Home NDC 68788-7516 Oxymethazoline HCL
Product NDC 68788-7516
11-digit product format 687887516
Labeler code 68788
Product ID 68788-7516_e816f474-0a0b-4437-a451-e1c6e24b6d1e
Type HUMAN OTC DRUG
Nonproprietary name Oxymethazoline HCL
Dosage form SPRAY
Route NASAL
Labeler Preferred Pharmaceuticals Inc.
Application part341
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-02-11
Substance OXYMETAZOLINE HYDROCHLORIDE
Active strength .05 mg/1
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 Oxymethazoline HCL
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OXYMETAZOLINE HYDROCHLORIDE .05 mg/1
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 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 68788-7516-3 Oxymethazoline HCL 1 in 1 BOTTLE, SPRAY SPRAY 1 6 68788-7516-3 Oxymethazoline HCL 1 in 1 CARTON SPRAY 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68788-7516 OXYMETHAZOLINE HCL SPRAY [PREFERRED PHARMACEUTICALS INC.] 5 Current NDC, Legacy NDC, 2 package rows 20240724_cebf4a9c-b5c6-4ad8-ab7e-9bd3a80678c4.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 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 68788-7516-3 68788751603 1 BOTTLE, SPRAY in 1 CARTON (68788-7516-3) / 1 SPRAY in 1 BOTTLE, SPRAY 2020-02-11 0000-00-00 No No Current