FDA.reportPublic FDA data

Polvos de Sulpha

Product NDC
53145-304
11-digit product format
531450304
Labeler code
53145
Product ID
53145-304_2b362c67-d115-fb81-e063-6394a90aeb65
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc, Polymyxin B Sulfate
Dosage form
POWDER
Route
TOPICAL
Labeler
Menper Distributors Inc.
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2006-12-11
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
Polvos de Sulpha
Brand name suffix
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53145-304-042023-10-19C16284748780-19d75b9d1-006c-f424-e053-dadaa90a57cePolvos de Sulpha
53145-304-042023-07-28C16284748780-19d75b9d1-006c-f424-e053-dadaa90a57cePolvos de Sulpha
53145-304-042022-02-18C16284748780-19d75b9d1-006c-f424-e053-dadaa90a57cePolvos de Sulpha
53145-304-042022-01-28C16284748780-19d75b9d1-006c-f424-e053-dadaa90a57cePolvos de Sulpha
53145-304-042020-02-07C16284748780-19d75b9d1-006c-f424-e053-dadaa90a57cePolvos de Sulpha
53145-304-042020-01-31C16284748780-19d75b9d1-006c-f424-e053-dadaa90a57cePolvos de Sulpha

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53145-304-04Polvos de SulphaFirst Aid Antibiotic7.5 g in 1 BOTTLE, PLASTICPOWDER7.512

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACITRACIN ZINCACTIVE INGREDIENT89Y4M234ESPOLVOS DE SULPHA FIRST AID ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE) POWDER [MENPER DISTRIBUTORS INC.]4
POLYMYXIN B SULFATEACTIVE INGREDIENT19371312D4POLVOS DE SULPHA FIRST AID ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE) POWDER [MENPER DISTRIBUTORS INC.]4
BACITRACIN ZINCACTIVE MOIETY89Y4M234ESPOLVOS DE SULPHA FIRST AID ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE) POWDER [MENPER DISTRIBUTORS INC.]4
POLYMYXIN BACTIVE MOIETYJ2VZ07J96KPOLVOS DE SULPHA FIRST AID ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE) POWDER [MENPER DISTRIBUTORS INC.]4
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GPOLVOS DE SULPHA FIRST AID ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE) POWDER [MENPER DISTRIBUTORS INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53145-304POLVOS DE SULPHA FIRST AID ANTIBIOTIC (BACITRACIN ZINC, POLYMYXIN B SULFATE) POWDER [MENPER DISTRIBUTORS INC.]12Current NDC, Legacy NDC, 1 package rows20250116_511b52e9-c112-4519-a567-dc9f433c4f37.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308513bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical PowderPSN511b52e9-c112-4519-a567-dc9f433c4f3712
308513bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Topical PowderSCD511b52e9-c112-4519-a567-dc9f433c4f3712
308513bacitracin 500 UNT/GM / polymyxin B 10,000 UNT/GM Topical PowderSY511b52e9-c112-4519-a567-dc9f433c4f3712

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53145-304-04531450304047.5 g in 1 BOTTLE, PLASTIC (53145-304-04) 7.5 g2006-12-110000-00-00NoNoCurrent