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Drug Information

Product NDC: 66513-468

Proprietary Name: Broncolin


Active Ingredient(s):
  • 325 mg/1 ACETAMINOPHEN;

Administration Route(s): ORAL


Pharmacy Class(es):
  • Adrenergic alpha1-Agonists [MoA];
  • Sigma-1 Agonist [EPC];
  • Sigma-1 Receptor Agonists [MoA];
  • Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC];
  • Uncompetitive NMDA Receptor Antagonists [MoA];
  • alpha-1 Adrenergic Agonist [EPC]

Labeler Information

Labeler Name: Broncolin S.A de C.V.
Product Type: HUMAN OTC DRUG
FDA Application Number: part341
Marketing Category: OTC MONOGRAPH FINAL
Start Marketing Date:4/30/2016
End Marketing Date:12/29/2023

Package Information

No. Package Code Package Description Billing Unit
166513-468-1212 BLISTER PACK in 1 CARTON (66513-468-12) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

NDC Record

Field Name Field Value Definition
PRODUCT NDC66513-468The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN OTC DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEBroncolinThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAME SUFFIXCold and Flu ReliefA suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
NON PROPRIETARY NAMEACETAMINOHPEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HClThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMECAPSULE, LIQUID FILLEDThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE4/30/2016This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE12/29/2023This 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.
MARKETING CATEGORY NAMEOTC MONOGRAPH FINALProduct 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 under Structured Product Labeling Resources.
APPLICATION NUMBERpart341This 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 NAMEBroncolin S.A de C.V.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDEAn 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 INGRED UNITmg/1; mg/1; mg/1 
PHARM CLASSESAdrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC] 

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This page was last updated on: 2/1/2023