SORE NO MORE COOL THERAPY

Product NDC
61577-3235
11-digit product format
615773235
Labeler code
61577
Product ID
61577-3235_3622f4f5-48bf-9035-e063-6294a90afac2
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
GEL
Route
TOPICAL
Labeler
SOMBRA COSMETICS INC.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-06-14
Substance
MENTHOL
Active strength
.06 g/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 2 · 72 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61577-3235-6IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61577-3235-7IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61577-3235-4IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61577-3235-9IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61577-3235-1IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61577-3235-5IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61577-3235-2IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61577-3235-8IInactivated 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 packagepackage61577-3235-6IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61577-3235-7IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61577-3235-4IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61577-3235-9IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61577-3235-1IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61577-3235-5IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61577-3235-2IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61577-3235-8IInactivated 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 packagepackage61577-3235-6IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61577-3235-7IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61577-3235-4IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61577-3235-9IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61577-3235-1IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61577-3235-5IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61577-3235-2IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61577-3235-8IInactivated 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 packagepackage61577-3235-6IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61577-3235-7IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61577-3235-4IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61577-3235-9IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61577-3235-1IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61577-3235-5IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61577-3235-2IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61577-3235-8IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61577-3235-5UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61577-3235-7UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61577-3235-6UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61577-3235-2UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61577-3235-8UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61577-3235-9UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61577-3235-1UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61577-3235-4UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61577-3235-5UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61577-3235-7UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61577-3235-6UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61577-3235-2UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61577-3235-8UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61577-3235-9UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61577-3235-1UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61577-3235-4UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61577-3235-5UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61577-3235-7UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61577-3235-6UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61577-3235-2UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61577-3235-8UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
SORE NO MORE COOL THERAPY
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL.06 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
415976Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9aa1f0ac-3baf-4e45-9e3a-c28a99b22909Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
61577-3235-12025-05-27Sore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-22025-05-27Sore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-42025-05-27Sore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-52025-05-27Sore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-62025-05-27Sore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-72025-05-27Sore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-82025-05-27Sore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-92025-05-27Sore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-12025-01-30Sore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-22025-01-30Sore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-42025-01-30Sore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-52025-01-30Sore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-62025-01-30Sore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-72025-01-30Sore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-82025-01-30Sore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-92025-01-30Sore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-12020-03-06Sore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-22020-03-06Sore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-42020-03-06Sore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-52020-03-06Sore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-62020-03-06Sore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-72020-03-06Sore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-82020-03-06Sore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-92020-03-06Sore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-12020-01-31Sore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-22020-01-31Sore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-42020-01-31Sore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-52020-01-31Sore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-62020-01-31Sore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-72020-01-31Sore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-82020-01-31Sore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-92020-01-31Sore No More Cool Therapy Natural Pain Relieving Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61577-3235-1SORE NO MORE COOL THERAPY226.8 g in 1 JARGEL226.812
61577-3235-2SORE NO MORE COOL THERAPY907.2 g in 1 BOTTLE, PUMPGEL907.212
61577-3235-4SORE NO MORE COOL THERAPY113.4 g in 1 JARGEL113.412
61577-3235-5SORE NO MORE COOL THERAPY85 g in 1 BOTTLE, PLASTICGEL8512
61577-3235-6SORE NO MORE COOL THERAPY113.4 g in 1 TUBEGEL113.412
61577-3235-7SORE NO MORE COOL THERAPY56.7 g in 1 JARGEL56.712
61577-3235-8SORE NO MORE COOL THERAPY28.3 g in 1 JARGEL28.312
61577-3235-9SORE NO MORE COOL THERAPY5 g in 1 POUCHGEL512

