NDC 21130-091

Signature Care Non drowsy Daytime Severe Cold and Flu Relief

Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl

Signature Care Non drowsy Daytime Severe Cold and Flu Relief is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Safeway. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

Product ID21130-091_bcae6c74-26cb-4b06-bd8f-58f9d712dd98
NDC21130-091
Product TypeHuman Otc Drug
Proprietary NameSignature Care Non drowsy Daytime Severe Cold and Flu Relief
Generic NameAcetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2016-01-29
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameSafeway
Substance NameACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength325 mg/15mL; mg/15mL; mg/15mL; mg/15mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 21130-091-40

355 mL in 1 BOTTLE (21130-091-40)
Marketing Start Date2016-01-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 21130-091-40 [21130009140]

Signature Care non drowsy daytime severe cold and flu relief SOLUTION
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-01-29

Drug Details

Active Ingredients

IngredientStrength
ACETAMINOPHEN325 mg/15mL

OpenFDA Data

SPL SET ID:25a26577-a9f8-49cb-9d75-d8c471e4aaf6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1369842
  • NDC Crossover Matching brand name "Signature Care Non drowsy Daytime Severe Cold and Flu Relief" or generic name "Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl"

    NDCBrand NameGeneric Name
    21130-091Signature Care Non drowsy Daytime Severe Cold and Flu ReliefSignature Care Non drowsy Daytime Severe Cold and Flu Relief
    0113-7603Basic Care Daytime Cold and Flu Severeacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
    0113-7303basic care mucus relief cold flu and sore throatAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0363-0640Cold and FluAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0113-0299good sense cold and flu severeAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0113-0234good sense cold head congestionAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0113-0381Good Sense Mucus ReliefAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0113-1913good sense mucus relief cold flu and sore throatAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0113-0579good sense severe coldAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0113-0548Good Sense Severe Daytimeacetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl
    0113-0603Good Sense Severe Daytime Cold and Fluacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
    0113-9007Good Sense Severe Tussin CF MaxAcetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl
    0363-0616Mucus ReliefAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0363-0538Mucus Relief Cold Flu Sore ThroatAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0363-0719Mucus Relief Cold Flu Sore ThroatAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0363-0372Mucus Relief PlusAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0363-0410Mucus Relief Severe ColdAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0363-0503Severe ColdAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0363-0603Severe Cold and Fluacetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
    0363-0524Sinus ReliefAcetaminophen, Dextromethorphan HBR, Guaifenesin, Phenylephrine HCl
    0067-8145Theraflu ExpressMax Severe Cold and Flu CapletsAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0067-8132Theraflu ExpressMax Severe Cold and Flu SyrupAcetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
    0363-0051Wal Tussin CF MaxAcetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.