FDA.reportPublic FDA data

POLVO DE SULFA FIRST AID ANTIBIOTIC

Product NDC
48201-105
11-digit product format
482010105
Labeler code
48201
Product ID
48201-105_42408422-e9a5-fcf0-e063-6394a90af99a
Type
HUMAN OTC DRUG
Nonproprietary name
BACITRACIN ZINC, POLYMYXIN B SULFATE
Dosage form
POWDER
Route
TOPICAL
Labeler
GRANDALL DISTRIBUTING, LLC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-18
Substance
BACITRACIN ZINC; POLYMYXIN B SULFATE
Active strength
500; 10000 [USP'U]/g; [USP'U]/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
POLVO DE SULFA FIRST AID ANTIBIOTIC
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC500 [USP'U]/g
POLYMYXIN B SULFATE10000 [USP'U]/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii89Y4M234ES, 19371312D4
Rxcui308513

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
48201-105-75POLVO DE SULFA FIRST AID ANTIBIOTIC1 in 1 BOXPOWDER12
48201-105-75POLVO DE SULFA FIRST AID ANTIBIOTIC7.5 g in 1 BOTTLEPOWDER7.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48201-105POLVO DE SULFA FIRST AID ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE) POWDER [GRANDALL DISTRIBUTING, LLC]1Current NDC, 2 package rows20240720_1d8e3a03-a39f-a99e-e063-6394a90a31db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308513bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical PowderPSN1d8e3a03-a39f-a99e-e063-6394a90a31db2
308513bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Topical PowderSCD1d8e3a03-a39f-a99e-e063-6394a90a31db2
308513bacitracin 500 UNT/GM / polymyxin B 10,000 UNT/GM Topical PowderSY1d8e3a03-a39f-a99e-e063-6394a90a31db2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
48201-105-75482010105751 BOTTLE in 1 BOX (48201-105-75) / 7.5 g in 1 BOTTLE1 bottle2024-07-18NoNoCurrent