Biotemper

Product NDC
81376-001
11-digit product format
813760001
Labeler code
81376
Product ID
81376-001_c0808c11-50ad-6536-e053-2995a90a886f
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
GEL
Route
TOPICAL
Labeler
SSG Ventures Inc
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2021-01-01
Marketing end
0000-00-00
Substance
MENTHOL
Active strength
1 g/10mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81376-001-01Biotemper113 mL in 1 JARGEL1131
81376-001-02Biotemper452 mL in 1 BOTTLE, PUMPGEL4521
81376-001-03Biotemper1900 mL in 1 BOTTLE, PUMPGEL19001
81376-001-04Biotemper89 mL in 1 TUBE, WITH APPLICATORGEL891
81376-001-05Biotemper118 mL in 1 BOTTLE, SPRAYGEL1181
81376-001-06Biotemper118 mL in 1 TUBEGEL1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81376-001BIOTEMPER (MENTHOL) GEL BIOTEMPER FOOT CREAM (MENTHOL) GEL [SSG VENTURES INC]1Legacy NDC, 6 package rows20210422_c0808c11-50ac-6536-e053-2995a90a886f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259249menthol 10 % Topical GelPSNc0808c11-50ac-6536-e053-2995a90a886f1
259249menthol 0.1 MG/MG Topical GelSCDc0808c11-50ac-6536-e053-2995a90a886f1
259249menthol 10 % Topical GelSYc0808c11-50ac-6536-e053-2995a90a886f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81376-001-0181376000101113 mL in 1 JAR (81376-001-01) 113 ml2021-01-010000-00-00NoNoCurrent
81376-001-0281376000102452 mL in 1 BOTTLE, PUMP (81376-001-02) 452 ml2021-01-010000-00-00NoNoCurrent
81376-001-03813760001031900 mL in 1 BOTTLE, PUMP (81376-001-03) 1900 ml2021-01-010000-00-00NoNoCurrent
81376-001-048137600010489 mL in 1 TUBE, WITH APPLICATOR (81376-001-04) 89 ml2021-01-010000-00-00NoNoCurrent
81376-001-0581376000105118 mL in 1 BOTTLE, SPRAY (81376-001-05) 118 ml2021-01-010000-00-00NoNoCurrent
81376-001-0681376000106118 mL in 1 TUBE (81376-001-06) 118 ml2021-01-010000-00-00NoNoCurrent