Home NDC 50231-211 MEDISTIK DUAL
Product NDC 50231-211
11-digit product format 502310211
Labeler code 50231
Product ID 50231-211_ec20e1b9-994c-817c-e053-2a95a90a1370
Type HUMAN OTC DRUG
Nonproprietary name MENTHOL, METHYL SALICYLATE, EUCALUPTUS
Dosage form STICK
Route TOPICAL
Labeler Natureteq Inc.
Application part348
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2011-04-15
Marketing end 0000-00-00
Substance EUCALYPTUS GLOBULUS LEAF; MENTHOL; METHYL SALICYLATE
Active strength 1 g/100g; g/100g; g/100g
NDC exclude flag No
Listing certified through 2023-12-31
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 · 2 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 2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 50231-211 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 50231-211 50231-211-11 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50231-211-11 MEDISTIK DUAL 58 g in 1 CANISTER STICK 58 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50231-211 MEDISTIK DUAL (MENTHOL, METHYL SALICYLATE, EUCALUPTUS) STICK [NATURETEQ INC.] 14 Legacy NDC, 1 package rows 20240103_9b7d94b4-7288-4f01-96ff-e8aa38053d71.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50231-211-11 50231021111 58 g in 1 CANISTER (50231-211-11) 58 g 2011-04-15 0000-00-00 No No Current