For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to erythromycin. For prophylaxis of ophthalmia neonatorum due to N. gonorrhoeae or C. trachomatis . The effectiveness of erythromycin in the prevention of ophthalmia caused by penicillinase-producing N. gonorrheae is not established. For infants born to mothers with clinically apparent gonorrh...
In the treatment of superficial ocular infections, a ribbon approximately 1 cm in length of Erythromycin Ophthalmic Ointment should be applied directly to the infected structure up to 6 times daily, depending on the severity of the infection. For prophylaxis of neonatal gonococcal or chlamydial conjunctivitis, a ribbon of ointment approximately 1 cm in length should be instilled into each lower conjunctival sac. T...
www.fda.gov/medwatchErythromycin Ophthalmic Ointment belongs to the macrolide group of antibiotics. It is basic and readily forms a salt when combined with an acid. The base, as crystals or powder, is slightly soluble in water, moderately soluble in ether, and readily soluble in alcohol or chloroform. Erythromycin ((3R*,4S*,5S*,6R*,7R*,9R*,11R*,12R*,13S*,14R*)-4-[(2,6-dideoxy-3-C-methyl-3-0-methyl-α-L-ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-ß-D-xylo-hexopyranosyl]oxy]oxacyclotetradecane-2,10-dione) is antibiotic produced from a strain of Streptomyces erythraeus. It has the following structural formula:
Each gram contains Erythromycin USP 5 mg in a sterile ophthalmic base of mineral oil and white petrolatum.
Erythromycin inhibits protein synthesis without affecting nucleic acid synthesis. Erythromycin is usually active against the following organisms in vitro and in clinical infections:
Streptococcus pyogenes (group A ß-hemolytic)
Alpha-hemolytic streptococci (viridans group)
Staphylococcus aureus, including penicillinase-producing strains (methicillin-resistant staphylococci are uniformly resistant to erythromycin)
Streptococcus pneumonia
Mycoplasma pneumoniae (Eaton Agent, PPLO)
Haemophilus influenzae (not all strains of this organism are susceptible at the erythromycin concentrations ordinarily achieved)
Treponema pallidum
Corynebacterium diphtheriae
Neisseria gonorrhoeae
Chlamydia trachomatis
For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to erythromycin.
For prophylaxis of ophthalmia neonatorum due to N. gonorrhoeae or C. trachomatis. The effectiveness of erythromycin in the prevention of ophthalmia caused by penicillinase-producing N. gonorrheae is not established.
For infants born to mothers with clinically apparent gonorrhea, intravenous or intramuscular injections of aqueous crystalline penicillin G should be given; a single dose of 50,000 units for term infants or 20,000 units for infants of low birth weight. Topical prophylaxis alone is inadequate for these infants.
This drug is contraindicated in patients with a history of hypersensitivity to erythromycin.
The use of antimicrobial agents may be associated with the overgrowth of nonsusceptible organisms including fungi; in such a case, antibiotic administration should be stopped and appropriate measures taken.
Avoid contaminating the applicator tip with material from the eye, fingers, or other source.
Two year oral studies conducted in rats with erythromycin did not provide evidence of tumorigenicity. Mutagenicity studies have not been conducted.
No evidence of impaired fertility that appeared related to erythromycin was reported in animal studies.
Reproduction studies have been performed in rats, mice, and rabbits using erythromycin and its various salts and esters, at doses that were several multiples of the usual human dose. No evidence of harm to the fetus that appeared related to erythromycin was reported in these studies. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, the erythromycins should be used during pregnancy only if clearly needed.
Caution should be exercised when erythromycin is administered to a nursing woman.
See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION.
The most frequently reported adverse reactions are minor ocular irritations, redness, and hypersensitivity reactions.
To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
In the treatment of superficial ocular infections, a ribbon approximately 1 cm in length of Erythromycin Ophthalmic Ointment should be applied directly to the infected structure up to 6 times daily, depending on the severity of the infection. For prophylaxis of neonatal gonococcal or chlamydial conjunctivitis, a ribbon of ointment approximately 1 cm in length should be instilled into each lower conjunctival sac. The ointment should not be flushed from the eye following instillation. A new tube should be used for each infant.
