TopiCool Pain Relief

Product NDC
57698-100
Requested package NDC
57698-100-04
11-digit product format
576980100
Labeler code
57698
Product ID
57698-100_6ee1a4cb-7b12-45a8-b78d-572771d5aa86
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
GEL
Route
TOPICAL
Labeler
TENSproducts, Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-08-01
Marketing end
0000-00-00
Substance
MENTHOL, UNSPECIFIED FORM; CAMPHOR (NATURAL)
Active strength
5 g/100g; g/100g
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage57698-10057698-100-04IInactivated by FDA2026-10-05

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 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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 NDCProductDescriptionFormQuantityStrengthSPL version
57698-100-03TopiCool Pain Reliefwith Cats Claw85.049 g in 1 TUBEGEL85.0492
57698-100-04TopiCool Pain Reliefwith Cats Claw113.4 g in 1 TUBEGEL113.42

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAMPHOR (NATURAL)ACTIVE INGREDIENTN20HL7Q941TOPICOOL PAIN RELIEF WITH CATS CLAW (MENTHOL) GEL [TENSPRODUCTS, INC.]1
CAMPHOR (NATURAL)ACTIVE INGREDIENTN20HL7Q941TOPICOOL PAIN RELIEF WITH CATS CLAW (MENTHOL) GEL [TENSPRODUCTS, INC.]1
MENTHOLACTIVE INGREDIENTL7T10EIP3ATOPICOOL PAIN RELIEF WITH CATS CLAW (MENTHOL) GEL [TENSPRODUCTS, INC.]1
MENTHOLACTIVE INGREDIENTL7T10EIP3ATOPICOOL PAIN RELIEF WITH CATS CLAW (MENTHOL) GEL [TENSPRODUCTS, INC.]1
CAMPHOR (NATURAL)ACTIVE MOIETYN20HL7Q941TOPICOOL PAIN RELIEF WITH CATS CLAW (MENTHOL) GEL [TENSPRODUCTS, INC.]1
CAMPHOR (NATURAL)ACTIVE MOIETYN20HL7Q941TOPICOOL PAIN RELIEF WITH CATS CLAW (MENTHOL) GEL [TENSPRODUCTS, INC.]1
MENTHOLACTIVE MOIETYL7T10EIP3ATOPICOOL PAIN RELIEF WITH CATS CLAW (MENTHOL) GEL [TENSPRODUCTS, INC.]1
MENTHOLACTIVE MOIETYL7T10EIP3ATOPICOOL PAIN RELIEF WITH CATS CLAW (MENTHOL) GEL [TENSPRODUCTS, INC.]1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUTOPICOOL PAIN RELIEF WITH CATS CLAW (MENTHOL) GEL [TENSPRODUCTS, INC.]1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUTOPICOOL PAIN RELIEF WITH CATS CLAW (MENTHOL) GEL [TENSPRODUCTS, INC.]1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PTOPICOOL PAIN RELIEF WITH CATS CLAW (MENTHOL) GEL [TENSPRODUCTS, INC.]1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PTOPICOOL PAIN RELIEF WITH CATS CLAW (MENTHOL) GEL [TENSPRODUCTS, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTOPICOOL PAIN RELIEF WITH CATS CLAW (MENTHOL) GEL [TENSPRODUCTS, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTOPICOOL PAIN RELIEF WITH CATS CLAW (MENTHOL) GEL [TENSPRODUCTS, INC.]1
ILEX PARAGUARIENSIS LEAFINACTIVE INGREDIENT1Q953B4O4FTOPICOOL PAIN RELIEF WITH CATS CLAW (MENTHOL) GEL [TENSPRODUCTS, INC.]1
ILEX PARAGUARIENSIS LEAFINACTIVE INGREDIENT1Q953B4O4FTOPICOOL PAIN RELIEF WITH CATS CLAW (MENTHOL) GEL [TENSPRODUCTS, INC.]1
INDIAN FRANKINCENSEINACTIVE INGREDIENT4PW41QCO2MTOPICOOL PAIN RELIEF WITH CATS CLAW (MENTHOL) GEL [TENSPRODUCTS, INC.]1
INDIAN FRANKINCENSEINACTIVE INGREDIENT4PW41QCO2MTOPICOOL PAIN RELIEF WITH CATS CLAW (MENTHOL) GEL [TENSPRODUCTS, INC.]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302TOPICOOL PAIN RELIEF WITH CATS CLAW (MENTHOL) GEL [TENSPRODUCTS, INC.]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302TOPICOOL PAIN RELIEF WITH CATS CLAW (MENTHOL) GEL [TENSPRODUCTS, INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TTOPICOOL PAIN RELIEF WITH CATS CLAW (MENTHOL) GEL [TENSPRODUCTS, INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TTOPICOOL PAIN RELIEF WITH CATS CLAW (MENTHOL) GEL [TENSPRODUCTS, INC.]