FDA.reportPublic FDA data

Bacitracin Zinc

Product NDC
68001-531
11-digit product format
680010531
Labeler code
68001
Product ID
68001-531_097e2efb-9a02-c6e6-e063-6294a90a6d7d
Type
HUMAN OTC DRUG
Nonproprietary name
First Aid Antibiotic
Dosage form
OINTMENT
Route
TOPICAL
Labeler
BluePoint Laboratories
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-03-04
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

Additional Listing Data#

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

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii89Y4M234ES
Rxcui1366116

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
68001-531-45Bacitracin Zinc1 in 1 CARTONOINTMENT13
68001-531-45Bacitracin Zinc14.2 g in 1 TUBEOINTMENT14.23
68001-531-46Bacitracin Zinc28.4 g in 1 TUBEOINTMENT28.43
68001-531-46Bacitracin Zinc1 in 1 CARTONOINTMENT13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-531-45GM - Gram68001-531a96fcb75-6839-4c25-8b48-89c07ab36f0a12022-08-04
68001-531-46GM - Gram68001-531e0eea779-b81a-494a-928f-923e2f04376a12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-531BACITRACIN ZINC (FIRST AID ANTIBIOTIC) OINTMENT [BLUEPOINT LABORATORIES]3Current NDC, Legacy NDC, 4 package rows20231118_d914abe1-5e14-5673-e053-2a95a90ac91b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1366116bacitracin zinc 500 UNT/GM Topical OintmentPSNd914abe1-5e14-5673-e053-2a95a90ac91b3
1366116bacitracin zinc 0.5 UNT/MG Topical OintmentSCDd914abe1-5e14-5673-e053-2a95a90ac91b3
1366116bacitracin zinc 500 UNT per GM Topical OintmentSYd914abe1-5e14-5673-e053-2a95a90ac91b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-531-45680010531451 TUBE in 1 CARTON (68001-531-45) / 14.2 g in 1 TUBE1 tube2022-03-040000-00-00NoNoCurrent
68001-531-46680010531461 TUBE in 1 CARTON (68001-531-46) / 28.4 g in 1 TUBE1 tube2022-03-040000-00-00NoNoCurrent