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 69 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Hand Sanitizer Cherry Blossom 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2869cb20-9cd4-54f5-e063-6294a90a5fea2025-09-05WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Vanilla Sugar 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.28694168-3362-de4f-e063-6394a90a2e352025-09-05WarningsExact identifier
application number: M003
Smart Care Cucumber Melon Hand SanitizerALCOHOLShenzhen Lantern Scicence Co.,Ltd.3e0a5382-7b58-fd6e-e063-6394a90abf662025-09-05WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer WatermelonALCOHOLShenzhen Lantern Scicence Co.,Ltd.3e09c0aa-0241-0816-e063-6294a90a481e2025-09-05WarningsExact identifier
application number: M003
Smart Care Sweet Pea Hand Sanitizer sweet pea 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.3080d8a2-a780-e79b-e063-6294a90ac6542025-09-05WarningsExact identifier
application number: M003
Smart Care 1oz Hand Sanitizer Japanese Cherry Blossom 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.3081e1b5-66b4-77a8-e063-6394a90a8dd32025-09-05WarningsExact identifier
application number: M003
Smart Care 1oz Hand Sanitizer Island Mango 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.30847dd5-e378-1a35-e063-6294a90a43da2025-09-05WarningsExact identifier
application number: M003
Smart Care 1oz Hand Sanitizer Vanilla Heaven 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.3084d980-29ca-91ca-e063-6294a90a6c672025-09-05WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer 3pk 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.3099e6af-8072-d26b-e063-6394a90a39ef2025-09-05WarningsExact identifier
application number: M003
Povidone Iodine PrepPOVIDONE IODINESion Biotext Medical Ltde05af551-647d-4278-bb7f-86f888ddbb8b2025-09-04WarningsExact identifier
application number: M003
X3 CleanBENZALKONIUM CHLORIDEX3 Labs Inc.a8eedcfd-3b97-497a-9a34-d59b0dd784392025-09-03WarningsExact identifier
application number: M003
X3 CleanBENZALKONIUM CHLORIDEX3 Labs Inc.40cc6501-3cee-24cc-e054-00144ff88e882025-09-03WarningsExact identifier
application number: M003
5OCT ANTIBACTERL HAND WIPES5OCT ANTIBACTERL HAND WIPESJinhua Aidi Daily Chemical Co., Ltd.3dbd8ca9-1ca0-ac4f-e063-6394a90a3cfa2025-09-01WarningsExact identifier
application number: M003
AeroWipeSTING RELIEF PADAero Healthcare US LLC3d851c98-c9b9-f084-e063-6294a90acde22025-08-29WarningsExact identifier
application number: M003
wet wipes 01BENZALKONIUM CHLORIDECosmuses Cosmetics (Ningbo) Co., Ltd.3d3d7e8b-1ec1-9f9f-e063-6294a90ade0e2025-08-25WarningsExact identifier
application number: M003
Solar Flare Hand Sanitizer Brazilian Caramel DreamsALCOHOLScent Theory Products LLC3d0d4ccf-ea31-cab2-e063-6294a90a4c692025-08-23WarningsExact identifier
application number: M003
Solar Flare Hand Sanitizer Sunset SambaALCOHOLScent Theory Products LLC3d0d7d6b-33a0-5cd1-e063-6394a90ac8f62025-08-23WarningsExact identifier
application number: M003
Solar Flare Hand Sanitizer Set Sea Veil, Pink Glow, Coco CremeALCOHOLScent Theory Products LLC3d0d7e73-8a83-9577-e063-6294a90aff6c2025-08-23WarningsExact identifier
application number: M003
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCITrifecta Pharmaceuticals USA LLCfe439c60-5a02-648f-e053-6294a90a14032025-08-23WarningsExact identifier
application number: M003
OP-First Aid Series ALCOHOL PREP PADS STERILEISOPROPYL ALCOHOL CLOTHYiwu Ori-Power Medtech Co.,Ltd.351f4b1e-75c9-abec-e063-6294a90a28752025-08-22WarningsExact 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