Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment, USP

Manufacturer
Henry Schein Inc. | Akorn Operating Company LLC
Effective date
2022-02-02
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:09:42

Label at a glance#

ProductNeomycin and Polymyxin B Sulfates, and Bacitracin Zinc
Active ingredientNeomycin Sulfate, Polymyxin B Sulfate, Bacitracin Zinc
Label structure12 sections

Indications and uses

Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment. USP 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: Neomycin Sulfate (equivalent to 3.5 mg neomycin base), Polymyxin B sulfate equal to 10,000 polymyxin B units, bacitracin zinc equal to 400 bacitracin units, and white petrolatum, q.s.

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 mcg of neomycin standard per mg, calculated on an anhydrous basis. The structural formula are:

Neomycin Sulfate Structural Formula
Neomycin Sulfate Structural Formula

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 mg, calculated on an anhydrous basis. The structural formulae are:

Polymyxin B Sulfate Structural Formula
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 mg. The structural formula is:

Bacitracin Zinc Structural Formula
Bacitracin Zinc Structural Formula

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 SECTION

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

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment. USP 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.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment, USP is contraindicated in 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 Ointment, USP 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 PRECAUTIONS SECTION

General: As with other antibiotic preparations, prolonged use of Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ophthalmic Ointment, USP 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, USP 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 SECTION

Information for Patients: 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 SECTION

Carcinogenesis, Mutagenesis, Impairment of Fertility: 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, liter size or survival were observed in rabbits given bacitracin zinc 100 gm/ton of diet.

PREGNANCY SECTION

Pregnancy: Teratogenic Effects: 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, USP 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, USP should be given to pregnant woman only if clearly needed.

NURSING MOTHERS SECTION

Nursing Mothers: 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, USP is administered to a nursing woman.

PEDIATRIC USE SECTION

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

GERIATRIC USE SECTION

Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

Adverse reactions have occurred with the anti-infective components of Neomycin and Polymyxin B Sulfate and Bacitracin Zinc Ophthalmic Ointment, USP. 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

Tube of 1/8 oz. (3.5 g) with ophthalmic tip.

NDC 0404-7194-01

STORAGE AND HANDLING SECTION

Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Distributed by (in US only):
HENRY SCHEIN INC.
135 DURYEA ROAD
MELVILLE, NY 11747 USA

BNPB00N Rev. 10/15

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

HENRY SCHEIN Logo

NDC 0404-7194-01

112-7194

NEOMYCIN AND POLYMYXIN B SULFATES AND

BACITRACIN ZINC OPHTHALMIC OINTMENT, USP

Sterile Ophthalmic Ointment

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

Principal Display Panel Text for Container Label
Principal Display Panel Text for Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

HENRY SCHEIN Logo

NDC 0404-7194-01

112-7194

NEOMYCIN AND POLYMYXIN B SULFATES AND

BACITRACIN ZINC OPHTHALMIC OINTMENT, USP

Sterile Ophthalmic Ointment Rx only Net Wt. 3.5 g (1/8 oz.)

Principal Display Panel Text for Carton Label
Principal Display Panel Text for Carton Label

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Bacitracin ZincACTIVE INGREDIENT89Y4M234ES1
Neomycin SulfateACTIVE INGREDIENT057Y6266931
Polymyxin B SulfateACTIVE INGREDIENT19371312D41
BacitracinACTIVE MOIETY58H6RWO52I1
NeomycinACTIVE MOIETYI16QD7X2971
Polymyxin BACTIVE MOIETYJ2VZ07J96K1
PetrolatumINACTIVE INGREDIENT4T6H12BN9U1

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0404-71940404-7194-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

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 · 18 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PetrolatumPETROLATUM4T6H12BN9UOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UOINTMENT, AUGMENTED / TOPICAL81.94 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UOINTMENT / VAGINAL4084 mgExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9ULOTION / TOPICAL25 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UTABLET / ORAL3.5 mgExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UCAPSULE, EXTENDED RELEASE / ORAL0.07 mgExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UEMULSION / TOPICAL7.8 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UCREAM, AUGMENTED / TOPICAL26 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UTABLET, EXTENDED RELEASE / ORAL0.18 mgExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UAEROSOL, FOAM / TOPICAL7.9 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UOINTMENT / OPHTHALMIC88.4 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9USPONGE / TOPICALNAExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9USUPPOSITORY / VAGINAL27 mgExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9USOAP / TOPICAL0.85 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9ULIQUID / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
18 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UCAPSULE / VAGINALNAExact 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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065088-001NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINCBACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMIC2004-02-06

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A065088-001NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMIC2004-02-0684e616aacf4f…
2026-08-18 06:07:402026-07A065088-001NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMIC2004-02-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A065088-001NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMIC2004-02-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A065088-001NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMIC2004-02-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A065088-001NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMIC2004-02-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A065088-001NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMIC2004-02-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A065088-001NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMIC2004-02-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A065088-001NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMIC2004-02-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A065088-001NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMIC2004-02-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A065088-001NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMIC2004-02-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A065088-001NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMIC2004-02-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A065088-001NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMIC2004-02-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A065088-001NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMIC2004-02-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A065088-001NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMIC2004-02-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A065088-001NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMIC2004-02-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A065088-001NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMIC2004-02-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065088-001NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2004-02-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065088-001NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2004-02-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065088-001NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2004-02-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065088-001NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2004-02-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065088-001NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2004-02-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065088-001NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2004-02-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065088-001NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2004-02-0687673890dc5c…
2021-03-12 10:30 UTC2021-03A065088-001NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2004-02-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065088-001NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2004-02-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065088-001NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2004-02-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065088-001NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2004-02-063f01610625f2…
2019-09-15 20:21 UTC2019-09A065088-001NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2004-02-06b00525d2431f…
2019-07-19 19:46 UTC2019-07A065088-001NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2004-02-06ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A065088-001NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMIC2004-02-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A065088-001NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMIC2004-02-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12A065088-001NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMIC2004-02-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A065088-001NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMIC2004-02-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A065088-001NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMIC2004-02-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A065088-001NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMIC2004-02-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A065088-001NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMIC2004-02-063f0d92c62455…
2023-05-13 08:27 UTC2023-05A065088-001NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMIC2004-02-06053a50430f4f…
2023-01-26 05:58 UTC2023-01A065088-001NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2004-02-063bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065088-001NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2004-02-063a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065088-001NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GMOINTMENT / OPHTHALMICAT2004-02-06f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A065088-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A065088-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A065088-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A065088-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A065088-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A065088-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A065088-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A065088-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A065088-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A065088-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A065088-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A065088-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A065088-001AT1ea99ee380514…
2023-01-26 05:58 UTC2023-01A065088-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A065088-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A065088-001AT1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065088-001AT1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065088-001AT1cb3db0bc1861…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
906e3835-5764-4340-ade0-1176b086ae8102af2a5f-32fb-460b-b29f-7b18cb95204c2023-11-27Warnings, Adverse reactionsExact identifier
spl set id: 02af2a5f-32fb-460b-b29f-7b18cb95204c

Reported adverse events (FAERS/openFDA)#

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