Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment USP, Sterile

Manufacturer: Akorn | Akorn Operating Company LLC
Effective date: 2020-10-08
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-05-31 20:39:25

Label at a glance#

ProductAK-POLY-BAC

Active ingredientBacitracin Zinc, Polymyxin B Sulfate

Label structure12 sections

Indications and uses

For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to bacitracin zinc and polymyxin B sulfate.

Dosage and administration

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

Storage and handling

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Akorn Manufactured By: Akorn, Inc. Lake Forest, IL 60045 AKP00N Rev. 06/16

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Rx only

DESCRIPTION:

DESCRIPTION SECTION

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

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 for bacitracin A is:

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:

Each gram contains: Bacitracin zinc equal to 500 bacitracin units and polymyxin B sulfate equal to 10,000 polymyxin B units, white petrolatum and mineral oil.

CLINICAL PHARMACOLOGY:

CLINICAL PHARMACOLOGY SECTION

Polymyxin B attacks gram-negative bacilli, including virtually all strains of Pseudomonas aeruginosa and H influenzae species.

Bacitracin is active against most gram-positive bacilli and cocci including hemolytic streptococci.

INDICATIONS AND USAGE:

INDICATIONS & USAGE SECTION

For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to bacitracin zinc and polymyxin B sulfate.

CONTRAINDICATIONS:

CONTRAINDICATIONS SECTION

This product is contraindicated in those individuals who have shown hypersensitivity to any of its components.

WARNINGS:

WARNINGS SECTION

Ophthalmic ointments may retard corneal healing.

PRECAUTIONS:

PRECAUTIONS SECTION

As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. Appropriate measures should be taken if this occurs.

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

Bacitracin Zinc and Polymyxin B Sulfate ophthalmic ointment USP, sterile, each gram contains bacitracin zinc equal to 500 bacitracin units and polymyxin B sulfate equal to 10,000 polymyxin B units, in a tube of 3.5 g (1/8 oz) with ophthalmic tip.

NDC 17478-238-35

STORAGE:

STORAGE AND HANDLING SECTION

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

Akorn
Manufactured By: Akorn, Inc.
Lake Forest, IL 60045
AKP00N
Rev. 06/16

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Container Label:

NDC 17478-238-35 Akorn

AK-POLY-BAC™

brand of Bacitracin Zinc and Polymyxin B Sulfate

Ophthalmic Ointment USP

For Ophthalmic Use Only. Sterile

Rx only 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 17478-238-35

AK-POLY-BAC™

brand of Bacitracin Zinc and Polymyxin B Sulfate

Ophthalmic Ointment, USP

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

Principal Display Panel Text for Carton Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
308511	bacitracin zinc 500 UNT / polymyxin B sulfate 10,000 UNT per GM Ophthalmic Ointment	PSN	6
308511	bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Ophthalmic Ointment	SCD	6
308511	bacitracin (as bacitracin zinc) 500 UNT / polymyxin B (as polymyxin B sulfate) 10,000 UNT per GM Ophthalmic Ointment	SY	6

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0c	Product name	1	20160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4	Product name	1	20150819
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
17478-238-35	2024-01-30	C162847	48780-1	1030e365-3bb7-111a-e063-dadaa90a10e2	Bacitracin Zinc and Polymyxin B Sulfate Ophthalmic Ointment USP, Sterile

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
17478-238-35	AK-POLY-BAC	3.5 g in 1 TUBE	OINTMENT	3.5		6
17478-238-35	AK-POLY-BAC	1 in 1 CARTON	OINTMENT	1		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17478-238	AK-POLY-BAC (BACITRACIN ZINC AND POLYMYXIN B SULFATE) OINTMENT [AKORN]	6	Legacy NDC, 2 package rows	20220121_8b750666-18f2-40f5-9fb3-87457001b485.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17478-238-35	GM - Gram	17478-238	18c4098a-02ad-4932-823e-5e791bce449d	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Bacitracin Zinc	ACTIVE INGREDIENT	89Y4M234ES	2
Polymyxin B Sulfate	ACTIVE INGREDIENT	19371312D4	2
Bacitracin	ACTIVE MOIETY	58H6RWO52I	2
Polymyxin B	ACTIVE MOIETY	J2VZ07J96K	2
Mineral Oil	INACTIVE INGREDIENT	T5L8T28FGP	2
Petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	2

