BACITRACIN ZINC

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: BACITRACIN ZINC
Generic name: BACITRACIN ZINC
Manufacturer: STRATUS PHARMACEUTICALS INC
Product type: HUMAN OTC DRUG
SPL set ID: b2cb3a96-b0ca-42ee-8056-91d5450fb376
SPL ID: 989398c9-b804-46c7-b8bf-20d9dabcb245
Version: 3
Effective date: 2024-10-31
Source export date: 2026-10-12
Source partition: 11
Source file: https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:46:38

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 · 13 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M005	openfda.application_number
brand name		BACITRACIN ZINC	openfda.brand_name
generic name		BACITRACIN ZINC	openfda.generic_name
manufacturer name		STRATUS PHARMACEUTICALS INC	openfda.manufacturer_name
ndc	package	58980-011-01	openfda.package_ndc
ndc	package	58980-011-10	openfda.package_ndc
ndc	product	58980-011	openfda.product_ndc
ndc11	package	58980001101	derived:openfda.package_ndc
ndc11	package	58980001110	derived:openfda.package_ndc
rxcui		1366116	openfda.rxcui
spl id		989398c9-b804-46c7-b8bf-20d9dabcb245	id
spl set id		b2cb3a96-b0ca-42ee-8056-91d5450fb376	set_id
unii		89Y4M234ES	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 Ask a doctor before use if you have deep or puncture wounds animal bites serious burns When using this product do not use longer then one week unless directed by doctor Stop use and ask a doctor if condition persists or gets worse a rash or other allergic reaction develop 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.