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHTOPICOOL PAIN RELIEF WITH CATS CLAW (MENTHOL) GEL [TENSPRODUCTS, INC.]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHTOPICOOL PAIN RELIEF WITH CATS CLAW (MENTHOL) GEL [TENSPRODUCTS, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TOPICOOL PAIN RELIEF WITH CATS CLAW (MENTHOL) GEL [TENSPRODUCTS, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TOPICOOL PAIN RELIEF WITH CATS CLAW (MENTHOL) GEL [TENSPRODUCTS, INC.]1
TRIMETHYLOLPROPANEINACTIVE INGREDIENT090GDF4HBDTOPICOOL PAIN RELIEF WITH CATS CLAW (MENTHOL) GEL [TENSPRODUCTS, INC.]1
TRIMETHYLOLPROPANEINACTIVE INGREDIENT090GDF4HBDTOPICOOL PAIN RELIEF WITH CATS CLAW (MENTHOL) GEL [TENSPRODUCTS, INC.]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKTOPICOOL PAIN RELIEF WITH CATS CLAW (MENTHOL) GEL [TENSPRODUCTS, INC.]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKTOPICOOL PAIN RELIEF WITH CATS CLAW (MENTHOL) GEL [TENSPRODUCTS, INC.]1
UNCARIA TOMENTOSA ROOTINACTIVE INGREDIENT9IGG929A0HTOPICOOL PAIN RELIEF WITH CATS CLAW (MENTHOL) GEL [TENSPRODUCTS, INC.]1
UNCARIA TOMENTOSA ROOTINACTIVE INGREDIENT9IGG929A0HTOPICOOL PAIN RELIEF WITH CATS CLAW (MENTHOL) GEL [TENSPRODUCTS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RTOPICOOL PAIN RELIEF WITH CATS CLAW (MENTHOL) GEL [TENSPRODUCTS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RTOPICOOL PAIN RELIEF WITH CATS CLAW (MENTHOL) GEL [TENSPRODUCTS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57698-100TOPICOOL PAIN RELIEF WITH CATS CLAW (MENTHOL) GEL [TENSPRODUCTS, INC.]2Legacy NDC, 1 package rows20181103_7204f07b-f4cc-4ec6-a57f-122ed25987ec.zip
57698-100TOPICOOL PAIN RELIEF WITH CATS CLAW (MENTHOL) GEL [TENSPRODUCTS, INC.]2Legacy NDC, 1 package rows20181103_dea61545-a523-417c-9df8-f494c279e4ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1435269camphor 0.4 % / menthol 4.5 % Topical GelPSN7204f07b-f4cc-4ec6-a57f-122ed25987ec2
1435269camphor 0.4 % / menthol 4.5 % Topical GelPSNdea61545-a523-417c-9df8-f494c279e4ae2
1435274TopiCool 0.4 % / 4.5 % Topical GelPSN7204f07b-f4cc-4ec6-a57f-122ed25987ec2
1435274TopiCool 0.4 % / 4.5 % Topical GelPSNdea61545-a523-417c-9df8-f494c279e4ae2
1435274camphor 0.004 MG/MG / menthol 0.045 MG/MG Topical Gel [TopiCool]SBD7204f07b-f4cc-4ec6-a57f-122ed25987ec2
1435274camphor 0.004 MG/MG / menthol 0.045 MG/MG Topical Gel [TopiCool]SBDdea61545-a523-417c-9df8-f494c279e4ae2
1435269camphor 0.004 MG/MG / menthol 0.045 MG/MG Topical GelSCD7204f07b-f4cc-4ec6-a57f-122ed25987ec2
1435269camphor 0.004 MG/MG / menthol 0.045 MG/MG Topical GelSCDdea61545-a523-417c-9df8-f494c279e4ae2
1435269camphor 0.4 % / menthol 4.5 % Topical GelSY7204f07b-f4cc-4ec6-a57f-122ed25987ec2
1435269camphor 0.4 % / menthol 4.5 % Topical GelSYdea61545-a523-417c-9df8-f494c279e4ae2
1435274TopiCool (camphor 0.4 % / menthol 4.5 % ) Topical GelSY7204f07b-f4cc-4ec6-a57f-122ed25987ec2
1435274TopiCool (camphor 0.4 % / menthol 4.5 % ) Topical GelSYdea61545-a523-417c-9df8-f494c279e4ae2
1435274TopiCool Pain Relief (camphor 0.004 MG/MG / menthol 0.045 MG/MG) Topical GelSY7204f07b-f4cc-4ec6-a57f-122ed25987ec2
1435274TopiCool Pain Relief (camphor 0.004 MG/MG / menthol 0.045 MG/MG) Topical GelSYdea61545-a523-417c-9df8-f494c279e4ae2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57698-100-0457698010004113.4 g in 1 TUBE (57698-100-04) 113.4 g2013-08-010000-00-00NoNoCurrent