FDA.reportPublic FDA data

Road to Wellness

Product NDC
70983-017
Requested package NDC
70983-017-19
11-digit product format
709830017
Labeler code
70983
Product ID
70983-017_0cf78c45-128b-4144-a1a5-902c632a1d2e
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
KIT
Labeler
Saje Natural Business Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2016-10-16
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage70983-01770983-017-19IInactivated by FDA2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70983-017-19Road to Wellness1 in 1 KITKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70983-017ROAD TO WELLNESS (MENTHOL) KIT [SAJE NATURAL BUSINESS INC.]1Legacy NDC, 1 package rows20161025_d0bb6139-391e-4a44-bfe6-e065208c6843.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1813422menthol 1.27 % Topical OintmentPSNd0bb6139-391e-4a44-bfe6-e065208c68431
1813422menthol 0.0127 MG/MG Topical OintmentSCDd0bb6139-391e-4a44-bfe6-e065208c68431
1813422menthol 1.27 % Topical OintmentSYd0bb6139-391e-4a44-bfe6-e065208c68431

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70983-017-19709830017191 KIT in 1 KIT (70983-017-19) * 6 mL in 1 BOTTLE, DROPPER * 6 mL in 1 BOTTLE, DROPPER * 13.5 g in 1 CANISTER1 kit2016-10-160000-00-00NoNoCurrent