Product: 50090-1958
NDC: 50090-1958-0 3.5 g in a TUBE / 1 in a CARTON
Manufactured For
Perrigo®
Minneapolis, MN 55427
SW700 RC J1 Rev 09-13 A
R1013
Ini 0813
| Class | Version | Type | Effective |
|---|---|---|---|
| ERYTHROMYCIN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d329c2e1-5ae8-4e64-aea0-77ecea3fa1ab | Product name | 3 | 20250717 |
| 3b331500-3b74-bd2b-fede-d46839f2f4d5 | Product name | 6 | 20240313 |
| fdae2630-eae0-4769-abfd-8f33d5b771b4 | Product name | 3 | 20240202 |
| 8c898317-b543-1e4e-254f-84cec2f3f57e | Product name | 2 | 20191002 |
| 64ae94c0-3212-d73a-92da-9e6dd85c6ebe | Product name | 2 | 20180118 |
| edcfa1cf-915f-1a4c-d0aa-508cc66e70d9 | Product name | 2 | 20170816 |
| ad75fcfd-a339-42a1-9c60-43ba2c654cfa | Product name | 1 | 20170810 |
| 57850177-5927-151f-e1fa-7e2ca47f81e5 | Product name | 1 | 20140508 |
| 8ee71591-1d8f-e24e-242b-bfef131e3168 | Product name | 1 | 20140508 |
| bff5cf99-0f45-fa15-2a76-b160c3c4cc3c | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50090-1958-0 | 2023-02-07 | C162847 | 48780-1 | f386c649-a88f-0266-e053-dadaa90a7c1a | ERYTHROMYCIN OPHTHALMIC OINTMENT USP STERILE RX ONLY |
| 50090-1958-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-a88f-0266-e053-dadaa90a7c1a | ERYTHROMYCIN OPHTHALMIC OINTMENT USP STERILE RX ONLY |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50090-1958-0 | erythromycin | 1 in 1 CARTON | OINTMENT | 1 | 15 | |
| 50090-1958-0 | erythromycin | 3.5 g in 1 TUBE | OINTMENT | 3.5 | 15 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50090-1958 | ERYTHROMYCIN OINTMENT [A-S MEDICATION SOLUTIONS] | 15 | Current NDC, Legacy NDC, 2 package rows | 20230208_1df12239-6957-4b2c-9e65-e2154eafddd0.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50090-1958-0 | GM - Gram | 50090-1958 | 0acfe329-1ad8-45b3-b486-b2e46a37f90d | 1 | 2018-11-06 |
| 0574-4024-35 | GM - Gram | 0574-4024 | 9a87c916-2490-4c08-8964-471e41c5f451 | 1 | 2014-07-02 |
| 0574-4024-39 | GM - Gram | 0574-4024 | 4cb5a47a-89ff-45e7-8c36-36df8f52f675 | 1 | 2014-11-05 |
| 0574-4024-50 | GM - Gram | 0574-4024 | 0c233232-0d3a-433e-b69a-ab381af03e9e | 1 | 2014-07-02 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 50090-1958 | 50090-1958-0 |
| 0574-4024 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ERYTHROMYCIN | 63937KV33D | ACTIB |
| PETROLATUM | 4T6H12BN9U | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
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 |
|---|---|---|---|---|---|---|---|
| A062447-001 | ERYTHROMYCIN | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | 1983-09-26 |
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 | A062447-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | 1983-09-26 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062447-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | 1983-09-26 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062447-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | 1983-09-26 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062447-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | 1983-09-26 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A062447-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | 1983-09-26 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062447-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | 1983-09-26 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062447-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | 1983-09-26 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062447-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | 1983-09-26 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062447-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | 1983-09-26 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062447-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | 1983-09-26 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062447-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | 1983-09-26 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A062447-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | 1983-09-26 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062447-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | 1983-09-26 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062447-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | 1983-09-26 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A062447-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | 1983-09-26 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A062447-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | 1983-09-26 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A062447-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | RS | 1983-09-26 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A062447-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | RS | 1983-09-26 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A062447-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | RS | 1983-09-26 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A062447-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | RS | 1983-09-26 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A062447-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | RS | 1983-09-26 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A062447-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | RS | 1983-09-26 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A062447-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | RS | 1983-09-26 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A062447-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | RS | 1983-09-26 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A062447-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | RS | 1983-09-26 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A062447-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | RS | 1983-09-26 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A062447-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | RS | 1983-09-26 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A062447-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | RS | 1983-09-26 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A062447-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | RS | 1983-09-26 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A062447-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | RS | 1983-09-26 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A062447-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | RS | 1983-09-26 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A062447-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | RS | 1983-09-26 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A062447-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | RS | 1983-09-26 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A062447-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | RS | 1983-09-26 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A062447-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | RS | 1983-09-26 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A062447-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | RS | 1983-09-26 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A062447-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | RS | 1983-09-26 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A062447-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | RS | 1983-09-26 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A062447-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | RS | 1983-09-26 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A062447-001 | ERYTHROMYCIN | 0.5% | OINTMENT / OPHTHALMIC | AT | RS | 1983-09-26 | f41ea6bd6efb… |
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A062447-001 | AT | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A062447-001 | AT | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A062447-001 | AT | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A062447-001 | AT | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A062447-001 | AT | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A062447-001 | AT | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A062447-001 | AT | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A062447-001 | AT | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A062447-001 | AT | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A062447-001 | AT | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A062447-001 | AT | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A062447-001 | AT | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A062447-001 | AT | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A062447-001 | AT | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A062447-001 | AT | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A062447-001 | AT | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A062447-001 | AT | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A062447-001 | AT | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A062447-001 | AT | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A062447-001 | AT | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A062447-001 | AT | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A062447-001 | AT | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A062447-001 | AT | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A062447-001 | AT | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A062447-001 | AT | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A062447-001 | AT | 1 | cb3db0bc1861… |
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 |
|---|---|---|---|---|---|---|
| erythromycin | ERYTHROMYCIN | A-S Medication Solutions | 1df12239-6957-4b2c-9e65-e2154eafddd0 | 2023-02-04 | Adverse reactions | 50090-1958-0 50090-1958 50090195800 c1d481ba-af9a-43d1-80ed-9db6109fe3ad 1df12239-6957-4b2c-9e65-e2154eafddd0 |
Adverse event summaries are temporarily unavailable. Other product information remains available.