Comfort and Ease

Product NDC
70983-016
Requested package NDC
70983-016-18
11-digit product format
709830016
Labeler code
70983
Product ID
70983-016_0d5fdd1a-36c8-4103-89b3-0db0b55c9bb3
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
KIT
Labeler
Saje Natural Business Inc.
Application
part341
Marketing category
OTC MONOGRAPH 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 packagepackage70983-01670983-016-18IInactivated by FDA2026-10-12

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
70983-016-18Comfort and Ease1 in 1 KITKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70983-016COMFORT AND EASE (MENTHOL) KIT [SAJE NATURAL BUSINESS INC.]1Legacy NDC, 1 package rows20161025_97640f0c-0e8d-48ad-80a2-d3988962ded2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70983-016-18709830016181 KIT in 1 KIT (70983-016-18) * 6 mL in 1 BOTTLE, DROPPER * 6 mL in 1 BOTTLE, DROPPER * 6 mL in 1 BOTTLE, DROPPER1 kit2016-10-160000-00-00NoNoCurrent