PROTEC ROLL-ON

Product NDC
68678-067
11-digit product format
686780067
Labeler code
68678
Product ID
68678-067_0d617965-6c3a-431f-b4f9-43df13744f95
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
GEL
Route
TOPICAL
Labeler
ACH VENTURES CORP
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2016-02-19
Marketing end
0000-00-00
Substance
MENTHOL
Active strength
8 g/100mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
46e64ad7-7dca-4816-a2a4-8cdff2136105Product name220240828

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68678-067-042020-01-31C16284748780-19d75b9d0-311b-f424-e053-dadaa90a57cede81646b-748e-4cfd-93f1-a83abc91da42

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68678-067-04PROTEC ROLL-ON95 mL in 1 BOTTLE, DISPENSINGGEL952

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68678-067PROTEC ROLL-ON (MENTHOL) GEL [ACH VENTURES CORP]2Legacy NDC, 1 package rows20160225_de81646b-748e-4cfd-93f1-a83abc91da42.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283257menthol 8 % Topical GelPSNde81646b-748e-4cfd-93f1-a83abc91da422
283257menthol 0.08 MG/MG Topical GelSCDde81646b-748e-4cfd-93f1-a83abc91da422
283257menthol 8 % Topical GelSYde81646b-748e-4cfd-93f1-a83abc91da422

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
68678-067-046867800670495 mL in 1 BOTTLE, DISPENSING95 mlHistorical