Erythromycin Ophthalmic Ointment USP, 0.5% Sterile

Manufacturer: Akorn, Inc. | Akorn Operating Company LLC | Akorn, Inc
Effective date: 2020-10-08
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 6
Source: legacy-cache
Hydrated at: 2026-08-01 23:12:17

Label at a glance#

ProductErythromycin

Active ingredientErythromycin

Label structure11 sections

Indications and uses

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.gonorrhoeae is not established. For infants born to mothers with clinically apparent gonorrh...

Dosage and administration

In the treatment of superficial ocular infections, a ribbon approximately 1 cm in length of Erythromycin Opthalmic 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. Th...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Rx only

DESCRIPTION:

DESCRIPTION SECTION

Erythromycin 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-O-methyl-α-L-ribo-hexopyranosyl)-oxy]-14-ethyl-7,12,13-trihy-droxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethyl-amino)-β-D-xylo-hexopyranosyl]oxy]oxacy-clotetradecane-2,10-dione)) is an 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.

CLINICAL PHARMACOLOGY:

CLINICAL PHARMACOLOGY SECTION

MICROBIOLOGY SECTION

Microbiology: 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 β-hemolytic)
Alpha-hemolytic streptococci (viridans group)
Staphylococcus aureus, including penicillinase-producing strains (methicillin-resistant staphylococci are uniformly resistant to erythromycin)
Streptococcus pneumoniae
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

INDICATIONS AND USAGE:

INDICATIONS & USAGE SECTION

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.gonorrhoeae 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.

CONTRAINDICATIONS:

CONTRAINDICATIONS SECTION

This drug is contraindicated in patients with a history of hypersensitivity to erythromycin.

PRECAUTIONS:

PRECAUTIONS SECTION

GENERAL PRECAUTIONS SECTION

General: 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.

INFORMATION FOR PATIENTS SECTION

Information for Patients: Avoid contaminating the applicator tip with material from the eye, fingers, or other source.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

Carcinogenesis, Mutagenesis, Impairment of Fertility:

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.

PREGNANCY SECTION

Pregnancy: Teratogenic Effects: Pregnancy Category B. 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.

NURSING MOTHERS SECTION

Nursing Mothers: Caution should be exercised when erythromycin is administered to a nursing woman.

PEDIATRIC USE SECTION

Pediatric Use - See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION.

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

The most frequently reported adverse reactions are minor ocular irritations, redness, and hypersensitivity reactions.

DOSAGE AND ADMINISTRATION:

DOSAGE & ADMINISTRATION SECTION

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.

HOW SUPPLIED:

HOW SUPPLIED SECTION

Sterile Erythromycin Ophthalmic Ointment USP, 0.5% is available as follows:

3.5 g (1/8 oz) sterile tamper-resistant tube

(NDC 17478-824-35)

Carton of fifty (50) Unit Dose 1 g tube

(NDC 17478-824-01)

STORAGE AND HANDLING SECTION

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

Avoid excessive heat.

Protect from freezing.

PREMIERProRx^®
Manufactured by: Akorn Inc
Lake Forest, IL 60045

PremierProRx^® is a registered trademark of Premier Inc., used under license.

PERT00N
Rev. 10/15

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC 17478-824-35 Premier Logo

ERYTHROMYCIN OPHTHALMIC

OINTMENT USP, 0.5%

Rx only Sterile

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

Principal Display Panel Text for Container Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

NDC 17478-824-35

ERYTHROMYCIN OPHTHALMIC

OINTMENT USP, 0.5%

Sterile

Net Wt 3.5 g (1/8 oz.)

Rx only Premier Logo

Principal Display Panel Text for Carton Label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17478-824-01	GM - Gram	17478-824	acd0d0f2-c3c6-414f-a70c-62c56060afc9	1	2013-07-02
17478-824-35	GM - Gram	17478-824	0f84c3e1-4a03-491f-9101-41b220fde29d	1	2013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Erythromycin	ACTIVE INGREDIENT	63937KV33D	1
Erythromycin	ACTIVE MOIETY	63937KV33D	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 · 3 matching rows.

Erythromycin
mineral oil
petrolatum

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
17478-824	17478-824-35, 17478-824-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Erythromycin	63937KV33D	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
petrolatum	PETROLATUM	4T6H12BN9U	OINTMENT / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 18 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	TABLET, EXTENDED RELEASE / ORAL	0.18 mg		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	DROPS / ORAL	NA		Exact identifier — unii candidate 30 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	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
petrolatum	PETROLATUM	4T6H12BN9U	CAPSULE, EXTENDED RELEASE / ORAL	0.07 mg		Exact identifier — unii candidate 18 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, FILM COATED / ORAL	NA		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
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	PASTE / TOPICAL	47.5 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
mineral oil	MINERAL OIL	T5L8T28FGP	TABLET / ORAL	113.75 mg		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
petrolatum	PETROLATUM	4T6H12BN9U	OINTMENT / OPHTHALMIC	88.4 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
mineral oil	MINERAL OIL	T5L8T28FGP	PASTE / DENTAL	95 %w/w		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
mineral oil	MINERAL OIL	T5L8T28FGP	SUSPENSION / TOPICAL	82 %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	OINTMENT / OPHTHALMIC	59.5 %w/w		Exact identifier — unii candidate 30 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	SYSTEM / TOPICAL	654.36 mg		Exact identifier — unii candidate 30 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	SYSTEM / TRANSDERMAL	6.09 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
mineral oil	MINERAL OIL	T5L8T28FGP	SUPPOSITORY / RECTAL	NA		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	CREAM / TOPICAL		2772 mg	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	SUSPENSION / AURICULAR (OTIC)	0.5 %w/v		Exact identifier — unii candidate 30 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	CAPSULE / ORAL		120 mg	Exact identifier — unii candidate 30 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	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
mineral oil	MINERAL OIL	T5L8T28FGP	OINTMENT / AURICULAR (OTIC)	NA		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
petrolatum	PETROLATUM	4T6H12BN9U	OINTMENT / VAGINAL		4084 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
mineral oil	MINERAL OIL	T5L8T28FGP	SUPPOSITORY / VAGINAL	30 mg		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	SUPPOSITORY / VAGINAL	27 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
mineral oil	MINERAL OIL	T5L8T28FGP	FILM / TRANSDERMAL	11.42 mg		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	SPRAY / TOPICAL		1379 mg	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	TABLET, CHEWABLE / ORAL		6 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
A064030-001	ERYTHROMYCIN	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT		1996-07-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A064030-001	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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064030-001	ERYTHROMYCIN	0.5%	OINTMENT / OPHTHALMIC	AT	1996-07-18	`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	A064030-001	AT	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A064030-001	AT	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064030-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064030-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064030-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064030-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064030-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064030-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064030-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064030-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064030-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064030-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064030-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064030-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064030-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064030-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064030-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064030-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064030-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064030-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064030-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064030-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064030-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064030-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064030-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064030-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064030-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064030-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064030-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064030-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064030-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064030-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064030-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064030-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064030-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064030-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064030-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064030-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064030-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064030-001	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
a291e5e0-ecf8-4d8e-b093-0adf32b467a6			f4b57b8a-089e-4bbc-bcc7-3a9b9b600930	2020-10-08	Adverse reactions	Exact identifier spl set id: f4b57b8a-089e-4bbc-bcc7-3a9b9b600930

Reported adverse events (FAERS/openFDA)#

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