Home NDC 70000-0001-1 leader nasal
Product NDC 70000-0001
Requested package NDC 70000-0001-1
11-digit product format 700000001
Labeler code 70000
Product ID 70000-0001_f320e8fc-c536-403d-ac55-ea0ce6c767ab
Type HUMAN OTC DRUG
Nonproprietary name Oxymetazoline Hydrochloride
Dosage form SPRAY
Route NASAL
Labeler Cardinal Health 110, LLC. dba Leader
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2020-01-14
Marketing end 0000-00-00
Substance OXYMETAZOLINE HYDROCHLORIDE
Active strength 0 g/100mL
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record 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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 70000-0001 70000-0001-1 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70000-0001 LEADER NASAL (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [CARDINAL HEALTH 110, LLC. DBA LEADER] 3 Legacy NDC 20240829_3e77b550-edd6-4027-a63f-5a05d46bb69a.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70000-0001-1 70000000101 1 BOTTLE in 1 CARTON (70000-0001-1) > 30 mL in 1 BOTTLE 1 bottle 2020-01-14 0000-00-00 No No Current