Home NDC 55319-827 Family Wellness Oxymetazoline Sinus Severe
Product NDC 55319-827
11-digit product format 553190827
Labeler code 55319
Product ID 55319-827_5ec2de20-39db-93ea-e063-6294a90ac998
Type HUMAN OTC DRUG
Nonproprietary name Oxymetazoline
Dosage form SPRAY
Route NASAL
Labeler FAMILY DOLLAR (Family Wellness)
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-09-30
Marketing end 2028-03-02
Substance OXYMETAZOLINE HYDROCHLORIDE
Active strength 50 mg/100mL
Pharmacologic classes Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]
NDC exclude flag No
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 Family Wellness Oxymetazoline Sinus Severe Active Ingredients# Ingredient, Strength table Ingredient Strength OXYMETAZOLINE HYDROCHLORIDE 50 mg/100mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55319-827-30 Family Wellness Oxymetazoline Sinus Severe 30 mL in 1 BOTTLE SPRAY 30 3 55319-827-30 Family Wellness Oxymetazoline Sinus Severe 1 in 1 CARTON SPRAY 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55319-827 FAMILY WELLNESS OXYMETAZOLINE SINUS SEVERE (OXYMETAZOLINE) SPRAY [FAMILY DOLLAR (FAMILY WELLNESS)] 3 Current NDC, 2 package rows 20241122_13237d31-c60a-49f8-9b96-4414cf766a08.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 73 of 177 · 3,534 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55319-827-30 55319082730 1 BOTTLE in 1 CARTON (55319-827-30) / 30 mL in 1 BOTTLE 1 bottle 2023-09-30 2028-03-02 No No Historical