82942-1004 NDC - TRIPLE ANTIBIOTIC (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE)

Drug Information

  • Product NDC: 82942-1004
  • Proprietary Name: Triple Antibiotic
  • Non Proprietary Name: BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE
  • Active Ingredient(s): 400 [CFU]/g BACITRACIN ZINC; 3.5 mg/g NEOMYCIN SULFATE; 5000 [CFU]/g POLYMYXIN B SULFATE
  • Administration Route(s): TOPICAL
  • Dosage Form(s): CREAM
  • Pharmacy Class(es): Aminoglycoside Antibacterial [EPC]; Aminoglycosides [CS]; Decreased Cell Wall Synthesis & Repair [PE]; Polymyxin-class Antibacterial [EPC]; Polymyxins [CS]

Labeler Information

Field Name Field Value
Labeler Name: J&A Digital Inc.
Product Type: HUMAN OTC DRUG
FDA Application Number: M004
Marketing Category: OTC MONOGRAPH DRUG
Start Marketing Date:7/31/2025

Package Information

No. Package Code Package Description Billing Unit
182942-1004-1.9 g in 1 PACKET (82942-1004-1)

NDC Record

Field Name Field Value Definition
PRODUCT NDC82942-1004This is the date that the labeler indicates was the start of its marketing of the drug product.
PRODUCT TYPE NAMEHUMAN OTC DRUGThis is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
PROPRIETARY NAMETriple AntibioticProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
NON PROPRIETARY NAMEBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATEName of Company corresponding to the labeler code segment of the Product NDC.
DOSAGE FORM NAMECREAMThe translation of the dosage form Code submitted by the firm.
ROUTE NAMETOPICALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE7/31/2025This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH DRUGProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERM004This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEJ&A Digital Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEBACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATEAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH400; 3.5; 5000 
ACTIVE INGRED UNIT[CFU]/g; mg/g; [CFU]/g 
PHARM CLASSESAminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS] 

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This page was last updated on: 12/6/2025

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