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61577-3235SORE NO MORE COOL THERAPY (MENTHOL) GEL [SOMBRA COSMETICS INC.]12Current NDC, Legacy NDC, 8 package rows20250529_9aa1f0ac-3baf-4e45-9e3a-c28a99b22909.zip
61577-3235ELEMAR PATCH (LIDOCAINE) KIT [V2 PHARMA, LLC]11Current NDC, Legacy NDC20250101_3de6bb95-3673-45c4-bf11-90ec858c37d9.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 4 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MAXIMUM STRENGTH Lidocaine Plus MentholLIDOCAINE, MENTHOLARMY AND AIR FORCE EXCHANGE SERVICE60f72061-d264-424e-b396-5a609076d3522026-08-20WarningsExact identifier
application number: M017
MENTHOL, CAMPHORMENTHOL, CAMPHORSUNSET PAIN RELIEF5980c527-6bcb-a846-e063-6294a90a07882026-08-20WarningsExact identifier
application number: M017
Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATEAmerisource Bergen5fb5e5ce-b268-4444-8b63-ea7ea6abf2692026-08-20WarningsExact identifier
application number: M017
Dr. Scholls Blister Pain Relief Complete KitLIDOCAINEScholl's Wellness Company LLC58c2b35c-e1ed-7ea8-e063-6294a90a14942026-08-19WarningsExact identifier
application number: M017
Dr. Scholls Blister Pain Relief Complete KitLIDOCAINEScholl's Wellness Company LLC585e740b-e4fa-d2aa-e063-6294a90a09822026-08-19WarningsExact identifier
application number: M017
Eagle Brand Muscular BalmMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA0822bcde-a8ad-be95-e063-6294a90ad2082026-08-19WarningsExact identifier
application number: M017
ANTI ITCHHYDROCORTISONEHyVee Inc1ab6bbb8-2b91-4c53-9168-b1e85ac296e92026-08-19WarningsExact identifier
application number: M017
hydrocortisone 1HYDROCORTISONEKroger Companyf05edff2-2dc5-427c-b52c-518e0aaef4e02026-08-19WarningsExact identifier
application number: M017
MedPrideHYDROCORTISONEShield Line LLC2f15d3b3-d1e6-4742-9eac-f956c0ffbba42026-08-18WarningsExact identifier
application number: M017
Pain Relieving Cream AnalgesicMENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATEGarcoa, Inc.2f736307-5cd4-4a76-9044-4aeecba096cc2026-08-18WarningsExact identifier
application number: M017
Lidocaine Pain Relief Roll onPAIN RELIEF ROLL ONNeilMed Pharmaceuticals Inc58ff9d2d-99e6-8f98-e063-6394a90a8de72026-08-17WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONE CREAM 1/2%Sun Pharmaceutical Industries, Inc.59337940-c9be-58af-e063-6394a90abe132026-08-16WarningsExact identifier
application number: M017
SIERQ NumbingMENTHOLPutian Licheng District Zhijiancheng Trading Co., Ltd.5936c070-d8e4-56e8-e063-6294a90a56002026-08-16WarningsExact identifier
application number: M017
Jakwork Numbing CreamNUMBING CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5911d9b0-1acb-3546-e063-6294a90adb3a2026-08-15WarningsExact identifier
application number: M017
Re-Lieved Lidocaine PatchLIDOCAINE PATCH 4%Transfer Technology59072f05-eefa-d823-e063-6394a90a0e1a2026-08-14WarningsExact identifier
application number: M017
JJ Care First Aid BurnBENZALKONIUM CHLORIDE, LIDOCAINE HCINantong Health & Beyond Hygienic Products Inc.c41621fb-c549-4394-a4cb-cb81ef8c98df2026-08-13WarningsExact identifier
application number: M017
JJ CareHYDROCORTISONENantong Health & Beyond Hygienic Products Inc.c88fa151-f8a8-4de2-98c9-71319bf53e362026-08-13WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONESafetec of America, Inc.da2b3b2c-11e0-401b-bbd2-d019271d1b3d2026-08-13WarningsExact identifier
application number: M017
CVS Pain Relief Roll-On Lidocaine with LavenderLIDOCAINE HYDROCHLORIDECVS Pharmacy4aa53176-2103-b47b-e063-6394a90ac7352026-08-12WarningsExact identifier
application number: M017
JUST CBD SOOTHINGMENTHOL, CAMPHORJust Brands LLC5384e80f-c242-76a1-e063-6294a90aba0b2026-08-12WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
415976menthol 6 % Topical GelPSN9aa1f0ac-3baf-4e45-9e3a-c28a99b2290912
415976menthol 0.06 MG/MG Topical GelSCD9aa1f0ac-3baf-4e45-9e3a-c28a99b2290912
415976menthol 6 % Topical GelSY9aa1f0ac-3baf-4e45-9e3a-c28a99b2290912

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61577-3235-161577323501226.8 g in 1 JAR (61577-3235-1) 226.8 g2016-06-140000-00-00NoNoCurrent
61577-3235-261577323502907.2 g in 1 BOTTLE, PUMP (61577-3235-2) 907.2 g2016-06-140000-00-00NoNoCurrent
61577-3235-461577323504113.4 g in 1 JAR (61577-3235-4) 113.4 g2016-06-140000-00-00NoNoCurrent
61577-3235-56157732350585 g in 1 BOTTLE, PLASTIC (61577-3235-5) 85 g2016-06-140000-00-00NoNoCurrent
61577-3235-661577323506113.4 g in 1 TUBE (61577-3235-6) 113.4 g2016-06-140000-00-00NoNoCurrent
61577-3235-76157732350756.7 g in 1 JAR (61577-3235-7) 56.7 g2016-06-140000-00-00NoNoCurrent
61577-3235-86157732350828.3 g in 1 JAR (61577-3235-8) 28.3 g2017-07-020000-00-00YesNoCurrent
61577-3235-9615773235095 g in 1 POUCH (61577-3235-9) 5 g2016-06-140000-00-00NoNoCurrent