Triple Antibiotic

Manufacturer: Phoenix Pharmaceutical, Inc. | Bausch & Lomb Incorporated
Effective date: 2010-11-04
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 20:10:30

Label at a glance#

ProductTriple Antibiotic

Active ingredientNEOMYCIN SULFATE, POLYMYXIN B SULFATE, BACITRACIN ZINC

Label structure11 sections

Indications and uses

Neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment 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

Apply the ointment every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Rx only

DESCRIPTION:

DESCRIPTION SECTION

Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment USP is a sterile antimicrobial ointment for ophthalmic use.

Each Gram Contains:

ACTIVES: Neomycin Sulfate (equivalent to 3.5 mg neomycin base), Polymyxin B Sulfate equivalent to 10,000 polymyxin B units, and Bacitracin Zinc equivalent to 400 bacitracin units; INACTIVES: White Petrolatum, Mineral Oil.

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 standard per milligram, calculated on an anhydrous basis. The structural formulae are:

Polymyxin B sulfate is the sulfate salt of polymyxin B₁ and B₂ 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:

Polymyxin B Sulfate (structural formula)

Bacitracin zinc is the zinc salt of bacitracin, a mixture of related cyclic polypeptides (mainly bacitracin A) produced by the growth of an organism of the licheniformis group of Bacillus subtilis var Tracy. It has a potency of not less than 40 bacitracin units per milligram.

The structural formula for bacitracin A is:

CLINICAL PHARMACOLOGY:

CLINICAL PHARMACOLOGY SECTION

A wide range of antibacterial action is provided by the overlapping spectra of neomycin, polymyxin B sulfate, and bacitracin.

Neomycin is bactericidal for many gram-positive and gram-negative organisms. It is an aminoglycoside antibiotic which inhibits protein synthesis by binding with ribosomal RNA and causing misreading of the bacterial genetic code.

Polymyxin B is bactericidal for a variety of gram-negative organisms. It increases the permeability of the bacterial cell membrane by interacting with the phospholipid components of the membrane.

Bacitracin is bactericidal for a variety of gram-positive and gram-negative organisms. It interferes with bacterial cell wall synthesis by inhibition of the regeneration of phospholipid receptors involved in peptidoglycan synthesis.

Microbiology: Neomycin sulfate, polymyxin B sulfate and bacitracin zinc together are considered active against the following microorganisms: Staphylococcus aureus, streptococci including Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella-Enterobacter species, Neisseria species, and Pseudomonas aeruginosa. The product does not provide adequate coverage against Serratia marcescens.

INDICATIONS AND USAGE:

INDICATIONS & USAGE SECTION

CONTRAINDICATIONS:

CONTRAINDICATIONS SECTION

Neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment is contraindicated in those individuals who have shown hypersensitivity to any of its components.

WARNINGS:

WARNINGS SECTION

NOT FOR INJECTION INTO THE EYE.

Neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment should never be directly introduced into the anterior chamber of the eye. Ophthalmic ointments may retard corneal wound healing.

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. Application of products containing these ingredients should be avoided for the patient thereafter (see PRECAUTIONS: General).

PRECAUTIONS:

PRECAUTIONS SECTION

General

GENERAL PRECAUTIONS SECTION

As with other antibiotic preparations, prolonged use of neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment may result in overgrowth of nonsusceptible organisms including fungi. If superinfection occurs, appropriate measures should be initiated.

Bacterial resistance to neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment may also develop. If purulent discharge, inflammation, or pain becomes aggravated, the patient should discontinue use of the medication and consult a physician.

There have been reports of bacterial keratitis associated with the use of topical ophthalmic products in multiple-dose containers which have been inadvertently contaminated by patients, most of whom had a concurrent corneal disease or a disruption of the ocular epithelial surface (see PRECAUTIONS: Information for Patients).

Allergic cross-reactions may occur which could prevent the use of any or all of the following antibiotics for the treatment of future infections: kanamycin, paromomycin, streptomycin, and possibly gentamicin.

Information for Patients:

INFORMATION FOR PATIENTS SECTION

Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, eyelid, fingers, or any other surface.

The use of this product by more than one person may spread infection.

