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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70118-002IInactivated by FDA2026-10-12
excluded packagepackage70118-00270118-002-05IInactivated by FDA2026-10-12

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 dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70118-002-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70118-002-05IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70118-002-05IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70118-002-05IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70118-002-05IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70118-002-05IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70118-002-05IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70118-002-05IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70118-002-05IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70118-002-05IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70118-002-05IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70118-002-05IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage70118-002-05IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage70118-002-05IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage70118-002-05IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage70118-002-05IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage70118-002-05IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage70118-002-05IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage70118-002-05IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage70118-002-05IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage70118-002-05IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage70118-002-05EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70118-002-052020-01-31C16284748780-19d75b9d0-d6a2-f424-e053-dadaa90a57cePainKoolers Topical Analgesic Patch

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70118-002-05PainKoolers Topical Analgesic8 g in 1 PATCHGEL82
70118-002-05PainKoolers Topical Analgesic5 in 1 POUCHGEL52

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAPSAICINACTIVE INGREDIENTS07O44R1ZMPAINKOOLERS TOPICAL ANALGESIC (MENTHOL, UNSPECIFIED FORM, CAPSAICIN) GEL [GA HEALTH AND BEAUTY (FOSHAN) CO., LTD]2
MENTHOL, UNSPECIFIED FORMACTIVE INGREDIENTL7T10EIP3APAINKOOLERS TOPICAL ANALGESIC (MENTHOL, UNSPECIFIED FORM, CAPSAICIN) GEL [GA HEALTH AND BEAUTY (FOSHAN) CO., LTD]2
CAPSAICINACTIVE MOIETYS07O44R1ZMPAINKOOLERS TOPICAL ANALGESIC (MENTHOL, UNSPECIFIED FORM, CAPSAICIN) GEL [GA HEALTH AND BEAUTY (FOSHAN) CO., LTD]2
MENTHOLACTIVE MOIETYL7T10EIP3APAINKOOLERS TOPICAL ANALGESIC (MENTHOL, UNSPECIFIED FORM, CAPSAICIN) GEL [GA HEALTH AND BEAUTY (FOSHAN) CO., LTD]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XPAINKOOLERS TOPICAL ANALGESIC (MENTHOL, UNSPECIFIED FORM, CAPSAICIN) GEL [GA HEALTH AND BEAUTY (FOSHAN) CO., LTD]2
ARNICA MONTANAINACTIVE INGREDIENTO80TY208ZWPAINKOOLERS TOPICAL ANALGESIC (MENTHOL, UNSPECIFIED FORM, CAPSAICIN) GEL [GA HEALTH AND BEAUTY (FOSHAN) CO., LTD]2
DIHYDROXYALUMINUM AMINOACETATEINACTIVE INGREDIENTDO250MG0W6PAINKOOLERS TOPICAL ANALGESIC (MENTHOL, UNSPECIFIED FORM, CAPSAICIN) GEL [GA HEALTH AND BEAUTY (FOSHAN) CO., LTD]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPAINKOOLERS TOPICAL ANALGESIC (MENTHOL, UNSPECIFIED FORM, CAPSAICIN) GEL [GA HEALTH AND BEAUTY (FOSHAN) CO., LTD]2
KAOLININACTIVE INGREDIENT24H4NWX5COPAINKOOLERS TOPICAL ANALGESIC (MENTHOL, UNSPECIFIED FORM, CAPSAICIN) GEL [GA HEALTH AND BEAUTY (FOSHAN) CO., LTD]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPAINKOOLERS TOPICAL ANALGESIC (MENTHOL, UNSPECIFIED FORM, CAPSAICIN) GEL [GA HEALTH AND BEAUTY (FOSHAN) CO., LTD]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990PAINKOOLERS TOPICAL ANALGESIC (MENTHOL, UNSPECIFIED FORM, CAPSAICIN) GEL [GA HEALTH AND BEAUTY (FOSHAN) CO., LTD]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PAINKOOLERS TOPICAL ANALGESIC (MENTHOL, UNSPECIFIED FORM, CAPSAICIN) GEL [GA HEALTH AND BEAUTY (FOSHAN) CO., LTD]2
ROSEMARY OILINACTIVE INGREDIENT8LGU7VM393PAINKOOLERS TOPICAL ANALGESIC (MENTHOL, UNSPECIFIED FORM, CAPSAICIN) GEL [GA HEALTH AND BEAUTY (FOSHAN) CO., LTD]2
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XPAINKOOLERS TOPICAL ANALGESIC (MENTHOL, UNSPECIFIED FORM, CAPSAICIN) GEL [GA HEALTH AND BEAUTY (FOSHAN) CO., LTD]2
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HPAINKOOLERS TOPICAL ANALGESIC (MENTHOL, UNSPECIFIED FORM, CAPSAICIN) GEL [GA HEALTH AND BEAUTY (FOSHAN) CO., LTD]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAINKOOLERS TOPICAL ANALGESIC (MENTHOL, UNSPECIFIED FORM, CAPSAICIN) GEL [GA HEALTH AND BEAUTY (FOSHAN) CO., LTD]2
WATERINACTIVE INGREDIENT059QF0KO0RPAINKOOLERS 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
NDCDashboard titleSPL versionValidationDashboard ZIP
70118-002PAINKOOLERS TOPICAL ANALGESIC (MENTHOL, UNSPECIFIED FORM, CAPSAICIN) GEL [GA HEALTH AND BEAUTY (FOSHAN) CO., LTD]2Legacy NDC, 2 package rows20151130_d9e8b5c9-3c40-4917-ad56-5a38153ffa7e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
70118-002-05701180002058 g in 1 PATCH8 gHistorical