NDC 48083-330

CERTI-SINE

Phenylephrine Hydrochloride

CERTI-SINE is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Certified Safety Manufacturing. The primary component is Phenylephrine Hydrochloride.

Product ID48083-330_262daeb0-6a7b-4fc6-b010-75b22c86c7f8
NDC48083-330
Product TypeHuman Otc Drug
Proprietary NameCERTI-SINE
Generic NamePhenylephrine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-12-29
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameCertified Safety Manufacturing
Substance NamePHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength5 mg/1
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 48083-330-41

1000 POUCH in 1 BOX (48083-330-41) > 2 TABLET in 1 POUCH
Marketing Start Date2017-12-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 48083-330-31 [48083033031]

CERTI-SINE TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-12-29
Inactivation Date2020-01-31

NDC 48083-330-41 [48083033041]

CERTI-SINE TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-12-29
Inactivation Date2020-01-31

NDC 48083-330-33 [48083033033]

CERTI-SINE TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-12-29
Inactivation Date2020-01-31

NDC 48083-330-36 [48083033036]

CERTI-SINE TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-12-29
Inactivation Date2020-01-31

NDC 48083-330-30 [48083033030]

CERTI-SINE TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-12-29
Inactivation Date2020-01-31

NDC 48083-330-39 [48083033039]

CERTI-SINE TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-12-29
Inactivation Date2020-01-31

NDC 48083-330-27 [48083033027]

CERTI-SINE TABLET
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-12-29
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

OpenFDA Data

SPL SET ID:6825b90f-133c-457d-b75b-4a630c0a2030
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1299145
  • NDC Crossover Matching brand name "CERTI-SINE" or generic name "Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    48083-330CERTI-SINECERTI-SINE
    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

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