Home NDC 67510-0634 Muscle and Joint
Product NDC 67510-0634
11-digit product format 675100634
Labeler code 67510
Product ID 67510-0634_eda70b68-5c20-387b-e053-2a95a90ab5b2
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 2013-12-12
Marketing end 0000-00-00
Substance MENTHOL
Active strength 3 g/100g
NDC exclude flag No
Listing certified through 2023-12-31
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 · 18 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 67510-0634-4 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 67510-0634-4 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 67510-0634-4 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 67510-0634-4 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 67510-0634-4 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 67510-0634-4 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 67510-0634-4 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 67510-0634-4 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 67510-0634-4 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 67510-0634-4 Muscle and Joint 1 in 1 BOX GEL 1 6 67510-0634-4 Muscle and Joint 113 g in 1 TUBE GEL 113 6
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 67510-0634 MUSCLE AND JOINT (MENTHOL) GEL [KAREWAY PRODUCT, INC.] 6 Legacy NDC, 2 package rows 20221118_96f389d1-22e9-4744-bfbd-b55dd402ecae.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 67510-0634-4 67510063404 1 TUBE in 1 BOX (67510-0634-4) > 113 g in 1 TUBE 1 tube 2013-12-12 0000-00-00 No No Current