NATUREPLEX ANTIBIOTIC

Product NDC
67234-077
11-digit product format
672340077
Labeler code
67234
Product ID
67234-077_7ea2f689-e721-461c-aa87-0b8107889ae1
Type
HUMAN OTC DRUG
Nonproprietary name
BACITRACIN ZINC and POLYMYXIN B SULFATE
Dosage form
CREAM
Route
TOPICAL
Labeler
Natureplex LLC
Application
M004
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-09-28
Substance
BACITRACIN ZINC; POLYMYXIN B SULFATE
Active strength
500; 10000 U/14g; U/14g
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

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 productproduct67234-077UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67234-07767234-077-01UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
NATUREPLEX ANTIBIOTIC
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACITRACIN ZINC500 U/14g
POLYMYXIN B SULFATE10000 U/14g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
89Y4M234ESInternal UNII lookup
19371312D4Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
86ea3452-c810-4c9a-9f52-bcb0688020f9Available on FDA.report

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
67234-077-01NATUREPLEX ANTIBIOTIC1 in 1 CARTONCREAM12
67234-077-01NATUREPLEX ANTIBIOTIC14 g in 1 TUBECREAM142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67234-077NATUREPLEX ANTIBIOTIC (BACITRACIN ZINC AND POLYMYXIN B SULFATE) CREAM [NATUREPLEX LLC]2Current NDC, Legacy NDC, 2 package rows20250119_86ea3452-c810-4c9a-9f52-bcb0688020f9.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 20 of 22 · 424 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Triple AntibioticFIRST AID TRIPLE ANTIBIOTICCardinal Health 110,Inc.844cd9a1-b68e-47d8-a5eb-c9e880ba019e2024-01-18WarningsExact identifier
application number: M004
Multi-Action Antibiotic and Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE OINTMENTTarget Corporation8fecff32-bd67-4351-90f7-0c28cb335ea32024-01-18WarningsExact identifier
application number: M004
Leader Poly BacitracinFIRST AID ANTIBIOTICCardinal Health 110, Inc.442e11aa-7d14-44f9-bf14-446018f1de0d2024-01-18WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEUnifirst First Aid Corporation7b16cb9b-5847-4360-9974-2118f4a2c70f2024-01-17WarningsExact identifier
application number: M004
Green Guard Triple AntibioticBACITRACIN ZIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATEUnifirst First Aid Corporationbd456e2f-e6d7-d2ad-e053-2995a90a5c122024-01-17WarningsExact identifier
application number: M004
Medi-First Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEUnifirst First Aid Corporationbd432abc-fefb-1b4b-e053-2995a90acb182024-01-17WarningsExact identifier
application number: M004
Crane Safety Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATECrane Safety LLC96dbc282-4b3f-aaf3-e053-2995a90a56942024-01-17WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, AND POLYMYXIN B SULFATETarget Corporation10c4a1b5-bb91-48da-b0ae-303e4adf793a2024-01-17WarningsExact identifier
application number: M004
First Aid AntibioticBACITRACIN ZINCTarget Corporation6020956d-2f58-4be8-97da-3f6b7e0f34aa2024-01-17WarningsExact identifier
application number: M004
Triple Antibiotic and Pain ReliefTRIPLE ANTIBIOTICTarget Corporation8fda7b8a-72f3-4b92-a229-ac5be0e3b3eb2024-01-17WarningsExact identifier
application number: M004
Travel Savvy First Aid Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEBellegrove Medical Supply, Inc.69fa1c9d-5e6d-4593-e053-2a91aa0a76902024-01-16WarningsExact identifier
application number: M004
American Safety First Aid AntispeticISOPROPYL ALCOHOLOrazen Incea302ba4-a63d-e713-e053-2995a90a3fc42024-01-15WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATESled Distribution, LLCe7398df8-8e23-5439-e053-2a95a90ac3aa2024-01-15WarningsExact identifier
application number: M004
ER Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEEVER READY FIRST AID20f97e1c-584f-4844-afd8-8641ffe2f4662024-01-11WarningsExact identifier
application number: M004
Lightning X Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATENantong Health & Beyond Hygienic Products Inc.0e66af91-e0b4-827f-e063-6294a90a98472024-01-07WarningsExact identifier
application number: M004
triple antibiotic 01BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATECosmuses Cosmetics (Ningbo) Co., Ltd.0e1b23f3-fa1e-f42b-e063-6394a90a3bec2024-01-04WarningsExact identifier
application number: M004
Triple Antibiotic Ointment, Circle KTRIPLE ANTIBIOTICLil' Drug Store products, Inc.0d98477b-aa33-ebb7-e063-6294a90a597f2024-01-03WarningsExact identifier
application number: M004
Bacitracin ZincBACITRACIN ZINCTrifecta Pharmaceuticals USA LLCd9f2702c-a514-cb69-e053-2a95a90a29a92024-01-02WarningsExact identifier
application number: M004
Triple AntibioticBACITRACIN ZINC, NEOMYCIN SULFATE , POLYMYXIN B SULFATE.Geri-Care Pharmaceuticals, Corpef309620-1cf9-d007-e053-2995a90ad46f2024-01-02WarningsExact identifier
application number: M004
Bacitracin ZincBACITRACIN ZINCGeri-Care Pharmaceuticals, Corp.eec90f72-fd13-05c9-e053-2995a90a642a2024-01-02WarningsExact identifier
application number: M004

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67234-077-01672340077011 TUBE in 1 CARTON (67234-077-01) / 14 g in 1 TUBE1 tube2021-09-280000-00-00NoNoCurrent