Single Antibiotic

Product NDC
61010-4404
11-digit product format
610104404
Labeler code
61010
Product ID
61010-4404_115cae29-9471-815f-e063-6294a90a25aa
Type
HUMAN OTC DRUG
Nonproprietary name
bacitracin zinc
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Safetec of America, Inc.
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-11-01
Substance
BACITRACIN ZINC
Active strength
500 [iU]/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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC500 [iU]/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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61010-4404-12024-02-14C16284748780-11030e365-65a3-111a-e063-dadaa90a10e261010-4404 Triple Antibiotic with Pain Relief
61010-4404-12024-01-30C16284748780-11030e365-65a3-111a-e063-dadaa90a10e261010-4404 Triple Antibiotic with Pain Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61010-4404-1Single Antibiotic28.4 g in 1 TUBEOINTMENT28.42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61010-4404SINGLE ANTIBIOTIC (BACITRACIN ZINC) OINTMENT [SAFETEC OF AMERICA, INC.]2Current NDC, Legacy NDC, 1 package rows20240215_9993c204-6e61-4da3-90ef-2b7dfa09c920.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1366116bacitracin zinc 500 UNT/GM Topical OintmentPSN9993c204-6e61-4da3-90ef-2b7dfa09c9202
1366116bacitracin zinc 0.5 UNT/MG Topical OintmentSCD9993c204-6e61-4da3-90ef-2b7dfa09c9202
1366116bacitracin zinc 500 UNT per GM Topical OintmentSY9993c204-6e61-4da3-90ef-2b7dfa09c9202

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61010-4404-16101044040128.4 g in 1 TUBE (61010-4404-1) 28.4 g2019-11-010000-00-00NoNoCurrent