Home NDC 64058-118 Pure Relief
Product NDC 64058-118
11-digit product format 640580118
Labeler code 64058
Product ID 64058-118_4e46efaf-2928-410f-bf14-31517a6cea19
Type HUMAN OTC DRUG
Nonproprietary name Capsaicin
Dosage form GEL
Route TOPICAL
Labeler Concept Laboratories, Inc.
Application part348
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2013-12-06
Marketing end 0000-00-00
Substance CAPSAICIN
Active strength 0 g/118mL
NDC exclude flag No
Listing certified through 2019-12-31
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 · 42 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 64058-118-14 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 64058-118-14 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 64058-118-14 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 64058-118-14 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 64058-118-14 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 64058-118-14 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 64058-118-14 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 64058-118-14 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 64058-118-14 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 64058-118-14 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 64058-118-14 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 64058-118-14 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 64058-118-14 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 64058-118-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 64058-118-14 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 64058-118-14 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 64058-118-14 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 64058-118-14 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 64058-118-14 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 64058-118-14 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 64058-118-14 9bebd1f3094a…5416666fcb17…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 64058-118-14 Pure Relief Penetrating Pain Relief 118 mL in 1 BOTTLE GEL 118 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Capsaicin ACTIVE INGREDIENT S07O44R1ZM PURE RELIEF PENETRATING PAIN RELIEF (CAPSAICIN) GEL [CONCEPT LABORATORIES, INC.] 1 Capsaicin ACTIVE MOIETY S07O44R1ZM PURE RELIEF PENETRATING PAIN RELIEF (CAPSAICIN) GEL [CONCEPT LABORATORIES, INC.] 1 .ALPHA.-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 PURE RELIEF PENETRATING PAIN RELIEF (CAPSAICIN) GEL [CONCEPT LABORATORIES, INC.] 1 ALFALFA LEAF INACTIVE INGREDIENT HY3L927V6M PURE RELIEF PENETRATING PAIN RELIEF (CAPSAICIN) GEL [CONCEPT LABORATORIES, INC.] 1 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X PURE RELIEF PENETRATING PAIN RELIEF (CAPSAICIN) GEL [CONCEPT LABORATORIES, INC.] 1 ASIAN GINSENG INACTIVE INGREDIENT CUQ3A77YXI PURE RELIEF PENETRATING PAIN RELIEF (CAPSAICIN) GEL [CONCEPT LABORATORIES, INC.] 1 CYMBOPOGON SCHOENANTHUS LEAF INACTIVE INGREDIENT XF54B1Z2HF PURE RELIEF PENETRATING PAIN RELIEF (CAPSAICIN) GEL [CONCEPT LABORATORIES, INC.] 1 DIMETHYL SULFONE INACTIVE INGREDIENT 9H4PO4Z4FT PURE RELIEF PENETRATING PAIN RELIEF (CAPSAICIN) GEL [CONCEPT LABORATORIES, INC.] 1 DMDM HYDANTOIN INACTIVE INGREDIENT BYR0546TOW PURE RELIEF PENETRATING PAIN RELIEF (CAPSAICIN) GEL [CONCEPT LABORATORIES, INC.] 1 EMU OIL INACTIVE INGREDIENT 344821WD61 PURE RELIEF PENETRATING PAIN RELIEF (CAPSAICIN) GEL [CONCEPT LABORATORIES, INC.] 1 GINKGO INACTIVE INGREDIENT 19FUJ2C58T PURE RELIEF PENETRATING PAIN RELIEF (CAPSAICIN) GEL [CONCEPT LABORATORIES, INC.] 1 GLUCOSAMINE HYDROCHLORIDE INACTIVE INGREDIENT 750W5330FY PURE RELIEF PENETRATING PAIN RELIEF (CAPSAICIN) GEL [CONCEPT LABORATORIES, INC.] 1 Glycerin INACTIVE INGREDIENT PDC6A3C0OX PURE RELIEF PENETRATING PAIN RELIEF (CAPSAICIN) GEL [CONCEPT LABORATORIES, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T PURE RELIEF PENETRATING PAIN RELIEF (CAPSAICIN) GEL [CONCEPT LABORATORIES, INC.] 1 PEG-75 LANOLIN INACTIVE INGREDIENT 09179OX7TB PURE RELIEF PENETRATING PAIN RELIEF (CAPSAICIN) GEL [CONCEPT LABORATORIES, INC.] 1 POLYSORBATE 20 INACTIVE INGREDIENT 7T1F30V5YH PURE RELIEF PENETRATING PAIN RELIEF (CAPSAICIN) GEL [CONCEPT LABORATORIES, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 PURE RELIEF PENETRATING PAIN RELIEF (CAPSAICIN) GEL [CONCEPT LABORATORIES, INC.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH PURE RELIEF PENETRATING PAIN RELIEF (CAPSAICIN) GEL [CONCEPT LABORATORIES, INC.] 1 TROLAMINE INACTIVE INGREDIENT 9O3K93S3TK PURE RELIEF PENETRATING PAIN RELIEF (CAPSAICIN) GEL [CONCEPT LABORATORIES, INC.] 1 Water INACTIVE INGREDIENT 059QF0KO0R PURE RELIEF PENETRATING PAIN RELIEF (CAPSAICIN) GEL [CONCEPT LABORATORIES, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64058-118 PURE RELIEF PENETRATING PAIN RELIEF (CAPSAICIN) GEL [CONCEPT LABORATORIES, INC.] 1 Legacy NDC, 1 package rows 20140215_d71b0793-0e69-4249-ac4b-d819fe2882aa.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 64058-118-14 64058011814 118 mL in 1 BOTTLE 118 ml Historical