459b-c013-e053-90daa90a1393	Gentamicin Sulfate Ophthalmic Solution USP, 0.3% (Sterile)
54868-6745-2	2019-09-24	C162847	48780-1	9350213a-459b-c013-e053-90daa90a1393	Gentamicin Sulfate Ophthalmic Solution USP, 0.3% (Sterile)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
54868-6745-1	Gentamicin Sulfate	1 in 1 CARTON	SOLUTION/ DROPS	1	3
54868-6745-1	Gentamicin Sulfate	5 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	5	3
54868-6745-2	Gentamicin Sulfate	15 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	15	3
54868-6745-2	Gentamicin Sulfate	1 in 1 CARTON	SOLUTION/ DROPS	1	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54868-6745	GENTAMICIN SULFATE SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	3	4 package rows	20120306_fcb5baef-4760-4bb3-88dd-e3c3e3bb1a5d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54868-6745-1	ML - Milliliter	54868-6745	16aa7333-b016-4265-a757-02ac4bb2040c	1	2012-07-24
54868-6745-2	ML - Milliliter	54868-6745	6b866b10-d652-42f2-98ea-1d992deef0ec	1	2012-07-24
24208-580-60	ML - Milliliter	24208-580	462515c7-1366-46c5-87db-5b20a94dd6c9	1	2012-07-24
24208-580-64	ML - Milliliter	24208-580	d1064568-058d-41df-b518-a1284803ebfc	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
GENTAMICIN SULFATE	ACTIVE INGREDIENT	8X7386QRLV	3
GENTAMICIN	ACTIVE MOIETY	T6Z9V48IKG	3
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	3
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	3
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	3
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	3
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	3
SODIUM PHOSPHATE, MONOBASIC	INACTIVE INGREDIENT	3980JIH2SW	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	3

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

Gentamicin Sulfate
GENTAMICIN
BENZALKONIUM CHLORIDE
SODIUM PHOSPHATE, DIBASIC
HYDROCHLORIC ACID
SODIUM PHOSPHATE, MONOBASIC
WATER
SODIUM CHLORIDE
SODIUM HYDROXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54868-6745	54868-6745-1, 54868-6745-2
24208-580

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
GENTAMICIN SULFATE	8X7386QRLV	ACTIM
BENZALKONIUM CHLORIDE	F5UM2KM3W7	IACT
SODIUM PHOSPHATE, DIBASIC	GR686LBA74	IACT
HYDROCHLORIC ACID	QTT17582CB	IACT
SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	IACT
WATER	059QF0KO0R	IACT
SODIUM CHLORIDE	451W47IQ8X	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 1 · 14 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM PHOSPHATE, MONOBASIC	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	SYSTEM / IONTOPHORESIS	14.2 mg		Exact identifier — unii candidate 9 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
SODIUM PHOSPHATE, MONOBASIC	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	SOLUTION / ORAL	25 mg/5ml		Exact identifier — unii candidate 9 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION/ DROPS / OPHTHALMIC		1 mg	Exact identifier — unii+route+dosage form
SODIUM PHOSPHATE, MONOBASIC	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	INJECTION / INTRAMUSCULAR		161 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	SOLUTION/ DROPS / OPHTHALMIC	ADJ PH		Exact identifier — unii+route+dosage form
SODIUM PHOSPHATE, MONOBASIC	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	13.2 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	INJECTION, SUSPENSION / SUBCUTANEOUS	0.07 %w/v		Exact identifier — unii candidate 9 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	SUSPENSION / OPHTHALMIC	0.43 %w/w		Exact identifier — unii+route
SODIUM PHOSPHATE, MONOBASIC	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	SYSTEM / TOPICAL	14.2 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION/ DROPS / OPHTHALMIC	ADJ PH		Exact identifier — unii+route+dosage form
SODIUM PHOSPHATE, MONOBASIC	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	INJECTION / INTRAVENOUS		161 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION/ DROPS / OPHTHALMIC		55 mg	Exact identifier — unii+route+dosage form
SODIUM PHOSPHATE, MONOBASIC	SODIUM PHOSPHATE, MONOBASIC	3980JIH2SW	TABLET / ORAL		2 mg	Exact identifier — unii candidate 9 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
A064048-001	GENTAMICIN SULFATE	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT		1994-05-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A064048-001	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	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064048-001	GENTAMICIN SULFATE	EQ 0.3% BASE	SOLUTION/DROPS / OPHTHALMIC	AT	1994-05-11	`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	A064048-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A064048-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064048-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064048-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064048-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064048-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064048-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064048-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064048-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064048-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064048-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064048-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064048-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064048-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064048-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064048-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064048-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064048-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064048-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064048-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064048-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064048-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064048-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064048-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064048-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064048-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064048-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064048-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064048-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064048-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064048-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064048-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064048-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064048-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064048-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064048-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064048-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064048-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064048-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064048-001	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gentamicin Sulfate	GENTAMICIN SULFATE	Bausch & Lomb Incorporated	41d01350-5c4b-42fc-be5f-986ceec02bd3	2024-07-22	Warnings, Adverse reactions	Exact identifier ndc (product): 24208-580
3608af1c-615a-4829-90bd-4a7c84a3a8b8			fcb5baef-4760-4bb3-88dd-e3c3e3bb1a5d	2012-02-27	Warnings, Adverse reactions	Exact identifier spl id: 3608af1c-615a-4829-90bd-4a7c84a3a8b8 spl set id: fcb5baef-4760-4bb3-88dd-e3c3e3bb1a5d

Reported adverse events (FAERS/openFDA)#

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