TheraDerm

Product NDC
16903-169
11-digit product format
169030169
Labeler code
16903
Product ID
16903-169_65986bc2-c2f1-345e-e053-2991aa0ad094
Type
HUMAN OTC DRUG
Nonproprietary name
METHYL SALICYLATE 2-ETHYLBUTYRATE
Dosage form
SPRAY
Route
TOPICAL
Labeler
Manna Omni International Incorporated
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2017-03-17
Marketing end
0000-00-00
Substance
PEPPERMINT OIL; METHYL SALICYLATE 2-ETHYLBUTYRATE; MENTHOL; CAMPHOR OIL
Active strength
12 mg/120mg; mg/120mg; mg/120mg; mg/120mg
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
16903-169-022020-01-31C16284748780-19d75b9d0-ec83-f424-e053-dadaa90a57ceThera Derm Pain Relieving Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16903-169-02TheraDerm120 mg in 1 BOTTLESPRAY1203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16903-169THERADERM (METHYL SALICYLATE 2-ETHYLBUTYRATE) SPRAY [MANNA OMNI INTERNATIONAL INCORPORATED]3Legacy NDC, 1 package rows20180220_4ae05042-9d1b-69aa-e054-00144ff8d46c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
16903-169-0216903016902120 mg in 1 BOTTLE120 mgHistorical