NDC 65131-097

BRONCOCHEM COLD AND FLU TEA

Acetaminophen-phenylephrine Hydrochloride-chlorpheniramine Maleate

BRONCOCHEM COLD AND FLU TEA is a Oral Granule, For Solution in the Human Otc Drug category. It is labeled and distributed by Laboratorio Magnachem International Srl. The primary component is Acetaminophen; Chlorpheniramine Maleate.

Product ID65131-097_6634cf8a-9769-40ea-9da6-b56f00d1013d
NDC65131-097
Product TypeHuman Otc Drug
Proprietary NameBRONCOCHEM COLD AND FLU TEA
Generic NameAcetaminophen-phenylephrine Hydrochloride-chlorpheniramine Maleate
Dosage FormGranule, For Solution
Route of AdministrationORAL
Marketing Start Date2013-09-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart343
Labeler NameLABORATORIO MAGNACHEM INTERNATIONAL SRL
Substance NameACETAMINOPHEN; CHLORPHENIRAMINE MALEATE
Active Ingredient Strength500 mg/13g; mg/13g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 65131-097-12

25 PACKAGE in 1 BOX (65131-097-12) > 13 g in 1 PACKAGE (65131-097-52)
Marketing Start Date2017-09-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65131-097-52 [65131009752]

BRONCOCHEM COLD AND FLU TEA GRANULE, FOR SOLUTION
Marketing CategoryOTC monograph not final
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-09-01

NDC 65131-097-12 [65131009712]

BRONCOCHEM COLD AND FLU TEA GRANULE, FOR SOLUTION
Marketing CategoryOTC monograph not final
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-09-28

NDC 65131-097-53 [65131009753]

BRONCOCHEM COLD AND FLU TEA GRANULE, FOR SOLUTION
Marketing CategoryOTC monograph not final
Application Numberpart343
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-09-28

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN500 mg/13g

OpenFDA Data

SPL SET ID:b7d3f54e-59ef-4b85-a88d-b053058dc1f6
Manufacturer
UNII

Trademark Results [BRONCOCHEM]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BRONCOCHEM
BRONCOCHEM
85365505 4102132 Live/Registered
Global Corporation
2011-07-07
BRONCOCHEM
BRONCOCHEM
75813839 2405940 Dead/Cancelled
GLOBAL CORPORATION
1999-10-04

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