Home NDC 65121-828-05 PainKoolers
Product NDC 65121-828
Requested package NDC 65121-828-05
11-digit product format 651210828
Labeler code 65121
Product ID 65121-828_d09a9c52-b3a8-2e30-e053-2995a90a4688
Type HUMAN OTC DRUG
Nonproprietary name MENTHOL, CAPSAICIN
Dosage form PATCH
Route TOPICAL
Labeler Pure Source, LLC
Application part348
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2014-12-30
Marketing end 0000-00-00
Substance MENTHOL; CAPSAICIN
Active strength 5 g/100g; g/100g
NDC exclude flag No
Listing certified through 2022-12-31
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 · 10 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…
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 CAPSAICIN ACTIVE INGREDIENT S07O44R1ZM PAINKOOLERS (MENTHOL, CAPSAICIN) PATCH [PURE SOURCE] 3 MENTHOL ACTIVE INGREDIENT L7T10EIP3A PAINKOOLERS (MENTHOL, CAPSAICIN) PATCH [PURE SOURCE] 3 CAPSAICIN ACTIVE MOIETY S07O44R1ZM PAINKOOLERS (MENTHOL, CAPSAICIN) PATCH [PURE SOURCE] 3 MENTHOL ACTIVE MOIETY L7T10EIP3A PAINKOOLERS (MENTHOL, CAPSAICIN) PATCH [PURE SOURCE] 3 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X PAINKOOLERS (MENTHOL, CAPSAICIN) PATCH [PURE SOURCE] 3 DIAZOLIDINYL UREA INACTIVE INGREDIENT H5RIZ3MPW4 PAINKOOLERS (MENTHOL, CAPSAICIN) PATCH [PURE SOURCE] 3 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K PAINKOOLERS (MENTHOL, CAPSAICIN) PATCH [PURE SOURCE] 3 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX PAINKOOLERS (MENTHOL, CAPSAICIN) PATCH [PURE SOURCE] 3 IODOPROPYNYL BUTYLCARBAMATE INACTIVE INGREDIENT 603P14DHEB PAINKOOLERS (MENTHOL, CAPSAICIN) PATCH [PURE SOURCE] 3 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T PAINKOOLERS (MENTHOL, CAPSAICIN) PATCH [PURE SOURCE] 3 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H PAINKOOLERS (MENTHOL, CAPSAICIN) PATCH [PURE SOURCE] 3 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH PAINKOOLERS (MENTHOL, CAPSAICIN) PATCH [PURE SOURCE] 3 WATER INACTIVE INGREDIENT 059QF0KO0R PAINKOOLERS (MENTHOL, CAPSAICIN) PATCH [PURE SOURCE] 3
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 65121-828-05 65121082805 5 PATCH in 1 BOX (65121-828-05) > 8 g in 1 PATCH 5 patch 2017-02-10 0000-00-00 No No Current