Home NDC 67510-0005-4 Muscle and Joint
Product NDC 67510-0005
Requested package NDC 67510-0005-4
11-digit product format 675100005
Labeler code 67510
Product ID 67510-0005_aa6b1714-7287-c388-e053-2995a90a9795
Type HUMAN OTC DRUG
Nonproprietary name Menthol
Dosage form GEL
Route TOPICAL
Labeler Kareway Product, Inc.
Application part348
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2011-08-11
Marketing end 0000-00-00
Substance MENTHOL
Active strength 3 g/100g
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record 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 · 8 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2020-06-10 20:45 UTC · source 2020-06-10 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Menthol ACTIVE INGREDIENT L7T10EIP3A MUSCLE AND JOINT (MENTHOL) GEL [KAREWAY PRODUCT, INC.] 1 Menthol ACTIVE MOIETY L7T10EIP3A MUSCLE AND JOINT (MENTHOL) GEL [KAREWAY PRODUCT, INC.] 1 CAMPHOR (SYNTHETIC) INACTIVE INGREDIENT 5TJD82A1ET MUSCLE AND JOINT (MENTHOL) GEL [KAREWAY PRODUCT, INC.] 1 CARBOMER HOMOPOLYMER TYPE C INACTIVE INGREDIENT 4Q93RCW27E MUSCLE AND JOINT (MENTHOL) GEL [KAREWAY PRODUCT, INC.] 1 glycerin INACTIVE INGREDIENT PDC6A3C0OX MUSCLE AND JOINT (MENTHOL) GEL [KAREWAY PRODUCT, INC.] 1 isopropyl alcohol INACTIVE INGREDIENT ND2M416302 MUSCLE AND JOINT (MENTHOL) GEL [KAREWAY PRODUCT, INC.] 1 methylparaben INACTIVE INGREDIENT A2I8C7HI9T MUSCLE AND JOINT (MENTHOL) GEL [KAREWAY PRODUCT, INC.] 1 polysorbate 60 INACTIVE INGREDIENT CAL22UVI4M MUSCLE AND JOINT (MENTHOL) GEL [KAREWAY PRODUCT, INC.] 1 trolamine INACTIVE INGREDIENT 9O3K93S3TK MUSCLE AND JOINT (MENTHOL) GEL [KAREWAY PRODUCT, INC.] 1 water INACTIVE INGREDIENT 059QF0KO0R MUSCLE AND JOINT (MENTHOL) GEL [KAREWAY PRODUCT, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67510-0005 MUSCLE AND JOINT (MENTHOL) GEL [KAREWAY PRODUCT, INC.] 5 Legacy NDC 20200715_0e46fc52-d4e8-48cc-8581-d78a0dd54064.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 67510-0005-4 67510000504 1 TUBE in 1 BOX (67510-0005-4) > 113 g in 1 TUBE 1 tube 2011-08-11 0000-00-00 No No Current