Patients should also be instructed that ocular products, if handled improperly, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated products (see PRECAUTIONS: General).

If the condition persists or gets worse, or if a rash or allergic reaction develops, the patient should be advised to stop use and consult a physician. Do not use this product if you are allergic to any of the listed ingredients.

Keep tightly closed when not in use. Keep out of reach of children.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

Long-term studies in animals to evaluate carcinogenic or mutagenic potential have not been conducted with polymyxin B sulfate or bacitracin. Treatment of cultured human lymphocytes in vitro with neomycin increased the frequency of chromosome aberrations at the highest concentration (80 mcg/mL) tested; however, the effects of neomycin on carcinogenesis and mutagenesis in humans are unknown.

Polymyxin B has been reported to impair the motility of equine sperm, but its effects on male or female fertility are unknown. No adverse effects on male or female fertility, litter size or survival were observed in rabbits given bacitracin zinc 100 gm/ton of diet.

Pregnancy;

PREGNANCY SECTION

Teratogenic Effects:

TERATOGENIC EFFECTS SECTION

Pregnancy Category C. Animal reproduction studies have not been conducted with neomycin sulfate, polymyxin B sulfate, or bacitracin. It is also not known whether neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment should be given to a pregnant woman only if clearly needed.

Nursing Mothers:

NURSING MOTHERS SECTION

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment is administered to a nursing woman.

Pediatric Use:

PEDIATRIC USE SECTION

Safety and effectiveness in pediatric patients have not been established.

ADVERSE REACTIONS:

ADVERSE REACTIONS SECTION

Adverse reactions have occurred with the anti-infective components of neomycin and polymyxin B sulfates and bacitracin zinc ophthalmic ointment. The exact incidence is not known. Reactions occurring most often are allergic sensitization 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.

DOSAGE AND ADMINISTRATION:

DOSAGE & ADMINISTRATION SECTION

Apply the ointment every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection.

HOW SUPPLIED:

HOW SUPPLIED SECTION

Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment USP is supplied in a 3.5 g tube with an ophthalmic tip.

Prod. No. 03534

DO NOT USE IF CAP AND NECKRING ARE NOT INTACT.

FOR OPHTHALMIC USE ONLY

Storage:

STORAGE AND HANDLING SECTION

Store between 15° - 30°C (59°- 86°F).

KEEP OUT OF REACH OF CHILDREN.

Revised November 2007

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

9113600 (Folded)
9113700 (Flat)

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 57319-343-25

Triple Antibiotic Ointment

Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment USP (Sterile)

Net Wt. 3.5g Rx only

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
308493	bacitracin zinc 400 UNT / neomycin sulfate 3.5 MG / polymyxin B sulfate 10,000 UNT per GM Ophthalmic Ointment	PSN	1
308493	bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG Ophthalmic Ointment	SCD	1
308493	bacitracin 0.4 UNT/MG / neomycin 0.35 % / polymyxin B 10 UNT/MG Ophthalmic Ointment	SY	1
308493	bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT per GM Ophthalmic Ointment	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
BACITRACIN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813
NEOMYCIN Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813
POLYMYXIN B Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
99e684e6-f435-feb8-d2bb-3a546f1cb768	Product name	2	20161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0c	Product name	1	20160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4	Product name	1	20150819
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
b6082387-f592-1148-0844-bd068fd213fb	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57319-343-25	2019-10-29	C162847	48780-1	960f7f55-c5ab-8e05-e053-dbdaa90a074a	Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment USP (Sterile)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57319-343-25	Triple Antibiotic	1 in 1 CARTON	OINTMENT	1		1
57319-343-25	Triple Antibiotic	3.5 g in 1 TUBE	OINTMENT	3.5		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57319-343	TRIPLE ANTIBIOTIC (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND BACITRACIN ZINC) OINTMENT [PHOENIX PHARMACEUTICAL, INC.]	1	Legacy NDC, 2 package rows	20101122_f7504b22-2d9e-4e2c-a308-1469bd5a1bab.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
BACITRACIN ZINC	ACTIVE INGREDIENT	89Y4M234ES	1
NEOMYCIN SULFATE	ACTIVE INGREDIENT	057Y626693	1
POLYMYXIN B SULFATE	ACTIVE INGREDIENT	19371312D4	1
BACITRACIN	ACTIVE MOIETY	58H6RWO52I	1
NEOMYCIN	ACTIVE MOIETY	I16QD7X297	1
POLYMYXIN B	ACTIVE MOIETY	J2VZ07J96K	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	1

