Home NDC 11527-140 12 Hour Original Nasal Decongestant
Product NDC 11527-140
11-digit product format 115270140
Labeler code 11527
Product ID 11527-140_36eb3a35-be6c-4e5f-a189-2575f5dd142b
Type HUMAN OTC DRUG
Nonproprietary name Nasal Spray
Dosage form LIQUID
Route NASAL
Labeler Sheffield Pharmaceuticals LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-05-30
Substance OXYMETAZOLINE HYDROCHLORIDE
Active strength 50 mg/100mL
Pharmacologic classes Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base 12 Hour Original Nasal Decongestant
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXYMETAZOLINE HYDROCHLORIDE 50 mg/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination K89MJ0S5VY Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1000990 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 11527-140-55 12 Hour Original Nasal Decongestant 1 in 1 CARTON LIQUID 1 5 11527-140-55 12 Hour Original Nasal Decongestant 30 mL in 1 BOTTLE, SPRAY LIQUID 30 5
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11527-140 12 HOUR ORIGINAL NASAL DECONGESTANT (NASAL SPRAY) LIQUID [SHEFFIELD PHARMACEUTICALS LLC] 5 Current NDC, Legacy NDC, 2 package rows 20231031_cea0ce76-ae75-4484-a7c2-ff1086e9d8b0.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 151 of 177 · 3,534 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 11527-140-55 11527014055 1 BOTTLE, SPRAY in 1 CARTON (11527-140-55) / 30 mL in 1 BOTTLE, SPRAY 2014-05-30 0000-00-00 No No Current