NDC 11527-140

12 Hour Original Nasal Decongestant

Nasal Spray

12 Hour Original Nasal Decongestant is a Nasal Liquid in the Human Otc Drug category. It is labeled and distributed by Sheffield Pharmaceuticals Llc. The primary component is Oxymetazoline Hydrochloride.

Product ID11527-140_15914b98-42cb-48af-b4ef-5ea78eb54c34
NDC11527-140
Product TypeHuman Otc Drug
Proprietary Name12 Hour Original Nasal Decongestant
Generic NameNasal Spray
Dosage FormLiquid
Route of AdministrationNASAL
Marketing Start Date2014-05-30
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameSheffield Pharmaceuticals LLC
Substance NameOXYMETAZOLINE HYDROCHLORIDE
Active Ingredient Strength50 mg/100mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 11527-140-55

1 BOTTLE, SPRAY in 1 CARTON (11527-140-55) > 30 mL in 1 BOTTLE, SPRAY
Marketing Start Date2014-05-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 11527-140-55 [11527014055]

12 Hour Original Nasal Decongestant LIQUID
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2014-05-30

Drug Details

Active Ingredients

IngredientStrength
OXYMETAZOLINE HYDROCHLORIDE50 mg/100mL

OpenFDA Data

SPL SET ID:cea0ce76-ae75-4484-a7c2-ff1086e9d8b0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1000990
  • NDC Crossover Matching brand name "12 Hour Original Nasal Decongestant" or generic name "Nasal Spray"

    NDCBrand NameGeneric Name
    11527-14012 Hour Original Nasal DecongestantNasal Spray
    67091-37812 Hour Original Nasal DecongestantNasal Spray
    67751-20912 Hour Original Nasal DecongestantNasal Spray
    68788-707512 Hour Original Nasal DecongestantNasal Spray
    67091-37712 Hour Nasal Decongestant Extra MoisturizingNasal Spray
    64616-039Olive Leaf NasalNasal Spray
    49997-356RhinoBlasterNasal Spray
    27017-018Xlear Nasal DecongestantNasal Spray

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