NDC 36800-410

Day Time Cold and Flu Severe

Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hci

Day Time Cold and Flu Severe is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Topco Associates Llc. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

Product ID36800-410_0fdbf571-5248-4015-8c15-1821f7c716c2
NDC36800-410
Product TypeHuman Otc Drug
Proprietary NameDay Time Cold and Flu Severe
Generic NameAcetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hci
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2016-06-13
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameTopco Associates LLC
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/1; 1/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 36800-410-04

2 BLISTER PACK in 1 CARTON (36800-410-04) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Start Date2016-06-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 36800-410-04 [36800041004]

Day Time Cold and Flu Severe CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-06-13

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

OpenFDA Data

SPL SET ID:0df6b59c-3d63-4114-86f0-10fd47135e8f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1656815
  • NDC Crossover Matching brand name "Day Time Cold and Flu Severe" or generic name "Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hci"

    NDCBrand NameGeneric Name
    36800-410Day Time Cold and Flu SevereAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCI
    55758-302SanaTos Multi SymptomAcetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCI
    55758-361SanaTos Multi SymptomAcetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCI

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