Double Antibiotic

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Double Antibiotic
Generic name: BACITRACIN ZINC AND POLYMYXIN B SULFATE
Manufacturer: STRATUS PHARMACEUTICALS INC
Product type: HUMAN OTC DRUG
SPL set ID: f64b3564-ea3c-4316-8f00-f92c08dcad35
SPL ID: 6c82f396-e1f6-4210-87b1-2615eedbdc6a
Version: 4
Effective date: 2026-02-04
Source export date: 2026-09-28
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:25:55

Harmonized routes table
Harmonized routes
TOPICAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 16 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M004	openfda.application_number
brand name		Double Antibiotic	openfda.brand_name
generic name		BACITRACIN ZINC AND POLYMYXIN B SULFATE	openfda.generic_name
manufacturer name		STRATUS PHARMACEUTICALS INC	openfda.manufacturer_name
ndc	package	58980-012-01	openfda.package_ndc
ndc	package	58980-012-10	openfda.package_ndc
ndc	package	58980-012-05	openfda.package_ndc
ndc	product	58980-012	openfda.product_ndc
ndc11	package	58980001210	derived:openfda.package_ndc
ndc11	package	58980001201	derived:openfda.package_ndc
ndc11	package	58980001205	derived:openfda.package_ndc
rxcui		308512	openfda.rxcui
spl id		6c82f396-e1f6-4210-87b1-2615eedbdc6a	id
spl set id		f64b3564-ea3c-4316-8f00-f92c08dcad35	set_id
unii		89Y4M234ES	openfda.unii
unii		19371312D4	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings for external use only Allergy alert Do not use if allergic to any of the ingredients Do not use in the eyes over large areas of the body longer than 1 week unless directed by a doctor Ask a doctor before use if you have deep or puncture wounds animal bites serious burns Stop use and ask a doctor if the condition persists or gets worse a rash or other allergic reaction develops Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Reported adverse events (FAERS/openFDA)#

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