Double Antibiotic

Product NDC: 58980-012
11-digit product format: 589800012
Labeler code: 58980
Product ID: 58980-012_6c82f396-e1f6-4210-87b1-2615eedbdc6a
Type: HUMAN OTC DRUG
Nonproprietary name: BACITRACIN ZINC and POLYMYXIN B SULFATE
Dosage form: OINTMENT
Route: TOPICAL
Labeler: STRATUS PHARMACEUTICALS INC
Application: M004
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2017-09-15
Substance: BACITRACIN ZINC; POLYMYXIN B SULFATE
Active strength: 500; 10000 [USP'U]/g; [USP'U]/g
Pharmacologic classes: Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Double Antibiotic
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BACITRACIN ZINC	500 [USP'U]/g
POLYMYXIN B SULFATE	10000 [USP'U]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
89Y4M234ES	Internal UNII lookup
19371312D4	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
308512	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f64b3564-ea3c-4316-8f00-f92c08dcad35	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
58980-012-01	Double Antibiotic	144 in 1 BOX	OINTMENT	144	4
58980-012-01	Double Antibiotic	0.9 g in 1 PACKET	OINTMENT	0.9	4
58980-012-05	Double Antibiotic	14.2 g in 1 TUBE	OINTMENT	14.2	4
58980-012-05	Double Antibiotic	1 in 1 BOX	OINTMENT	1	4
58980-012-10	Double Antibiotic	28.35 g in 1 TUBE	OINTMENT	28.35	4
58980-012-10	Double Antibiotic	1 in 1 BOX	OINTMENT	1	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58980-012-01	EA - Each	58980-012	74ba8db2-0c1b-4268-906c-c36d78ae6d64	1	2020-02-13
58980-012-05	GM - Gram	58980-012	cd555393-3a0f-4bb3-9a1b-3a1c2a476b73	1	2021-03-02
58980-012-10	GM - Gram	58980-012	229bf842-dc27-4c41-8c20-c431dc24b986	1	2026-03-17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58980-012	BACITRACIN ZINC (BACITRACIN ZINC AND POLYMYXIN B SULFATE) OINTMENT [STRATUS PHARMACEUTICALS INC]	3	Current NDC, Legacy NDC, 6 package rows	20241107_f64b3564-ea3c-4316-8f00-f92c08dcad35.zip

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 17 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Triple Antibiotic plus pain relief	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Kroger Company	e31c8d92-bf9f-4b7f-8f81-54199745cd20	2024-10-06	Warnings	Exact identifier application number: M004
careone triple antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDE	American Sales Company	9df0c4c2-f045-4f25-878e-4d55a99b8df4	2024-10-06	Warnings	Exact identifier application number: M004
DG Health Antibiotic	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Dolgencorp, LLC	0a04da51-d169-4eff-b70c-352913ce3966	2024-10-06	Warnings	Exact identifier application number: M004
Signature Care Triple Antibiotic	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Safeway	8d5bac6b-98b6-4fc4-983a-ca5292b4c361	2024-10-06	Warnings	Exact identifier application number: M004
antibiotic plus pain relief	NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE	Kroger Company	91828614-d0d1-472f-802f-43f473860125	2024-09-26	Warnings	Exact identifier application number: M004
DG Health Antibiotic	NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Dolgencorp Inc	efaf3ea5-0a2f-414f-96eb-7e8cfba9e901	2024-09-26	Warnings	Exact identifier application number: M004
Good Sense First Aid Antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	A-S Medication Solutions	29c223ff-3cb7-4578-a326-08516e89cd47	2024-09-26	Warnings	Exact identifier application number: M004
Signature Care First Aid Antibiotic	NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Safeway	78ecfb28-f4c4-4f70-90c9-d6d7bf920fb5	2024-09-26	Warnings	Exact identifier application number: M004
Good Neighbor Pharmacy Antibiotic and Pain Relief	NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Amerisource Bergen	3d1694ea-3f3e-45d5-8edf-8b31ac7d3a40	2024-09-26	Warnings	Exact identifier application number: M004
Rexall Antibiotic	BACITRACIN	Dolgencorp, LLC	7ad42602-6e42-47c8-91a8-e4785fa8d24b	2024-09-23	Warnings	Exact identifier application number: M004
bacitracin	BACITRACIN	H E B	0a5eeef0-309b-4edd-a664-3d9c1c74a6e9	2024-09-23	Warnings	Exact identifier application number: M004
signature care first aid antibiotic	BACITRACIN	Safeway	38fc0c5c-e0bc-44d2-acbd-d4d329fef1e1	2024-09-23	Warnings	Exact identifier application number: M004
Antibiotic	BACITRACIN	Topco Associates LLC	3267a695-9e53-42f2-b30a-022653a0b8bb	2024-09-23	Warnings	Exact identifier application number: M004
Bacitracin	BACITRACIN	Kroger Company	4490cece-0635-4ea7-91ab-324a971fef63	2024-09-23	Warnings	Exact identifier application number: M004
triple antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	Padagis Israel Pharmaceuticals Ltd	28fff253-ddd4-4669-aa90-b4caf48c905f	2024-09-22	Warnings	Exact identifier application number: M004
Signature Care Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	Safeway	044aff98-f398-40f5-8c18-2751b4ab4384	2024-09-18	Warnings	Exact identifier application number: M004
careone triple antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	American Sales Company	09a0b0b9-1806-4ff9-80fa-448dabbf2cc7	2024-09-18	Warnings	Exact identifier application number: M004
equaline first aid antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	United Natural Foods, Inc. dba UNFI	022e009e-0192-4089-86f3-4d63448e0f88	2024-09-18	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	Kroger Company	c531bac4-ab15-4fde-99a7-19e20ce10387	2024-09-17	Warnings	Exact identifier application number: M004
basic care first aid antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	Amazon.com Services LLC	c159b18d-0d6e-409f-8b2b-e8f28cd85633	2024-09-17	Warnings	Exact identifier application number: M004

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
89Y4M234ES	BACITRACIN ZINC	1405-89-6	BACITRACIN ZINC
19371312D4	POLYMYXIN B SULFATE	1405-20-5	POLYMYXIN B SULFATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
308512	bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical Ointment	PSN	f64b3564-ea3c-4316-8f00-f92c08dcad35	4
308512	bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Topical Ointment	SCD	f64b3564-ea3c-4316-8f00-f92c08dcad35	4
308512	bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical Ointment	SY	f64b3564-ea3c-4316-8f00-f92c08dcad35	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58980-012-01	58980001201	144 PACKET in 1 BOX (58980-012-01) / .9 g in 1 PACKET	144 packet	2017-09-15	0000-00-00	No	No	Current
58980-012-05	58980001205	1 TUBE in 1 BOX (58980-012-05) / 14.2 g in 1 TUBE	1 tube	2021-02-08	0000-00-00	No	No	Current
58980-012-10	58980001210	1 TUBE in 1 BOX (58980-012-10) / 28.35 g in 1 TUBE	1 tube	2026-01-26		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Double Antibiotic Ointment	STRATUS PHARMACEUTICALS INC \| TARMAC PRODUCTS INC	2026-02-04	HUMAN OTC DRUG LABEL	4