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 26 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr SabharwalsLIDOCAINE 4% GEL PATCHDr. Sabharwal's Wound Care102399b6-5be9-ee5e-e063-6394a90a31982026-04-02WarningsExact identifier
application number: M017
TATTOO NUMBX NUMBING PAIN RELIEVINGLIDOCAINE HYDROCHLORIDEScyberco Ltdac8eac04-ed5b-4c8e-9f9b-54d160b746062026-04-02WarningsExact identifier
application number: M017
FifthPulse HydrocortisoneHYDROCORTISONEWeCare Products LLCf1fcb045-4a15-431b-9617-67eae9f87fbd2026-04-02WarningsExact identifier
application number: M017
ANIXIKE CreamMENTHOL 5% CREAMJiangxi Yudexi Pharmaceutical Co., LTD4e8510e6-c0c7-bf6b-e063-6294a90a3b002026-04-02WarningsExact identifier
application number: M017
RAPID RELIEF0.025% CAPSAICIN PAIN PATCH835694ed549e8-0062-fb03-e063-6294a90aac652026-04-02WarningsExact identifier
application number: M017
Itch ReliefDIPHENHYDRAMINE HCL AND ZINC ACETATECVS Pharmacy7e921988-ec66-38dc-e053-2a91aa0a73462026-04-01WarningsExact identifier
application number: M017
The Best Numbing CreamTBNCThe Best Numbing Cream LLC4ca3923b-f586-0aaf-e063-6294a90a16c12026-03-31WarningsExact identifier
application number: M017
ChapStick Classic MedicatedEXTERNAL ANALGESIC AND SKIN PROTECTANT LIP BALMSuave Brands Co., LLC42798a6c-2d7e-80f6-e063-6294a90a105f2026-03-31WarningsExact identifier
application number: M017
Roll-On Pain Relief LiquidLIDOCAINE HCLHyVee Inc4da6f6fb-b182-360f-e063-6294a90abdf32026-03-31WarningsExact identifier
application number: M017
Hand SanitizerALCOHOLProStat First Aid4e54aecb-190f-3866-e063-6294a90a810a2026-03-31WarningsExact identifier
application number: M017
Burn MistLIDOCAINE HYDROCHLORIDEWater-Jel Technologiesc53ab9dd-351a-400b-b873-4f396e0af54d2026-03-31WarningsExact identifier
application number: M017
Satohap Lidocaine Hydrochloride 4 Percent Pain RelievingLIDOCAINE HYDROCHLORIDESato Pharmaceutical Co., Ltd.f7faddb2-5153-4fdd-a5ef-778182cef4602026-03-31WarningsExact identifier
application number: M017
ZENOL COOLMETHYL SALICYLATE, L-MENTHOLBA TRADE INC4e5c45f4-88ce-3a13-e063-6394a90a2a092026-03-31WarningsExact identifier
application number: M017
Eagle Brand Medicated Roll On RefreshCAMPHOR, MENTHOLBorden Company (Private) Limited091451fb-e30a-0012-e063-6394a90a3ba82026-03-31WarningsExact identifier
application number: M017
Icy Hot Revive and Recovery Pain Relief No- Mess Roll On Refreshing Lime and MintMENTHOLChattem, Inc.b16ba9c2-23bf-4fdf-b44b-7abb9fec19112026-03-31WarningsExact identifier
application number: M017
DR.PABU NUMBINGLIDOCAINE 5% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4e3a3c6c-4821-76ea-e063-6294a90a8f962026-03-30WarningsExact identifier
application number: M017
Doctor Jiao Antifungal CreamMICONAZOLE NITRATEJiangxi Haiwei Pharmaceutical Co., Ltd.4e3b231e-0642-bf63-e063-6394a90a905b2026-03-30WarningsExact identifier
application number: M017
CVS Muscle Balm and Roll-OnCAMPHOR, MENTHOLCVS Pharmacy4e40025a-070a-508e-e063-6394a90af5d72026-03-30WarningsExact identifier
application number: M017
REGENECARE HALIDOCAINE HCLMPM Medical LLCc3eec066-38e8-4617-b34d-2f72ffb7a3242026-03-30WarningsExact identifier
application number: M017
Softlips Naturals Medicated Matcha HoneyCAMPHOR, MENTHOLThe Mentholatum Company4e03a721-73f3-b2f2-e063-6394a90a44e62026-03-27WarningsExact 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