FDA.reportPublic FDA data

BIOTEMPER

Product NDC
71718-333
11-digit product format
717180333
Labeler code
71718
Product ID
71718-333_158b958a-1a99-4f82-931b-c5c83e320ad2
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
GEL
Route
TOPICAL
Labeler
Scientific Solutions Global, LLC
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2017-09-01
Marketing end
0000-00-00
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
10 g/100mL
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
71718-333-012020-01-31C16284748780-19d75b9d0-68f5-f424-e053-dadaa90a57ceBIOTEMPER
71718-333-022020-01-31C16284748780-19d75b9d0-68f5-f424-e053-dadaa90a57ceBIOTEMPER
71718-333-042020-01-31C16284748780-19d75b9d0-68f5-f424-e053-dadaa90a57ceBIOTEMPER
71718-333-052020-01-31C16284748780-19d75b9d0-68f5-f424-e053-dadaa90a57ceBIOTEMPER
71718-333-072020-01-31C16284748780-19d75b9d0-68f5-f424-e053-dadaa90a57ceBIOTEMPER
71718-333-092020-01-31C16284748780-19d75b9d0-68f5-f424-e053-dadaa90a57ceBIOTEMPER
71718-333-112020-01-31C16284748780-19d75b9d0-68f5-f424-e053-dadaa90a57ceBIOTEMPER
71718-333-132020-01-31C16284748780-19d75b9d0-68f5-f424-e053-dadaa90a57ceBIOTEMPER
71718-333-152020-01-31C16284748780-19d75b9d0-68f5-f424-e053-dadaa90a57ceBIOTEMPER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71718-333-01BIOTEMPER118 mL in 1 JARGEL1181
71718-333-02BIOTEMPER2 in 1 PACKAGEGEL21
71718-333-02BIOTEMPER118 mL in 1 JARGEL1181
71718-333-04BIOTEMPER118 mL in 1 TUBEGEL1181
71718-333-05BIOTEMPER2 in 1 PACKAGEGEL21
71718-333-05BIOTEMPER118 mL in 1 TUBEGEL1181
71718-333-07BIOTEMPER237 mL in 1 BOTTLE, PUMPGEL2371
71718-333-09BIOTEMPER452 mL in 1 BOTTLE, PUMPGEL4521
71718-333-11BIOTEMPER946 mL in 1 BOTTLE, PUMPGEL9461
71718-333-13BIOTEMPER1893 mL in 1 BOTTLE, PUMPGEL18931
71718-333-15BIOTEMPER3785 mL in 1 BOTTLE, PUMPGEL37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71718-333BIOTEMPER (MENTHOL) GEL [SCIENTIFIC SOLUTIONS GLOBAL, LLC]1Legacy NDC, 11 package rows20180213_667fb0b9-6095-4c6c-8731-a4f888951ecc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259249menthol 10 % Topical GelPSN667fb0b9-6095-4c6c-8731-a4f888951ecc1
259249menthol 0.1 MG/MG Topical GelSCD667fb0b9-6095-4c6c-8731-a4f888951ecc1
259249menthol 10 % Topical GelSY667fb0b9-6095-4c6c-8731-a4f888951ecc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
71718-333-0171718033301118 mL in 1 JAR118 mlHistorical
71718-333-02717180333022 in 1 PACKAGEHistorical
71718-333-0471718033304118 mL in 1 TUBE118 mlHistorical
71718-333-05717180333052 in 1 PACKAGEHistorical
71718-333-0771718033307237 mL in 1 BOTTLE, PUMP237 mlHistorical
71718-333-0971718033309452 mL in 1 BOTTLE, PUMP452 mlHistorical
71718-333-1171718033311946 mL in 1 BOTTLE, PUMP946 mlHistorical
71718-333-13717180333131893 mL in 1 BOTTLE, PUMP1893 mlHistorical
71718-333-15717180333153785 mL in 1 BOTTLE, PUMP3785 mlHistorical