Home NDC 68071-3422 oxymetazoline hydrochloride
Product NDC 68071-3422
11-digit product format 680713422
Labeler code 68071
Product ID 68071-3422_36b1caf3-8f0e-088c-e063-6394a90a6a07
Type HUMAN OTC DRUG
Nonproprietary name oxymetazoline hydrochloride
Dosage form SPRAY
Route NASAL
Labeler NuCare Pharmaceuticals,Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2005-12-05
Marketing end 2027-02-28
Substance OXYMETAZOLINE HYDROCHLORIDE
Active strength .05 g/100mL
Pharmacologic classes Imidazolines [CS], Increased Sympathetic Activity [PE], Vasoconstriction [PE], Vasoconstrictor [EPC]
NDC exclude flag No
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 68071-3422-1 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 68071-3422-1 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 68071-3422-1 0efc9e666f02…f202fb6c5f17…
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 oxymetazoline hydrochloride Active Ingredients# Ingredient, Strength table Ingredient Strength OXYMETAZOLINE HYDROCHLORIDE .05 g/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 68071-3422-1 oxymetazoline hydrochloride 30 mL in 1 BOTTLE, SPRAY SPRAY 30 3 68071-3422-1 oxymetazoline hydrochloride 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 68071-3422 OXYMETAZOLINE HYDROCHLORIDE SPRAY [NUCARE PHARMACEUTICALS,INC.] 2 Current NDC, 2 package rows 20250306_fd058e2b-5445-e416-e053-6394a90a611b.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 74 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 Marketing end Sample Exclude flag Status 68071-3422-1 68071342201 1 BOTTLE, SPRAY in 1 CARTON (68071-3422-1) / 30 mL in 1 BOTTLE, SPRAY 2023-05-31 2027-02-28 No No Historical