Home NDC 0067-0109 Theraflu
Product NDC 0067-0109
11-digit product format 000670109
Labeler code 0067
Product ID 0067-0109_53c5434b-3e1e-475f-e063-6394a90a7d25
Type HUMAN OTC DRUG
Nonproprietary name Oxymetazoline HCl
Dosage form SPRAY
Route NASAL
Labeler Haleon US Holdings LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-06-01
Substance OXYMETAZOLINE HYDROCHLORIDE
Active strength .5 mg/mL
Pharmacologic classes Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 Theraflu
Brand name suffix Severe Congestion Relief Cooling Nasal Mist
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXYMETAZOLINE HYDROCHLORIDE .5 mg/mL
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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0067-0109-01 TherafluSevere Congestion Relief Cooling Nasal Mist 10 mL in 1 BOTTLE, SPRAY SPRAY 10 2 0067-0109-01 TherafluSevere Congestion Relief Cooling Nasal Mist 1 in 1 CARTON SPRAY 1 2
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 98 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0067-0109-01 00067010901 1 BOTTLE, SPRAY in 1 CARTON (0067-0109-01) / 10 mL in 1 BOTTLE, SPRAY 2025-06-01 No No Current