Products#

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

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

Triple Antibiotic
Neomycin sulfate, Polymyxin B Sulfate and Bacitracin Zinc
NEOMYCIN SULFATE
NEOMYCIN
POLYMYXIN B SULFATE
POLYMYXIN B
BACITRACIN ZINC
BACITRACIN
MINERAL OIL
PETROLATUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
57319-343	57319-343-25

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
NEOMYCIN SULFATE	057Y626693	ACTIB
POLYMYXIN B SULFATE	19371312D4	ACTIB
BACITRACIN ZINC	89Y4M234ES	ACTIB
MINERAL OIL	T5L8T28FGP	IACT
PETROLATUM	4T6H12BN9U	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 · 48 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUPPOSITORY / VAGINAL	30 mg		Exact identifier — unii candidate 30 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	SUPPOSITORY / RECTAL	NA		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
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET, DELAYED RELEASE / ORAL	5.67 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CAPSULE / ORAL		120 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OINTMENT / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	PASTE / DENTAL	95 %w/w		Exact identifier — unii candidate 30 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	TABLET / ORAL	113.75 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OINTMENT / OPHTHALMIC	59.5 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL		4213 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	PASTE / TOPICAL	47.5 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	EMULSION / TOPICAL	7.8 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	LOTION / TOPICAL		1428 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OIL / TOPICAL	43.29 %v/v		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CAPSULE, EXTENDED RELEASE / ORAL		120 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SUPPOSITORY / VAGINAL	27 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	GEL / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LOTION / TOPICAL	25 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CREAM / VAGINAL		402 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CAPSULE / VAGINAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SOAP / TOPICAL	0.82 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUSPENSION / OPHTHALMIC	0.1 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SPRAY / TOPICAL		1379 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SOAP / TOPICAL	0.85 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET, CHEWABLE / ORAL		6 mg	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
MINERAL OIL	MINERAL OIL	T5L8T28FGP	FILM, EXTENDED RELEASE / TRANSDERMAL	34 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	FILM / TRANSDERMAL	11.42 mg		Exact identifier — unii candidate 30 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
MINERAL OIL	MINERAL OIL	T5L8T28FGP	OINTMENT / TOPICAL		9938 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CAPSULE, EXTENDED RELEASE / ORAL	0.07 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CREAM / TOPICAL		2772 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / OPHTHALMIC	88.4 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SUSPENSION / TOPICAL	82 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	TABLET, EXTENDED RELEASE / ORAL	0.18 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / TOPICAL		7275 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	DROPS / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET, FILM COATED / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT, AUGMENTED / TOPICAL	81.94 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	TABLET / ORAL	3.5 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LIQUID / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 18 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	SYSTEM / TRANSDERMAL	6.09 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SYSTEM / TOPICAL	654.36 mg		Exact identifier — unii candidate 30 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
A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A064064-001	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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064064-001	NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC	400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	RS	1995-10-30	`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	A064064-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A064064-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064064-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064064-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064064-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064064-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064064-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064064-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064064-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064064-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064064-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064064-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064064-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064064-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064064-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064064-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064064-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064064-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064064-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064064-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064064-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064064-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064064-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064064-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064064-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064064-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064064-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064064-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064064-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064064-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064064-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064064-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064064-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064064-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064064-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064064-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064064-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064064-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064064-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064064-001	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
f7504b22-2d9e-4e2c-a308-1469bd5a1bab			f7504b22-2d9e-4e2c-a308-1469bd5a1bab	2010-11-04	Warnings, Adverse reactions	Exact identifier spl id: f7504b22-2d9e-4e2c-a308-1469bd5a1bab spl set id: f7504b22-2d9e-4e2c-a308-1469bd5a1bab

Reported adverse events (FAERS/openFDA)#

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