Home NDC 70118-002 PainKoolers Topical Analgesic
Product NDC 70118-002
11-digit product format 701180002
Labeler code 70118
Product ID 70118-002_25c58c92-0362-0e8e-e054-00144ff8d46c
Type HUMAN OTC DRUG
Nonproprietary name MENTHOL, UNSPECIFIED FORM, CAPSAICIN
Dosage form GEL
Route TOPICAL
Labeler GA Health and Beauty (FOSHAN) Co., Ltd
Application part348
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2015-11-21
Marketing end 0000-00-00
Substance MENTHOL, UNSPECIFIED FORM; CAPSAICIN
Active strength 5 g/100g; g/100g
NDC exclude flag E
Listing certified through 2017-12-31
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 · 44 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 70118-002-05 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 70118-002-05 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 70118-002-05 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 70118-002-05 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 70118-002-05 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 70118-002-05 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 70118-002-05 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 70118-002-05 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 70118-002-05 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 70118-002-05 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 70118-002-05 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 70118-002-05 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 70118-002-05 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 70118-002-05 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 70118-002-05 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 70118-002-05 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 70118-002-05 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 70118-002-05 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 70118-002-05 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 70118-002-05 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 70118-002-05 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 70118-002-05 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 70118-002-05 PainKoolers Topical Analgesic 8 g in 1 PATCH GEL 8 2 70118-002-05 PainKoolers Topical Analgesic 5 in 1 POUCH GEL 5 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CAPSAICIN ACTIVE INGREDIENT S07O44R1ZM PAINKOOLERS TOPICAL ANALGESIC (MENTHOL, UNSPECIFIED FORM, CAPSAICIN) GEL [GA HEALTH AND BEAUTY (FOSHAN) CO., LTD] 2 MENTHOL, UNSPECIFIED FORM ACTIVE INGREDIENT L7T10EIP3A PAINKOOLERS TOPICAL ANALGESIC (MENTHOL, UNSPECIFIED FORM, CAPSAICIN) GEL [GA HEALTH AND BEAUTY (FOSHAN) CO., LTD] 2 CAPSAICIN ACTIVE MOIETY S07O44R1ZM PAINKOOLERS TOPICAL ANALGESIC (MENTHOL, UNSPECIFIED FORM, CAPSAICIN) GEL [GA HEALTH AND BEAUTY (FOSHAN) CO., LTD] 2 MENTHOL ACTIVE MOIETY L7T10EIP3A PAINKOOLERS TOPICAL ANALGESIC (MENTHOL, UNSPECIFIED FORM, CAPSAICIN) GEL [GA HEALTH AND BEAUTY (FOSHAN) CO., LTD] 2 ALOE VERA LEAF INACTIVE INGREDIENT ZY81Z83H0X PAINKOOLERS TOPICAL ANALGESIC (MENTHOL, UNSPECIFIED FORM, CAPSAICIN) GEL [GA HEALTH AND BEAUTY (FOSHAN) CO., LTD] 2 ARNICA MONTANA INACTIVE INGREDIENT O80TY208ZW PAINKOOLERS TOPICAL ANALGESIC (MENTHOL, UNSPECIFIED FORM, CAPSAICIN) GEL [GA HEALTH AND BEAUTY (FOSHAN) CO., LTD] 2 DIHYDROXYALUMINUM AMINOACETATE INACTIVE INGREDIENT DO250MG0W6 PAINKOOLERS TOPICAL ANALGESIC (MENTHOL, UNSPECIFIED FORM, CAPSAICIN) GEL [GA HEALTH AND BEAUTY (FOSHAN) CO., LTD] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX PAINKOOLERS TOPICAL ANALGESIC (MENTHOL, UNSPECIFIED FORM, CAPSAICIN) GEL [GA HEALTH AND BEAUTY (FOSHAN) CO., LTD] 2 KAOLIN INACTIVE INGREDIENT 24H4NWX5CO PAINKOOLERS TOPICAL ANALGESIC (MENTHOL, UNSPECIFIED FORM, CAPSAICIN) GEL [GA HEALTH AND BEAUTY (FOSHAN) CO., LTD] 2 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H PAINKOOLERS TOPICAL ANALGESIC (MENTHOL, UNSPECIFIED FORM, CAPSAICIN) GEL [GA HEALTH AND BEAUTY (FOSHAN) CO., LTD] 2 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 PAINKOOLERS TOPICAL ANALGESIC (MENTHOL, UNSPECIFIED FORM, CAPSAICIN) GEL [GA HEALTH AND BEAUTY (FOSHAN) CO., LTD] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 PAINKOOLERS TOPICAL ANALGESIC (MENTHOL, UNSPECIFIED FORM, CAPSAICIN) GEL [GA HEALTH AND BEAUTY (FOSHAN) CO., LTD] 2 ROSEMARY OIL INACTIVE INGREDIENT 8LGU7VM393 PAINKOOLERS TOPICAL ANALGESIC (MENTHOL, UNSPECIFIED FORM, CAPSAICIN) GEL [GA HEALTH AND BEAUTY (FOSHAN) CO., LTD] 2 SORBITAN MONOSTEARATE INACTIVE INGREDIENT NVZ4I0H58X PAINKOOLERS TOPICAL ANALGESIC (MENTHOL, UNSPECIFIED FORM, CAPSAICIN) GEL [GA HEALTH AND BEAUTY (FOSHAN) CO., LTD] 2 TARTARIC ACID INACTIVE INGREDIENT W4888I119H PAINKOOLERS TOPICAL ANALGESIC (MENTHOL, UNSPECIFIED FORM, CAPSAICIN) GEL [GA HEALTH AND BEAUTY (FOSHAN) CO., LTD] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP PAINKOOLERS TOPICAL ANALGESIC (MENTHOL, UNSPECIFIED FORM, CAPSAICIN) GEL [GA HEALTH AND BEAUTY (FOSHAN) CO., LTD] 2 WATER INACTIVE INGREDIENT 059QF0KO0R PAINKOOLERS TOPICAL ANALGESIC (MENTHOL, UNSPECIFIED FORM, CAPSAICIN) GEL [GA HEALTH AND BEAUTY (FOSHAN) CO., LTD] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70118-002 PAINKOOLERS TOPICAL ANALGESIC (MENTHOL, UNSPECIFIED FORM, CAPSAICIN) GEL [GA HEALTH AND BEAUTY (FOSHAN) CO., LTD] 2 Legacy NDC, 2 package rows 20151130_d9e8b5c9-3c40-4917-ad56-5a38153ffa7e.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 70118-002-05 70118000205 8 g in 1 PATCH 8 g Historical