FDA.reportPublic FDA data

BACITRACIN ZINC

Product NDC
21922-091
11-digit product format
219220091
Labeler code
21922
Product ID
21922-091_6c611a72-9cb0-421e-8c2b-2e62db9fdeac
Type
HUMAN OTC DRUG
Nonproprietary name
first aid antibiotic
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Encube Ethicals, Inc.
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-13
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
21922-091-04BACITRACIN ZINC1 in 1 CARTONOINTMENT12
21922-091-04BACITRACIN ZINC14 g in 1 TUBEOINTMENT142
21922-091-05BACITRACIN ZINC1 in 1 CARTONOINTMENT12
21922-091-05BACITRACIN ZINC28 g in 1 TUBEOINTMENT282

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21922-091-04GM - Gram21922-09158f49573-d110-4722-9c06-30e205cba44712025-11-13
21922-091-05GM - Gram21922-0911b5b33c5-2cc9-440d-aca1-727589857a5212025-11-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21922-091BACITRACIN ZINC (FIRST AID ANTIBIOTIC) OINTMENT [ENCUBE ETHICALS PRIVATE LIMITED]1Current NDC, 4 package rows20250316_613cbed4-9790-4e6b-a61b-b7b7a8ee59c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1366116bacitracin zinc 500 UNT/GM Topical OintmentPSN613cbed4-9790-4e6b-a61b-b7b7a8ee59c92
1366116bacitracin zinc 0.5 UNT/MG Topical OintmentSCD613cbed4-9790-4e6b-a61b-b7b7a8ee59c92
1366116bacitracin zinc 500 UNT per GM Topical OintmentSY613cbed4-9790-4e6b-a61b-b7b7a8ee59c92

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21922-091-04219220091041 TUBE in 1 CARTON (21922-091-04) / 14 g in 1 TUBE1 tube2025-03-13NoNoCurrent
21922-091-05219220091051 TUBE in 1 CARTON (21922-091-05) / 28 g in 1 TUBE1 tube2025-03-13NoNoCurrent