Single Antibiotic with Bacitracin

Product NDC
52412-750
11-digit product format
524120750
Labeler code
52412
Product ID
52412-750_2a807af4-eda6-de3f-e063-6394a90aeaa5
Type
HUMAN OTC DRUG
Nonproprietary name
bacitracin zinc
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Randob Labs Ltd.
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-30
Substance
BACITRACIN ZINC
Active strength
400 [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
Single Antibiotic with Bacitracin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC400 [USP'U]/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii89Y4M234ES

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
52412-750-05Single Antibiotic with Bacitracin1 in 1 BOXOINTMENT11
52412-750-05Single Antibiotic with Bacitracin14 g in 1 TUBEOINTMENT141
52412-750-10Single Antibiotic with Bacitracin28 g in 1 TUBEOINTMENT281
52412-750-10Single Antibiotic with Bacitracin1 in 1 BOXOINTMENT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52412-750SINGLE ANTIBIOTIC WITH BACITRACIN (BACITRACIN ZINC) OINTMENT [RANDOB LABS LTD.]1Current NDC, 4 package rows20250101_2a807f1b-986f-a9ea-e063-6394a90aed25.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
52412-750-05524120750051 TUBE in 1 BOX (52412-750-05) / 14 g in 1 TUBE1 tube2024-12-30NoNoCurrent
52412-750-10524120750101 TUBE in 1 BOX (52412-750-10) / 28 g in 1 TUBE1 tube2024-12-30NoNoCurrent