NDC 69536-175

Neo-Synephrine Extra Strength

Phenylephrine Hydrochloride

Neo-Synephrine Extra Strength is a Nasal Spray in the Human Otc Drug category. It is labeled and distributed by Foundation Consumer Healthcare Llc. The primary component is Phenylephrine Hydrochloride.

Product ID69536-175_9fc6db3a-d023-4704-8cfe-a90fb23033e7
NDC69536-175
Product TypeHuman Otc Drug
Proprietary NameNeo-Synephrine Extra Strength
Generic NamePhenylephrine Hydrochloride
Dosage FormSpray
Route of AdministrationNASAL
Marketing Start Date2017-06-30
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameFoundation Consumer Healthcare LLC
Substance NamePHENYLEPHRINE HYDROCHLORIDE
Active Ingredient Strength1 g/100mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 69536-175-15

1 BOTTLE, SPRAY in 1 CARTON (69536-175-15) > 15 mL in 1 BOTTLE, SPRAY
Marketing Start Date2017-06-30
Marketing End Date2021-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69536-175-21 [69536017521]

Neo-Synephrine Extra Strength SPRAY
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-06-30

NDC 69536-175-15 [69536017515]

Neo-Synephrine Extra Strength SPRAY
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2017-06-30

Drug Details

Active Ingredients

IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE1 g/100mL

OpenFDA Data

SPL SET ID:e37c23cf-88d4-4adc-994c-842c44951adc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1234569
  • 1087043
  • NDC Crossover Matching brand name "Neo-Synephrine Extra Strength" or generic name "Phenylephrine Hydrochloride"

    NDCBrand NameGeneric Name
    69536-175Neo-Synephrine Extra StrengthNeo-Synephrine Extra Strength
    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

    Trademark Results [Neo-Synephrine]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NEO-SYNEPHRINE
    NEO-SYNEPHRINE
    71465327 0406720 Live/Registered
    Frederick Stearns & Company
    1943-11-26

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