NDC 58596-002

Cold Medicine XL3 FORTE

Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride

Cold Medicine XL3 FORTE is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Selgel M. The primary component is Acetaminophen; Chlorpheniramine Maleate; Phenylephrine Hydrochloride.

Product ID58596-002_81419cf2-0df8-ed82-e053-2a91aa0a1623
NDC58596-002
Product TypeHuman Otc Drug
Proprietary NameCold Medicine XL3 FORTE
Generic NameAcetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-08-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameSelgel M
Substance NameACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 58596-002-10

1 BLISTER PACK in 1 BOX (58596-002-10) > 10 TABLET in 1 BLISTER PACK (58596-002-01)
Marketing Start Date2018-10-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58596-002-20 [58596000220]

Cold Medicine XL3 FORTE TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-08-01

NDC 58596-002-04 [58596000204]

Cold Medicine XL3 FORTE TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-08-01

NDC 58596-002-02 [58596000202]

Cold Medicine XL3 FORTE TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-08-01

NDC 58596-002-50 [58596000250]

Cold Medicine XL3 FORTE TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-08-01

NDC 58596-002-01 [58596000201]

Cold Medicine XL3 FORTE TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-08-01

NDC 58596-002-10 [58596000210]

Cold Medicine XL3 FORTE TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2018-10-12

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

OpenFDA Data

SPL SET ID:8141a01a-4be7-fc1c-e053-2991aa0a8e4c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1193293

    • NDC Crossover Matching brand name "Cold Medicine XL3 FORTE" or generic name "Acetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride"

    NDCBrand NameGeneric Name
    58596-002Cold MedicineAcetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride
    63654-600Cold MedicineAcetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride
    63654-601Cold MedicineAcetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride
    63654-605Cold MedicineAcetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride
    76095-010Cold MedicineAcetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride
    76095-011Cold MedicineAcetaminophen Chlorpheniramine Maleate Phenylepherine Hydrochloride
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