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 16 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BACITRACIN	BACITRACIN	Meijer Distribution Inc	029e7150-1b9a-47c9-90bd-5f8bcd21365c	2024-10-29	Warnings	Exact identifier application number: M004
SUNMARK TRIPLE ANTIBIOTIC PLUS PAIN RELIEF	POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDE	A-S Medication Solutions	01131ba6-6d5b-4710-bec3-ba1769c08c79	2024-10-22	Warnings	Exact identifier application number: M004
BACITRACIN	BACITRACIN	CVS Pharmacy	15ea4415-943a-4d0a-ac23-5f37cd2cf206	2024-10-22	Warnings	Exact identifier application number: M004
Tetracyte First Aid and Antibiotic Topical	TETRACYCLINE HYDROCHLORIDE	VIADERMA DISTRIBUTION INC	dcb3d96a-41a5-40d8-a47e-56d419bbe6e2	2024-10-21	Warnings	Exact identifier application number: M004
Antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	CVS Pharmacy	3ba24e32-7078-45fb-85d1-2ab252fa9cb5	2024-10-16	Warnings	Exact identifier application number: M004
triple antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B, PRAMOXINE HCL	Meijer Distribution Inc	43486da5-6e8b-45c0-bd7e-cc2d8b28c510	2024-10-16	Warnings	Exact identifier application number: M004
Genuine First Aid First Aid Antibiotic Bacitracin Zinc	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	GFA Production (Xiamen) Co., Ltd.	af08c1fe-fb1a-56d2-e053-2a95a90a67c4	2024-10-15	Warnings	Exact identifier application number: M004
Exchange Select First Aid Triple Anitbiotic Pain Relieving	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Army & Air Force Exchange Service	1c7f1700-69c0-4a71-8bb0-a71e3082efeb	2024-10-14	Warnings	Exact identifier application number: M004
antibiotic	NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	H E B	55fa94cb-7e1c-41bc-879a-5618a828f14a	2024-10-14	Warnings	Exact identifier application number: M004
first aid antibiotic and pain relief	NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Meijer, Inc.	f0892a30-8a88-44e8-ab04-0e87c12f9c44	2024-10-14	Warnings	Exact identifier application number: M004
triple antibiotic plus pain relief	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Meijer Distribution Inc	d97a69e8-4058-4c77-b628-ad3e2b97a620	2024-10-14	Warnings	Exact identifier application number: M004
Antibiotic and Pain Relief	NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE	CVS Pharmacy	b541f1a9-7e40-4c35-840f-ea1e357b580e	2024-10-14	Warnings	Exact identifier application number: M004
Exchange Select triple antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	Army & Air Force Exchange Service	b7bf899c-44e5-48d6-bf8e-d843fd442432	2024-10-12	Warnings	Exact identifier application number: M004
topcare triple antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	Topco Associates LLC	675665ee-bd0d-4168-81b8-341b1258c102	2024-10-12	Warnings	Exact identifier application number: M004
First Aid Antibiotic	BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE	Hubei Changjian Medical Products Co., Ltd.	34e8776c-1f36-4e1b-9d71-727591ac904d	2024-10-11	Warnings	Exact identifier application number: M004
Triple Antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B	H E B	58a4d263-e234-43cd-a3bd-b19a492174d9	2024-10-11	Warnings	Exact identifier application number: M004
topcare triple antibiotic	BACITRACIN ZINC, NEOMYCIN, POLYMYXIN B, PRAMOXINE HYDROCHLORIDE	Topco Associates LLC	5e0fc39b-e6d4-4543-8afc-2881e2f85f9b	2024-10-06	Warnings	Exact identifier application number: M004
Good Sense Triple Antibiotic and Pain Relief	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	L. Perrigo Company	c3e9215f-fcef-4938-8208-df4099652289	2024-10-06	Warnings	Exact identifier application number: M004
triple antibiotic plus maximum strength	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	H E B	c428b0a3-e80a-493c-ac67-807ebca3ce01	2024-10-06	Warnings	Exact identifier application number: M004
Basic Care First Aid Antibiotic	BACITRACIN, NEOMYCIN, POLYMYXIN B, PRAMOXINE HCL	Amazon.com Services LLC	a9247f69-0366-42dd-ae0d-39a2a6976cdc	2024-10-06	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