NDC 53345-045

Cough and Cold plus

Acetaminophen, Phenylephrine Hcl, Chlorpheniramine Maleate, Dextromethorphan Hbr

Cough and Cold plus is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Humanwell Puracap Pharmaceutical (wuhan) Co., Ltd. The primary component is Acetaminophen; Phenylephrine Hydrochloride; Chlorpheniramine Maleate; Dextromethorphan Hydrobromide.

Product ID53345-045_7bc9510d-f1f4-4274-ae2e-15df159a4c66
NDC53345-045
Product TypeHuman Otc Drug
Proprietary NameCough and Cold plus
Generic NameAcetaminophen, Phenylephrine Hcl, Chlorpheniramine Maleate, Dextromethorphan Hbr
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2017-03-24
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd
Substance NameACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Active Ingredient Strength325 mg/1; mg/1; mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 53345-045-01

1 BAG in 1 BOX (53345-045-01) > 4000 CAPSULE, LIQUID FILLED in 1 BAG
Marketing Start Date2017-03-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53345-045-01 [53345004501]

Cough and Cold plus CAPSULE, LIQUID FILLED
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-03-24

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/1

OpenFDA Data

SPL SET ID:c483d88f-cb0a-4dd6-b3ae-559521782ba6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1042688
  • NDC Crossover Matching brand name "Cough and Cold plus" or generic name "Acetaminophen, Phenylephrine Hcl, Chlorpheniramine Maleate, Dextromethorphan Hbr"

    NDCBrand NameGeneric Name
    53345-045Cough and Cold plusAcetaminophen, Phenylephrine HCl, Chlorpheniramine Maleate, Dextromethorphan HBr
    69517-112AntigripAcetaminophen, Phenylephrine HCl, Chlorpheniramine Maleate, Dextromethorphan HBr

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