Leader Poly Bacitracin

Product NDC
70000-0093
11-digit product format
700000093
Labeler code
70000
Product ID
70000-0093_b1969426-55b8-4cae-9bb7-f641c971667e
Type
HUMAN OTC DRUG
Nonproprietary name
FIRST AID ANTIBIOTIC
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Cardinal Health 110, Inc.
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-06-01
Substance
BACITRACIN ZINC; POLYMYXIN B SULFATE
Active strength
500; 10000 [USP'U]/g; [USP'U]/g
Pharmacologic classes
Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N000004-004PAREDRINEHYDROXYAMPHETAMINE HYDROBROMIDE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Poly BacitracinFIRST AID ANTIBIOTICCardinal Health 110, Inc.442e11aa-7d14-44f9-bf14-446018f1de0d2024-01-18WarningsExact identifier

Warnings cross-check#

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

warnings

Warnings For external use only Allergy alert: do not use if you are allergic to any of the ingredients Do not use in or near the eyes on large areas of the body Consult a doctor before use if you have deep or puncture wounds animal bites serious burns When using this product do not use longer than 1 week Stop use and consult a doctor if condition persists or gets worse symptoms last for more than 7 days or clear up and come back within a few days a rash or other allergic reaction develops Keep out of the reach of children. If swallowed get medical help or contact a Poison Control Center immediately.

Additional Listing Data#

Finished product
Yes
Brand name base
Leader Poly Bacitracin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC500 [USP'U]/g
POLYMYXIN B SULFATE10000 [USP'U]/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii89Y4M234ES, 19371312D4
Rxcui308512

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0093-1Leader Poly Bacitracin14 g in 1 TUBEOINTMENT142
70000-0093-1Leader Poly Bacitracin1 in 1 CARTONOINTMENT12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0093-1GM - Gram70000-0093d76e7313-0a4a-4be9-9779-c58f56c8396112022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0093LEADER POLY BACITRACIN (FIRST AID ANTIBIOTIC) OINTMENT [CARDINAL HEALTH 110, INC.]2Current NDC, Legacy NDC, 2 package rows20240119_442e11aa-7d14-44f9-bf14-446018f1de0d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308512bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical OintmentPSN442e11aa-7d14-44f9-bf14-446018f1de0d2
308512bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Topical OintmentSCD442e11aa-7d14-44f9-bf14-446018f1de0d2
308512bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical OintmentSY442e11aa-7d14-44f9-bf14-446018f1de0d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0093-1700000093011 TUBE in 1 CARTON (70000-0093-1) / 14 g in 1 TUBE1 tube2021-06-010000-00-00NoNoCurrent