FDA.reportPublic FDA data

Polvos de Sulpha

Product NDC
53145-304
Requested package NDC
53145-304-04
11-digit product format
531450304
Labeler code
53145
Product ID
53145-304_96217e72-407c-4866-aed3-f05c587d3676
Type
HUMAN OTC DRUG
Nonproprietary name
Bacitracin Zinc, Polymyxin B Sulfate
Dosage form
POWDER
Route
TOPICAL
Labeler
Menper Distributors Inc.
Application
part333B
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2006-12-11
Marketing end
0000-00-00
Substance
BACITRACIN ZINC; POLYMYXIN B SULFATE
Active strength
500 [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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage53145-30453145-304-04IInactivated by FDA2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53145-30453145-304-04UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage53145-30453145-304-04EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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#

Effective, Related label table
EffectiveRelated label
2023-10-19Polvos de Sulpha
2023-07-28Polvos de Sulpha
2022-02-18Polvos de Sulpha
2022-01-28Polvos de Sulpha
2020-02-07Polvos de Sulpha
2020-01-31Polvos 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.]12Legacy 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