NDC 41520-831

CareOne Cold and Sinus

Phenylephrine Hydrochloride

CareOne Cold and Sinus is a Nasal Solution/ Drops in the Human Otc Drug category. It is labeled and distributed by American Sales Company. The primary component is Phenylephrine Hydrochloride.

Product ID41520-831_0f60cb21-8931-4f02-943f-4fc3d23f6545
NDC41520-831
Product TypeHuman Otc Drug
Proprietary NameCareOne Cold and Sinus
Generic NamePhenylephrine Hydrochloride
Dosage FormSolution/ Drops
Route of AdministrationNASAL
Marketing Start Date2016-10-20
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameAmerican Sales Company
Substance NamePHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength1 g/100mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 41520-831-10

1 BOTTLE in 1 CARTON (41520-831-10) > 30 mL in 1 BOTTLE
Marketing Start Date2016-10-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 41520-831-10 [41520083110]

CareOne Cold and Sinus SOLUTION/ DROPS
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2016-10-20

Drug Details

Active Ingredients

IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE1 g/100mL

OpenFDA Data

SPL SET ID:f7b4c55a-f31c-4418-81a1-2f3193f6f9d3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1087043

    • NDC Crossover Matching brand name "CareOne Cold and Sinus" or generic name "Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    41520-783CareOne Cold and SinusCareOne Cold and Sinus
    41520-831CareOne Cold and SinusCareOne Cold and Sinus
    0067-20864 WayPhenylephrine hydrochloride
    0113-7094basic care sinus pePhenylephrine Hydrochloride
    0363-0390ephrine nosePhenylephrine hydrochloride
    0363-2023Ephrine Nose DropsPhenylephrine hydrochloride
    0113-0094Good Sense Nasal Decongestant PEPhenylephrine Hydrochloride
    0113-0648Good Sense Nasal FourPhenylephrine hydrochloride
    0295-1217Little Remedies Decongestant Nose DropsPhenylephrine Hydrochloride
    0363-0717nasalPhenylephrine hydrochloride
    0295-1117Neo-SynephrinePhenylephrine hydrochloride
    0295-1118Neo-SynephrinePhenylephrine hydrochloride
    0295-1119Neo-SynephrinePhenylephrine hydrochloride
    0225-0800Neo-Synephrine MildPHENYLEPHRINE HYDROCHLORIDE
    0225-0805Neo-Synephrine RegularPHENYLEPHRINE HYDROCHLORIDE
    0225-0810Neo-Synephrine RegularPHENYLEPHRINE HYDROCHLORIDE
    0363-0394phenylephrine hydrochloridephenylephrine hydrochloride
    0404-9931Phenylephrine HydrochloridePhenylephrine Hydrochloride
    0641-6142Phenylephrine HydrochloridePhenylephrine Hydrochloride
    0641-6188Phenylephrine HydrochloridePhenylephrine Hydrochloride
    0641-6189Phenylephrine HydrochloridePhenylephrine Hydrochloride
    0641-6229Phenylephrine HydrochloridePhenylephrine Hydrochloride
    0781-3422Phenylephrine HydrochloridePhenylephrine Hydrochloride
    0781-3458Phenylephrine HydrochloridePhenylephrine Hydrochloride
    0113-2004sinus PEPhenylephrine Hydrochloride
    0363-0648Wal FourPhenylephrine hydrochloride
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.