FDA.reportPublic FDA data

Pain Relief Cream

Product NDC
58133-222
Requested package NDC
58133-222-03
11-digit product format
581330222
Labeler code
58133
Product ID
58133-222_798703c3-57e4-2723-e053-2a91aa0a4f58
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol 6%
Dosage form
CREAM
Route
TOPICAL
Labeler
Cosmetic Specialty labs, Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2018-10-31
Marketing end
0000-00-00
Substance
MENTHOL
Active strength
6 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 packagepackage58133-22258133-222-03IInactivated by FDA2026-10-05

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
58133-222-032024-01-30C16284748780-11030e365-6ab9-111a-e063-dadaa90a10e2Dr. Wolfe's OTC Energized Pain Relief Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58133-222-03Pain Relief CreamTopical Analgesic81 mL in 1 TUBECREAM811

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58133-222PAIN RELIEF CREAM TOPICAL ANALGESIC (MENTHOL 6%) CREAM [COSMETIC SPECIALTY LABS, INC.]1Legacy NDC, 1 package rows20181101_798703ab-16ba-6da3-e053-2991aa0a4688.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1488306menthol 6 % Topical CreamPSN798703ab-16ba-6da3-e053-2991aa0a46881
1488306menthol 60 MG/ML Topical CreamSCD798703ab-16ba-6da3-e053-2991aa0a46881
1488306menthol 6 % Topical CreamSY798703ab-16ba-6da3-e053-2991aa0a46881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58133-222-035813302220381 mL in 1 TUBE (58133-222-03) 81 ml2018-10-310000-00-00NoNoCurrent