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NDC 11527-0140-55 12 Hour Original Nasal Decongestant 50 mg/100mL Details

12 Hour Original Nasal Decongestant 50 mg/100mL

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.

MedlinePlus Drug Summary

Oxymetazoline nasal spray is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Oxymetazoline nasal spray should not be used to treat children younger than 6 years of age unless it is recommended by a doctor. Children 6 to 12 years of age should use oxymetazoline nasal spray carefully and under adult supervision. Oxymetazoline is in a class of medications called nasal decongestants. It works by narrowing the blood vessels in the nasal passages.

Related Packages: 11527-0140-55
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Oxymetazoline Nasal Spray

Product Information

NDC	11527-0140
Product ID	11527-140_36eb3a35-be6c-4e5f-a189-2575f5dd142b
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	12 Hour Original Nasal Decongestant
Proprietary Name Suffix	n/a
Non-Proprietary Name	Nasal Spray
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	NASAL
Active Ingredient Strength	50
Active Ingredient Units	mg/100mL
Substance Name	OXYMETAZOLINE HYDROCHLORIDE
Labeler Name	Sheffield Pharmaceuticals LLC
Pharmaceutical Class	Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH DRUG
Application Number	M012
Listing Certified Through	2024-12-31

Package

NDC 11527-0140-55 (11527014055)

Pricing Information	N/A
NDC Package Code	11527-140-55
Billing NDC	11527014055
Package	1 BOTTLE, SPRAY in 1 CARTON (11527-140-55) / 30 mL in 1 BOTTLE, SPRAY
Marketing Start Date	2014-05-30
NDC Exclude Flag	N