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.
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. DO NOT USE IF IMPRINTED "Protective Seal" WITH YELLOW IS NOT INTACT.
Store between 15°– 30° C (59°– 86° F). PROTECT FROM LIGHT. KEEP OUT OF REACH OF CHILDREN. STERILE OPHTHALMIC SOLUTION Rx Only
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 ADDED: 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 Bl 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:
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:
A wide range of antibacterial action is provided by the overlapping spectra of neomycin, polymyxin B sulfate, and gramicidin.
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.
Gramicidin is bactericidal for a variety of gram-positive organisms. It increases the permeability of the bacterial cell membrane to inorganic cations by forming a network of channels through the normal lipid bilayer of the membrane.
Microbiology: Neomycin sulfate, polymyxin B sulfate and gramicidin 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.
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.
This product is contraindicated in those persons who have shown hypersensitivity to any of its components.
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, General)
As with other antibiotic preparations, prolonged use of this product may result in overgrowth of nonsusceptible organisms including fungi. If superinfection occurs, appropriate measures should be initiated.
Bacterial resistance to this product 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.
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 other 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.
Long-term studies in animals to evaluate carcinogenic or mutagenic potential have not been conducted with polymyxin B sulfate or gramicidin. Treatment of cultured 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.
Pregnancy Category C. Adequate animal reproductive studies have not been conducted with neomycin, polymyxin B or gramicidin. It is also not known whether this product can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This product should be given to a pregnant woman only if clearly needed.
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 this product is administered to a nursing woman.
Safety and effectiveness in pediatric patients have not been established.
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.
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.
DO NOT USE IF IMPRINTED "Protective Seal" WITH YELLOW IS NOT INTACT.
Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution USP NDC 21695-528-10 is supplied in a plastic squeeze bottle with a controlled drop tip in the following size:
10 mL .
Store between 15°– 30° C (59°– 86° F).
PROTECT FROM LIGHT.
KEEP OUT OF REACH OF CHILDREN.
STERILE OPHTHALMIC SOLUTION
Rx Only
Bausch & Lomb Incorporated
Tampa, FL 33637
©Bausch & Lomb Incorporated
Repackaged by:
Rebel Distributors Corp
Thousand Oaks, CA 91320
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 310594 | gramicidin 0.025 MG / neomycin sulfate 1.75 MG / polymyxin B sulfate 10,000 UNT per ML Ophthalmic Solution | PSN | 1 |
| 310594 | gramicidin 0.025 MG/ML / neomycin 1.75 MG/ML / polymyxin B 10000 UNT/ML Ophthalmic Solution | SCD | 1 |
| 310594 | gramicidin 0.025 MG / neomycin (as neomycin sulfate) 1.75 MG / polymyxin B (as polymyxin B sulfate) 10,000 UNT per ML Ophthalmic Solution | SY | 1 |
| Class | Version | Type | Effective |
|---|---|---|---|
| NEOMYCIN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| POLYMYXIN B Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 99e684e6-f435-feb8-d2bb-3a546f1cb768 | Product name | 2 | 20161117 |
| 25340b3b-3e4c-4ff8-abf6-3e62ec46bd0c | Product name | 1 | 20160603 |
| b045ad64-0f28-9a02-2f9b-b34d94fb2278 | Product name | 1 | 20140508 |
| b6082387-f592-1148-0844-bd068fd213fb | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21695-528-10 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4719-48b1-e053-8cdaa90a720a | Neomycin and Polymyxin B Sulfates and Gramicidin Ophthalmic Solution USP |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-528-10 | Neomycin and Polymyxin B Sulfates and Gramicidin | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 1 | |
| 21695-528-10 | Neomycin and Polymyxin B Sulfates and Gramicidin | 10 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 10 | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 21695-528 | NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] | 1 | Legacy NDC, 2 package rows | 20110113_65edc059-0806-4625-b583-0e36f04cf085.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-528-10 | ML - Milliliter | 21695-528 | aee17fa7-f37f-4cad-abda-ad28113e6d25 | 1 | 2012-07-24 |
| 24208-790-62 | ML - Milliliter | 24208-790 | 55970b90-d274-4f80-a8df-f14011e05d9d | 1 | 2012-07-24 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Gramicidin | ACTIVE INGREDIENT | 5IE62321P4 | 1 | |
| Neomycin Sulfate | ACTIVE INGREDIENT | 057Y626693 | 1 | |
| Polymyxin B Sulfate | ACTIVE INGREDIENT | 19371312D4 | 1 | |
| Gramicidin | ACTIVE MOIETY | 5IE62321P4 | 1 | |
| Neomycin | ACTIVE MOIETY | I16QD7X297 | 1 | |
| Polymyxin B | ACTIVE MOIETY | J2VZ07J96K | 1 | |
| Alcohol | INACTIVE INGREDIENT | 3K9958V90M | 1 | |
| AMMONIA | INACTIVE INGREDIENT | 5138Q19F1X | 1 | |
| Hydrochloric Acid | INACTIVE INGREDIENT | QTT17582CB | 1 | |
| POLOXAMER 188 | INACTIVE INGREDIENT | LQA7B6G8JG | 1 | |
| POLYETHYLENE GLYCOL | INACTIVE INGREDIENT | 3WJQ0SDW1A | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| Sodium Chloride | INACTIVE INGREDIENT | 451W47IQ8X | 1 | |
| Thimerosal | INACTIVE INGREDIENT | 2225PI3MOV | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 21695-528 | 21695-528-10 |
| 24208-790 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Neomycin Sulfate | 057Y626693 | ACTIB |
| Polymyxin B Sulfate | 19371312D4 | ACTIB |
| Gramicidin | 5IE62321P4 | ACTIB |
| Alcohol | 3K9958V90M | IACT |
| AMMONIA | 5138Q19F1X | IACT |
| POLYETHYLENE GLYCOL | 3WJQ0SDW1A | IACT |
| Hydrochloric Acid | QTT17582CB | IACT |
| POLOXAMER 188 | LQA7B6G8JG | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| Water | 059QF0KO0R | IACT |
| Sodium Chloride | 451W47IQ8X | IACT |
| Thimerosal | 2225PI3MOV | IACT |
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / OPHTHALMIC | 0.5 %w/v | ||
| Hydrochloric Acid | HYDROCHLORIC ACID | QTT17582CB | SOLUTION/ DROPS / OPHTHALMIC | ADJ PH | ||
| AMMONIA | AMMONIA SOLUTION | 5138Q19F1X | SOLUTION / OPHTHALMIC | ADJ PH | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION/ DROPS / OPHTHALMIC | 55 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION/ DROPS / OPHTHALMIC | 0.75 %w/v | ||
| Thimerosal | THIMEROSAL | 2225PI3MOV | SOLUTION/ DROPS / OPHTHALMIC | NA | ||
| POLOXAMER 188 | POLOXAMER 188 | LQA7B6G8JG | SOLUTION / OPHTHALMIC | 0.1 %w/v |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A064047-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1996-01-31 |
| Application-product | TE code |
|---|---|
| A064047-001 | AT |
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.
