NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN

Overview

Brand name

NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN

Generic name

neomycin sulfate, polymyxin b sulfate and gramicidin

Dosage form

Solution/ Drops

Route

Ophthalmic

Marketing category

ANDA · ANDA

Labeler

Bausch & Lomb Incorporated

Product type

Human Prescription Drug

DEA schedule

Not scheduled

Active ingredients

3

NDC product codes

2

Packages

2

Data completeness

76% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Gramicidin	.025 mg/mL	310594	—
Neomycin Sulfate	1.75 mg/mL	204602	View
Polymyxin B Sulfate	10000 [USP'U]/mL	204602	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Solution/ Drops

Route of administration

Ophthalmic

Presentations

4

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory

Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class	Type	Browse
Aminoglycoside Antibacterial [EPC]	EPC	All 66 members
Aminoglycosides [CS]	CS	All 66 members
Polymyxin-class Antibacterial [EPC]	EPC	All 55 members
Polymyxins [CS]	CS	All 55 members

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

064047

Application type

ANDA · Abbreviated New Drug Application

Approval date

January 31, 1996

Sponsor

BAUSCH AND LOMB INC

Products on application

1

Submissions recorded

15

Products approved under application 064047.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
064047-001	NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN	SOLUTION/DROPS		GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	Prescription	AT	RS

Therapeutic equivalence

Source: Orange Book

TE code

AT

Reference Listed Drug

No

Reference Standard

Yes

What this rating means: Therapeutically equivalent — bioequivalence demonstrated (topical dermatological products)

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA

Most recent submissions on application 064047.
Type	No.	Action	Status	Date	Review
Supplement	13	Manufacturing (CMC)	Approved	November 27, 2001	—
Supplement	14	Manufacturing (CMC)	Approved	October 30, 2001	—
Supplement	12	Manufacturing (CMC)	Approved	April 30, 2001	—
Supplement	11	Manufacturing (CMC)	Approved	March 7, 2001	—
Supplement	10	Manufacturing (CMC)	Approved	June 27, 2000	—
Supplement	8	Manufacturing (CMC)	Approved	May 18, 2000	—
Supplement	9	Manufacturing (CMC)	Approved	April 28, 2000	—
Supplement	7	Manufacturing (CMC)	Approved	June 7, 1999	—
Supplement	6	Manufacturing (CMC)	Approved	February 19, 1999	—
Supplement	5	Manufacturing (CMC)	Approved	November 19, 1998	—
Supplement	4	Manufacturing (CMC)	Approved	October 22, 1998	—
Supplement	3	Manufacturing (CMC)	Approved	February 24, 1998	—
Supplement	2	Manufacturing (CMC)	Approved	February 24, 1998	—
Supplement	1	Manufacturing (CMC)	Approved	October 20, 1997	—
Original application	1		Approved	January 31, 1996	—

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260204). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN PRESCRIPTION DRUG · 20260204 HUMAN PRESCRIPTION DRUG · 20240918

Indications and Usage

openFDA Drug Labeling

INDICATIONS AND USAGE Neomycin and polymyxin B sulfates and gramicidin ophthalmic solution is indicated for the topical treatment of superficial infections of the external eye and its adnexa caused by susceptible bacteria. Such infections encompass conjunctivitis, keratitis and keratoconjunctivitis, blepharitis and blepharoconjunctivitis.

Dosage and Administration

openFDA Drug Labeling

DOSAGE AND ADMINISTRATION Instill one or two drops into the affected eye every 4 hours for 7 to 10 days. In severe infections, dosage may be increased to as much as two drops every hour. donot

Contraindications

openFDA Drug Labeling

CONTRAINDICATIONS This product is contraindicated in those persons who have shown hypersensitivity to any of its components.

