BIOCOOL

Product NDC
70612-010
Requested package NDC
70612-010-02
11-digit product format
706120010
Labeler code
70612
Product ID
70612-010_3a3614d6-ca20-4556-b768-6e1598e6aa0b
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
GEL
Route
TOPICAL
Labeler
JJindustry.Co.Ltd
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2016-03-02
Marketing end
0000-00-00
Substance
MENTHOL
Active strength
4 g/100mL
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 packagepackage70612-01070612-010-02IInactivated by FDA2026-10-16

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
70612-010-01BIOCOOLTube Type100 mL in 1 TUBEGEL1001
70612-010-02BIOCOOLTube Type1 in 1 CARTONGEL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70612-010BIOCOOL TUBE TYPE (MENTHOL) GEL [JJINDUSTRY.CO.LTD]1Legacy NDC, 2 package rows20160419_dd430130-eb92-47fc-a113-a1a90d169810.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
415974menthol 4 % Topical GelPSNdd430130-eb92-47fc-a113-a1a90d1698101
415974menthol 0.04 MG/MG Topical GelSCDdd430130-eb92-47fc-a113-a1a90d1698101
415974menthol 4 % Topical GelSYdd430130-eb92-47fc-a113-a1a90d1698101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70612-010-02706120010021 TUBE in 1 CARTON (70612-010-02) > 100 mL in 1 TUBE (70612-010-01) 1 tube2016-03-020000-00-00NoNoCurrent