FDA.reportPublic FDA data

Drs. Antibiotic Bacitracin

Product NDC
80489-006
11-digit product format
804890006
Labeler code
80489
Product ID
80489-006_2b5219ec-a6ca-f405-e063-6294a90ab2c6
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin
Dosage form
OINTMENT
Route
TOPICAL
Labeler
OL PHARMA TECH, LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-10-01
Substance
BACITRACIN ZINC
Active strength
500 [USP'U]/g
Pharmacologic classes
Decreased Cell Wall Synthesis & Repair [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
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
Drs. Antibiotic Bacitracin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC500 [USP'U]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
89Y4M234ESInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1366116Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c26493c4-0bc1-5fdc-e053-2995a90a81e6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80489-006-01Drs. Antibiotic Bacitracin1 in 1 CARTONOINTMENT14
80489-006-01Drs. Antibiotic Bacitracin14 g in 1 TUBEOINTMENT144
80489-006-02Drs. Antibiotic Bacitracin1 in 1 CARTONOINTMENT14
80489-006-02Drs. Antibiotic Bacitracin28.3 g in 1 TUBEOINTMENT28.34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80489-006DRS. ANTIBIOTIC BACITRACIN (BACITRACIN) OINTMENT [OL PHARMA TECH, LLC]4Current NDC, Legacy NDC, 4 package rows20250112_c26493c4-0bc1-5fdc-e053-2995a90a81e6.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 99 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand Sanitizer LavenderETHYL ALCOHOLWhole Foods Market, Inc.0742f251-5fc9-c015-e063-6394a90a79b12024-11-02WarningsExact identifier
application number: M003
Hand Sanitizer Orange BlossomETHYL ALCOHOLWhole Foods Market, Inc.07436407-7a15-7cee-e063-6294a90a96512024-11-02WarningsExact identifier
application number: M003
Hand Sanitizer LavenderETHYL ALCOHOLWhole Foods Market, Inc.07f7e966-e57e-dede-e063-6294a90acbf52024-11-02WarningsExact identifier
application number: M003
Hand Sanitizer LavenderETHYL ALCOHOLWhole Foods Market, Inc.ec8c7597-a3f1-65a8-e053-2995a90a69a12024-11-02WarningsExact identifier
application number: M003
Lemongrass Hand SanitizerALCOHOLNatural Essentials, Inc.25ca3908-24aa-5e4f-e063-6394a90a7a882024-10-31WarningsExact identifier
application number: M003
Sanar Naturals Decolorized IodineETHYL ALCOHOLSanvall Enterprises, Inc16c92427-84d2-cad5-e063-6394a90af4352024-10-31WarningsExact identifier
application number: M003
Sanar Naturals MercurochromeBENZALKONIUM CHLOLRIDESanvall Enterprises, Inc16c6c2f0-0f08-e640-e063-6394a90aa01d2024-10-31WarningsExact identifier
application number: M003
Sanar Naturals Gentian VioletGENTIAN VIOLETSanvall Enterprises, Inc1922518d-e49b-5010-e063-6394a90a91122024-10-31WarningsExact identifier
application number: M003
Lavender Hand SanitizerALCOHOLNatural Essentials, Inc.25cada8c-8c80-c140-e063-6294a90a33362024-10-31WarningsExact identifier
application number: M003
Peppermint Hand SanitizerALCOHOLNatural Essentials, Inc.25cb382a-6e66-05e6-e063-6294a90a91652024-10-31WarningsExact identifier
application number: M003
RITE AID Maximum strength pain relievingBENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDERITE AIDc87671cb-d736-4ec6-ab10-94dff54925b22024-10-30WarningsExact identifier
application number: M003
H2OCEAN NOTHINGBENZALKONIUM CL, LIDOCAINE HCLH2Ocean, LLC77896ac3-960c-41ac-8b40-053f24526fe32024-10-23WarningsExact identifier
application number: M003
Blue Green FoamBENZALKONIUM CHLORIDEH2Ocean, LLC8627bf8b-2cce-45de-b37f-8478462645fa2024-10-23WarningsExact identifier
application number: M003
CVS HEALTH CONTINUOUS HAND SANITIZERALCOHOLCVS PHARMACYc89a28ac-ab53-46dd-e053-2a95a90a32842024-10-22WarningsExact identifier
application number: M003
TRADER JOES HAND SANITIZER LAVENDERETHYL ALCOHOLTrader Joe's Company4d782831-dab8-4553-9786-b5172813553e2024-10-22WarningsExact identifier
application number: M003
TRADER JOES HAND SANITIZER GRAPEFRUIT LEMONALCOHOLTrader Joe's Companyf4c1e80a-847b-4407-92b7-570c032bea602024-10-22WarningsExact identifier
application number: M003
Isopropyl Rubbing Alcohol 99%ISOPROPYL ALCOHOLUniversal Distribution Center LLC678a9b14-2838-4358-9673-fc23e0f58efb2024-10-21WarningsExact identifier
application number: M003
Isopropyl Rubbing Alcohol 70%ISOPROPYL ALCOHOLUniversal Distribution Center LLCa9960d2f-f13a-4168-b2e9-d6f4a35d84ae2024-10-21WarningsExact identifier
application number: M003
Isopropyl Rubbing Alcohol 50%ISOPROPYL ALCOHOLUniversal Distribution Center LLC5db1659e-3a13-47f0-90ae-f8f192c6111a2024-10-21WarningsExact identifier
application number: M003
Isopropyl Rubbing Alcohol 70% with WintergreenISOPROPYL ALCOHOLUniversal Distribution Center LLC3dcdc1cc-ece8-4b47-a236-ee57c375bb992024-10-21WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1366116bacitracin zinc 500 UNT/GM Topical OintmentPSNc26493c4-0bc1-5fdc-e053-2995a90a81e64
1366116bacitracin zinc 0.5 UNT/MG Topical OintmentSCDc26493c4-0bc1-5fdc-e053-2995a90a81e64
1366116bacitracin zinc 500 UNT per GM Topical OintmentSYc26493c4-0bc1-5fdc-e053-2995a90a81e64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80489-006-01804890006011 TUBE in 1 CARTON (80489-006-01) / 14 g in 1 TUBE1 tube2021-10-010000-00-00NoNoCurrent
80489-006-02804890006021 TUBE in 1 CARTON (80489-006-02) / 28.3 g in 1 TUBE1 tube2021-10-010000-00-00NoNoCurrent