Warnings

openFDA Drug Labeling

WARNINGS NOT FOR INJECTION INTO THE EYE. This product should never be directly introduced into the anterior chamber of the eye or injected subconjunctivally. Topical antibiotics, particularly neomycin sulfate, may cause cutaneous sensitization. A precise incidence of hypersensitivity reactions (primarily skin rash) due to topical antibiotics is not known. The manifestations of sensitization to topical antibiotics are usually itching, reddening and edema of the conjunctiva and eyelid. A sensitization reaction may manifest simply as a failure to heal. During long-term use of topical antibiotic products, periodic examination for such signs is advisable, and the patient should be told to discontinue the product if they are observed. Symptoms usually subside quickly on withdrawing the medication. Applications of products containing these ingredients should be avoided for the patient thereafter (see PRECAUTIONS : Error! Hyperlink reference not valid. ).

Adverse Reactions

openFDA Drug Labeling

ADVERSE REACTIONS Adverse reactions have occurred with the anti-infective components of this product. The exact incidence is not known. Reactions occurring most often are allergic reactions including itching, swelling, and conjunctival erythema (see WARNINGS ). More serious hypersensitivity reactions, including anaphylaxis, have been reported rarely. Local irritation on instillation has also been reported. To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Description

openFDA Drug Labeling

DESCRIPTION Neomycin and polymyxin B sulfates and gramicidin ophthalmic solution, USP is a sterile antimicrobial solution for ophthalmic use. Each mL contains: Actives: neomycin sulfate, (equivalent to 1.75 mg neomycin base), polymyxin B sulfate equal to 10,000 polymyxin B units, gramicidin, 0.025 mg; Inactives: sodium chloride, alcohol (0.5%), Poloxamer 188, propylene glycol, purified water. Hydrochloric acid and/or ammonium hydroxide may be added to adjust pH (4.7-6.0). Preservative: thimerosal 0.001%. Neomycin Sulfate is the sulfate salt of neomycin B and C, which are produced by the growth of Streptomyces fradiae Waksman (Fam. Streptomycetaceae). It has a potency equivalent of not less than 600 micrograms of neomycin base per milligram, calculated on an anhydrous basis. The structural formulae are: Polymyxin B Sulfate is the sulfate salt of polymyxin B 1 and B 2 which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae). It has a potency of not less than 6,000 polymyxin B units per milligram, calculated on an anhydrous basis. The structural formulae are: Gramicidin (also called gramicidin D) is a mixture of three pairs of antibacterial substances (Gramicidin A, B and C) produced by the growth of Bacillus brevis Dubos (Fam. Bacillaceae). It has a potency of not less than 900 mcg of standard gramicidin per mg. The structural formulae are: Neomycin Sulfate (structural formula) Polymyxin B Sulfate (structural formula) Gramicidin (structural formula)

How Supplied / Storage and Handling

openFDA Drug Labeling

HOW SUPPLIED Neomycin and polymyxin B sulfates and gramicidin ophthalmic solution, USP is supplied in a plastic squeeze bottle with a controlled drop tip and a natural cap in the following size: NDC 24208-790-62 - 10 mL Storage: Store between 15°C to 25°C (59°F to 77°F). PROTECT FROM LIGHT. Keep out of reach of children.

Adverse event reports

Source: openFDA FAERS

4,875

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: POLYMYXIN B SULFATE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
50090-0247-0	50090-0247	A-S Medication Solutions	1 BOTTLE, DROPPER in 1 CARTON (50090-0247-0) / 10 mL in 1 BOTTLE, DROPPER	June 29, 2016
24208-790-62	24208-790	Bausch & Lomb Incorporated	1 BOTTLE, DROPPER in 1 CARTON (24208-790-62) / 10 mL in 1 BOTTLE, DROPPER	January 31, 1996
50090-0247	50090-0247	A-S Medication Solutions	—	January 31, 1996
24208-790	24208-790	Bausch & Lomb Incorporated	—	January 31, 1996

Sources for this page

Every dataset that contributed a fact to this page.
Dataset	Agency	Used for
NDC Directory	FDA	Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA	FDA	Application, sponsor, submissions, review documents, marketing status
Orange Book	FDA	Therapeutic equivalence codes, reference drug flags, patents, exclusivity
Drug Labeling	FDA / NLM	Prescribing information reproduced above
FAERS	FDA	Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.