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

AK-POLY-BAC
Bacitracin Zinc and Polymyxin B Sulfate
Bacitracin Zinc
Bacitracin
Polymyxin B Sulfate
Polymyxin B
Mineral Oil
Petrolatum

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
17478-238	17478-238-35

Ingredients#

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

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

Name, UNII, Kind table
Name	UNII	Kind
Bacitracin Zinc	89Y4M234ES	ACTIM
Polymyxin B Sulfate	19371312D4	ACTIM
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	CAPSULE, EXTENDED RELEASE / ORAL	0.07 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	TABLET, EXTENDED RELEASE / ORAL	NA		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
Mineral Oil	MINERAL OIL	T5L8T28FGP	TABLET, CHEWABLE / ORAL		6 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	TABLET, FILM COATED / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	CREAM / VAGINAL		402 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	TABLET, EXTENDED RELEASE / ORAL	0.18 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	OINTMENT / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	CAPSULE / VAGINAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	SUSPENSION / TOPICAL	82 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	CREAM, AUGMENTED / TOPICAL	26 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	CAPSULE / ORAL		120 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	FILM / TRANSDERMAL	11.42 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	CREAM / TOPICAL		2772 mg	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	SOAP / TOPICAL	0.82 %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
Petrolatum	PETROLATUM	4T6H12BN9U	EMULSION / TOPICAL	7.8 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	OINTMENT / TOPICAL		7275 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	OINTMENT / OPHTHALMIC	59.5 %w/w		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
Mineral Oil	MINERAL OIL	T5L8T28FGP	GEL / TOPICAL	2.5 %w/w		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	TABLET, DELAYED RELEASE / ORAL	5.67 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	SUPPOSITORY / VAGINAL	30 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	CAPSULE, EXTENDED RELEASE / ORAL		120 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	TABLET / ORAL	3.5 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	SPONGE / TOPICAL	NA		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	TABLET / ORAL	113.75 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	PASTE / DENTAL	95 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	SOAP / TOPICAL	0.85 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	AEROSOL, FOAM / TOPICAL	7.9 %w/w		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
Mineral Oil	MINERAL OIL	T5L8T28FGP	SPRAY / TOPICAL		1379 mg	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	OINTMENT / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
Mineral Oil	MINERAL OIL	T5L8T28FGP	TABLET, COATED / ORAL	1.5 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
Petrolatum	PETROLATUM	4T6H12BN9U	SUPPOSITORY / VAGINAL	27 mg		Exact identifier — unii candidate 18 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	LOTION / TOPICAL	25 %w/w		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
Petrolatum	PETROLATUM	4T6H12BN9U	LIQUID / RESPIRATORY (INHALATION)	NA		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	PASTE / TOPICAL	47.5 %w/w		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
A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	BACITRACIN ZINC; POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC			1995-01-30

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	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		1995-01-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		1995-01-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		1995-01-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		1995-01-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		1995-01-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		1995-01-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		1995-01-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		1995-01-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		1995-01-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		1995-01-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		1995-01-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		1995-01-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		1995-01-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC		1995-01-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064028-001	BACITRACIN ZINC AND POLYMYXIN B SULFATE	500 UNITS/GM;10,000 UNITS/GM	OINTMENT / OPHTHALMIC	AT	1995-01-30	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A064028-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A064028-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A064028-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A064028-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A064028-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A064028-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A064028-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A064028-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A064028-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A064028-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A064028-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A064028-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A064028-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A064028-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A064028-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A064028-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A064028-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A064028-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A064028-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A064028-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A064028-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A064028-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A064028-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A064028-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A064028-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A064028-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A064028-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A064028-001	AT	1	`cb3db0bc1861…`

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
f764e0be-a828-4f44-9c91-86326a152f48			8b750666-18f2-40f5-9fb3-87457001b485	2020-10-08	Warnings	Exact identifier spl id: f764e0be-a828-4f44-9c91-86326a152f48 spl set id: 8b750666-18f2-40f5-9fb3-87457001b485

Reported adverse events (FAERS/openFDA)#

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