12 hour original nasal decongestant

Generic: nasal spray

Labeler: sheffield pharmaceuticals llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name 12 hour original nasal decongestant
Generic Name nasal spray
Labeler sheffield pharmaceuticals llc
Dosage Form LIQUID
Routes
NASAL
Active Ingredients

oxymetazoline hydrochloride 50 mg/100mL

Manufacturer
Sheffield Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 11527-140
Product ID 11527-140_36eb3a35-be6c-4e5f-a189-2575f5dd142b
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2014-05-30

Pharmacologic Class

Classes
imidazolines [cs] increased sympathetic activity [pe] vasoconstriction [pe] vasoconstrictor [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 11527140
Hyphenated Format 11527-140

Supplemental Identifiers

RxCUI
1000990
UNII
K89MJ0S5VY

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name 12 hour original nasal decongestant (source: ndc)
Generic Name nasal spray (source: ndc)
Application Number M012 (source: ndc)
Routes
NASAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/100mL
source: ndc
Packaging
  • 1 BOTTLE, SPRAY in 1 CARTON (11527-140-55) / 30 mL in 1 BOTTLE, SPRAY
source: ndc

Packages (1)

11527-140-55 1 BOTTLE, SPRAY in 1 CARTON (11527-140-55) / 30 mL in 1 BOTTLE, SPRAY

Ingredients (1)

oxymetazoline hydrochloride (50 mg/100mL)

Linked Drug Pages (1)

12 Hour Original Nasal Decongestant ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["NASAL"], "spl_id": "36eb3a35-be6c-4e5f-a189-2575f5dd142b", "openfda": {"unii": ["K89MJ0S5VY"], "rxcui": ["1000990"], "spl_set_id": ["cea0ce76-ae75-4484-a7c2-ff1086e9d8b0"], "manufacturer_name": ["Sheffield Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, SPRAY in 1 CARTON (11527-140-55)  / 30 mL in 1 BOTTLE, SPRAY", "package_ndc": "11527-140-55", "marketing_start_date": "20140530"}], "brand_name": "12 Hour Original Nasal Decongestant", "product_id": "11527-140_36eb3a35-be6c-4e5f-a189-2575f5dd142b", "dosage_form": "LIQUID", "pharm_class": ["Imidazolines [CS]", "Increased Sympathetic Activity [PE]", "Vasoconstriction [PE]", "Vasoconstrictor [EPC]"], "product_ndc": "11527-140", "generic_name": "Nasal Spray", "labeler_name": "Sheffield Pharmaceuticals LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "12 Hour Original Nasal Decongestant", "active_ingredients": [{"name": "OXYMETAZOLINE HYDROCHLORIDE", "strength": "50 mg/100mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20140530", "listing_expiration_date": "20261231"}