NDC 37000-434

Vicks Sinex 12 Hour Decongestant

Oxymetazoline Hydrochloride

Vicks Sinex 12 Hour Decongestant is a Nasal Spray in the Human Otc Drug category. It is labeled and distributed by The Procter & Gamble Manufacturing Company. The primary component is Oxymetazoline Hydrochloride.

Product ID37000-434_432b62ee-59b7-12c3-e054-00144ff8d46c
NDC37000-434
Product TypeHuman Otc Drug
Proprietary NameVicks Sinex 12 Hour Decongestant
Generic NameOxymetazoline Hydrochloride
Dosage FormSpray
Route of AdministrationNASAL
Marketing Start Date2015-04-27
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameThe Procter & Gamble Manufacturing Company
Substance NameOXYMETAZOLINE HYDROCHLORIDE
Active Ingredient Strength0 g/mL
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 37000-434-01

1 BOTTLE, PUMP in 1 CARTON (37000-434-01) > 15 mL in 1 BOTTLE, PUMP
Marketing Start Date2015-04-27
Marketing End Date2021-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 37000-434-01 [37000043401]

Vicks Sinex 12 Hour Decongestant SPRAY
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2015-04-27
Marketing End Date2021-06-01

Drug Details

Active Ingredients

IngredientStrength
OXYMETAZOLINE HYDROCHLORIDE.0005095 g/mL

OpenFDA Data

SPL SET ID:6d8ee14e-570f-4be6-8231-7bde6d823914
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1000990
  • 1001066
  • NDC Crossover Matching brand name "Vicks Sinex 12 Hour Decongestant" or generic name "Oxymetazoline Hydrochloride"

    NDCBrand NameGeneric Name
    37000-434Vicks Sinex 12 Hour DecongestantVicks Sinex 12 Hour Decongestant
    10202-3047 Select Nasaloxymetazoline hydrochloride
    10202-8497 Select Original NasalOxymetazoline Hydrochloride
    11523-1159AfrinOxymetazoline hydrochloride
    11523-0073Afrin Allergy Sinus Nasaloxymetazoline hydrochloride
    11523-1160Afrin No Drip Nightoxymetazoline hydrochloride
    11523-0034Afrin NoDrip Allergy Sinus Nightoxymetazoline hydrochloride
    0363-0304Anefrin Nasaloxymetazoline hydrochloride
    0113-7388basic care nasalOxymetazoline Hydrochloride
    0113-7494basic care no drip nasalOxymetazoline hydrochloride
    11523-0091Children Afrin Extra Moisturizing Stuffy Nose Pump MistOxymetazoline hydrochloride
    11523-0090Children Afrin No Drip Extra Moisturizing Stuffy Nose Pump MistOxymetazoline hydrochloride
    0573-1191DRISTAN 12 HRoxymetazoline hydrochloride
    0113-0304Good Sense Nasaloxymetazoline hydrochloride
    0113-0817Good Sense Nasaloxymetazoline hydrochloride
    0113-2304Nasaloxymetazoline hydrochloride
    0904-5711NasalOxymetazoline Hydrochloride
    0536-5005Nasal ReliefOxymetazoline Hydrochloride
    0363-7007No Drip Anefrin NasalOXYMETAZOLINE HYDROCHLORIDE
    0023-5300RHOFADEOxymetazoline Hydrochloride
    0363-2021Severe AnefrinOXYMETAZOLINE HYDROCHLORIDE
    0363-7009Severe Sinus Relief Mistoxymetazoline hydrochloride
    10237-464Zicam Extreme Congestion Reliefoxymetazoline hydrochloride
    10237-471Zicam Intense Sinus Reliefoxymetazoline hydrochloride

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