NDC 0573-1191

DRISTAN 12 HR

Oxymetazoline Hydrochloride

DRISTAN 12 HR is a Nasal Spray in the Human Otc Drug category. It is labeled and distributed by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The primary component is Oxymetazoline Hydrochloride.

Product ID0573-1191_267c4196-ee61-4c44-995c-86d1aaf24679
NDC0573-1191
Product TypeHuman Otc Drug
Proprietary NameDRISTAN 12 HR
Generic NameOxymetazoline Hydrochloride
Dosage FormSpray
Route of AdministrationNASAL
Marketing Start Date2004-01-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameGlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Substance NameOXYMETAZOLINE HYDROCHLORIDE
Active Ingredient Strength1 mg/mL
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0573-1191-20

1 BOTTLE, SPRAY in 1 CARTON (0573-1191-20) > 15 mL in 1 BOTTLE, SPRAY
Marketing Start Date2004-01-01
Marketing End Date2021-06-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0573-1191-20 [00573119120]

DRISTAN 12 HR SPRAY
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2004-01-01

Drug Details

Active Ingredients

IngredientStrength
OXYMETAZOLINE HYDROCHLORIDE.5 mg/mL

OpenFDA Data

SPL SET ID:9ddfb021-fa96-94a6-a413-839ce5a7e744
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1000996
  • 1000990

    • NDC Crossover Matching brand name "DRISTAN 12 HR" or generic name "Oxymetazoline Hydrochloride"

    NDCBrand NameGeneric Name
    0573-1191DRISTAN 12 HRoxymetazoline hydrochloride
    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
    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
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