FDA.reportPublic FDA data

JACK BLACK PERFORMANCE REMEDY DRAGON ICE

Product NDC
66738-101
Requested package NDC
66738-101-11
11-digit product format
667380101
Labeler code
66738
Product ID
66738-101_d4b682c6-7465-3990-e053-2995a90aeb3f
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
CREAM
Route
TOPICAL
Labeler
JACK BLACK LLC
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2019-07-13
Marketing end
0000-00-00
Substance
MENTHOL
Active strength
2 g/100g
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage66738-10166738-101-11IInactivated by FDA2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66738-101-112025-01-30C16284748780-12cef2736-b660-d83d-e063-dadaa90ab31fJACK BLACK - PERFORMANCE REMEDY DRAGON ICE (66738-101)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66738-101-11JACK BLACK PERFORMANCE REMEDY DRAGON ICE113 g in 1 TUBECREAM1133

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66738-101JACK BLACK PERFORMANCE REMEDY DRAGON ICE (MENTHOL) CREAM [JACK BLACK LLC]3Legacy NDC, 1 package rows20220104_2db748ee-519f-42d5-aac1-d2737d57fc93.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2178768menthol 2.2 % Topical CreamPSN2db748ee-519f-42d5-aac1-d2737d57fc933
2178768menthol 22 MG/ML Topical CreamSCD2db748ee-519f-42d5-aac1-d2737d57fc933
2178768menthol 2.2 % Topical CreamSY2db748ee-519f-42d5-aac1-d2737d57fc933

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66738-101-1166738010111113 g in 1 TUBE (66738-101-11) 113 g2019-07-130000-00-00NoNoCurrent