FDA.reportPublic FDA data

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

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