MEDISTIK DUAL

Product NDC
50231-211
Requested package NDC
50231-211-11
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50231-21150231-211-11IInactivated by FDA2026-10-05

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 dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage50231-21150231-211-11EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…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 NDCProductDescriptionFormQuantityStrengthSPL version
50231-211-11MEDISTIK DUAL58 g in 1 CANISTERSTICK5814

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50231-211MEDISTIK DUAL (MENTHOL, METHYL SALICYLATE, EUCALUPTUS) STICK [NATURETEQ INC.]14Legacy NDC, 1 package rows20240103_9b7d94b4-7288-4f01-96ff-e8aa38053d71.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50231-211-115023102111158 g in 1 CANISTER (50231-211-11) 58 g2011-04-150000-00-00NoNoCurrent