Antibiotic

Product NDC
51316-044
11-digit product format
513160044
Labeler code
51316
Product ID
51316-044_50187929-7372-4b3d-939d-d13be4dc4b51
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc, Polymyxin B Sulfate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
CVS PHARMACY, INC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-02-25
Substance
BACITRACIN ZINC; POLYMYXIN B SULFATE
Active strength
500; 10000 [iU]/g; [iU]/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
Antibiotic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC500 [iU]/g
POLYMYXIN B SULFATE10000 [iU]/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
51316-044-01Antibiotic28 g in 1 TUBEOINTMENT283
51316-044-01Antibiotic1 in 1 CARTONOINTMENT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-044ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE) OINTMENT [CVS PHARMACY, INC]3Current NDC, Legacy NDC, 2 package rows20240316_32e92acf-2e48-4933-8e08-e1df650e7d19.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308512bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical OintmentPSN32e92acf-2e48-4933-8e08-e1df650e7d193
308512bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Topical OintmentSCD32e92acf-2e48-4933-8e08-e1df650e7d193
308512bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical OintmentSY32e92acf-2e48-4933-8e08-e1df650e7d193

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51316-044-01513160044011 TUBE in 1 CARTON (51316-044-01) / 28 g in 1 TUBE1 tube2022-02-250000-00-00NoNoCurrent