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 56 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HAND SANITIZING LAVENDERALCOHOLDR. BRONNER'S MAGIC SOAPS8383605a-0bac-428c-b1cb-2f95ce9bd35e2025-10-28WarningsExact identifier
application number: M003
ORGANIC HAND SANITIZER PEPPERMINTALCOHOLDR. BRONNER'S MAGIC SOAPScad3a81e-88cb-4f44-a351-b086fd9837952025-10-28WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Lavender DriftETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC421cfe98-7a20-c37c-e063-6294a90ad4b52025-10-27WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Coastal CoconutETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC421ce33e-4639-e881-e063-6394a90a57ef2025-10-27WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Watermelon AloeETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC421d994c-bf62-2f40-e063-6294a90a64882025-10-27WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Peach NectarETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC421d7326-d2fd-a845-e063-6394a90a39aa2025-10-27WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sea BreezeETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC421d7bd9-c892-ec97-e063-6394a90a4b282025-10-27WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer StrawBerry ShortCakeETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC421d7326-d300-a845-e063-6394a90a39aa2025-10-27WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Vanilla CloudETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC421d8811-7fb2-aef6-e063-6394a90a1cf82025-10-27WarningsExact identifier
application number: M003
American Red Cross 70% Isopropyl AlcoholISOPROPYL ALCOHOL(70%CONC.)MY IMPORTS USA LLC421d7bd9-c893-ec97-e063-6394a90a4b282025-10-27WarningsExact identifier
application number: M003
American Red Cross AntisepticBENZALKONIUM CHLORIDE 0.13%(W/W)/BENZOCAINE 5.00%(W/W)MY IMPORTS USA LLC421dc192-97ed-0675-e063-6394a90aa1562025-10-27WarningsExact identifier
application number: M003
American Red Cross First AidBENZALKONIUM CHLORIDE 0.13%(W/W)/LIDOCAINE HCL 4.0%(W/W)MY IMPORTS USA LLC421f3150-2027-c6aa-e063-6294a90ab6aa2025-10-27WarningsExact identifier
application number: M003
American Red Cross First AidBENZALKONIUM CHLORIDE 0.13%(W/W)/LIDOCAINE HCL 4.0%(W/W)Zhejiang Guoyao Jingyue Aerosol Co., Ltd.421b402e-233d-cebf-e063-6394a90aa4212025-10-27WarningsExact identifier
application number: M003
Germ Attack Hand SanitizerALCOHOLNatural Essentials, Inc.637dcb5f-8870-4613-a227-9fd6126170612025-10-27WarningsExact identifier
application number: M003
SOURPATCH KIDS HAND SANITIZER SET WATERMELONALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd42143916-8d2e-dbbe-e063-6294a90a29c42025-10-26WarningsExact identifier
application number: M003
JOLLY RANCHER HAND SANITIZER SET CHERRYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd42147184-18e6-f932-e063-6294a90a807e2025-10-26WarningsExact identifier
application number: M003
JOLLY RANCHER HAND SANITIZER CHERRYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd4214ba08-8d00-8de9-e063-6394a90a4c902025-10-26WarningsExact identifier
application number: M003
Sour Patch Kids Hand Sanitizer WatermelonALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd4214f0de-6b1d-dae7-e063-6294a90ade422025-10-26WarningsExact identifier
application number: M003
SOURPATCH KIDS HAND SANITIZER STRAWBERRYALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd4215130c-a298-02c7-e063-6394a90a74ff2025-10-26WarningsExact identifier
application number: M003
SMARTIES ORANGE HAND SANTIZER SET ORANGE CREAMSICLEALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd421b1732-acdd-a6cc-e063-6394a90a5fb42025-10-26WarningsExact 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