| 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 | A064047-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1996-01-31 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A064047-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1996-01-31 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A064047-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1996-01-31 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A064047-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1996-01-31 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A064047-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1996-01-31 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A064047-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1996-01-31 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A064047-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1996-01-31 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A064047-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1996-01-31 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A064047-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1996-01-31 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A064047-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1996-01-31 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A064047-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1996-01-31 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A064047-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1996-01-31 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A064047-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1996-01-31 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A064047-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1996-01-31 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A064047-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1996-01-31 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A064047-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1996-01-31 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A064047-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1996-01-31 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A064047-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1996-01-31 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A064047-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1996-01-31 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A064047-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1996-01-31 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A064047-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1996-01-31 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A064047-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1996-01-31 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A064047-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1996-01-31 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A064047-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1996-01-31 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A064047-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1996-01-31 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A064047-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1996-01-31 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A064047-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1996-01-31 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A064047-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1996-01-31 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A064047-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1996-01-31 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A064047-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1996-01-31 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A064047-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1996-01-31 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A064047-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1996-01-31 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A064047-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1996-01-31 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A064047-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1996-01-31 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A064047-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1996-01-31 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A064047-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1996-01-31 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A064047-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1996-01-31 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A064047-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1996-01-31 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A064047-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1996-01-31 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A064047-001 | NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 UNITS/ML | SOLUTION/DROPS / OPHTHALMIC | AT | RS | 1996-01-31 | f41ea6bd6efb… |
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A064047-001 | AT | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A064047-001 | AT | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A064047-001 | AT | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A064047-001 | AT | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A064047-001 | AT | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A064047-001 | AT | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A064047-001 | AT | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A064047-001 | AT | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A064047-001 | AT | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A064047-001 | AT | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A064047-001 | AT | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A064047-001 | AT | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A064047-001 | AT | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A064047-001 | AT | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A064047-001 | AT | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A064047-001 | AT | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A064047-001 | AT | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A064047-001 | AT | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A064047-001 | AT | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A064047-001 | AT | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A064047-001 | AT | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A064047-001 | AT | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A064047-001 | AT | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A064047-001 | AT | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A064047-001 | AT | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A064047-001 | AT | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A064047-001 | AT | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A064047-001 | AT | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A064047-001 | AT | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A064047-001 | AT | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A064047-001 | AT | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A064047-001 | AT | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A064047-001 | AT | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A064047-001 | AT | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A064047-001 | AT | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A064047-001 | AT | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A064047-001 | AT | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A064047-001 | AT | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A064047-001 | AT | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A064047-001 | AT | 1 | f41ea6bd6efb… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN | NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND GRAMICIDIN | Bausch & Lomb Incorporated | e6f8d2f6-adff-4ae1-982c-45562f0a8e28 | 2024-09-18 | Warnings, Adverse reactions | 24208-790 |
| 65edc059-0806-4625-b583-0e36f04cf085 | 65edc059-0806-4625-b583-0e36f04cf085 | 2011-01-03 | Warnings, Adverse reactions | 65edc059-0806-4625-b583-0e36f04cf085 65edc059-0806-4625-b583-0e36f04cf085 |
Adverse event summaries are temporarily unavailable. Other product information remains available.