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

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 Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A
Rxcui415976

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61577-3235-12025-05-27C16284748780-19d75b9d0-9c55-f424-e053-dadaa90a57ceSore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-22025-05-27C16284748780-19d75b9d0-9c55-f424-e053-dadaa90a57ceSore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-42025-05-27C16284748780-19d75b9d0-9c55-f424-e053-dadaa90a57ceSore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-52025-05-27C16284748780-19d75b9d0-9c55-f424-e053-dadaa90a57ceSore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-62025-05-27C16284748780-19d75b9d0-9c55-f424-e053-dadaa90a57ceSore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-72025-05-27C16284748780-19d75b9d0-9c55-f424-e053-dadaa90a57ceSore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-82025-05-27C16284748780-19d75b9d0-9c55-f424-e053-dadaa90a57ceSore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-92025-05-27C16284748780-19d75b9d0-9c55-f424-e053-dadaa90a57ceSore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-12025-01-30C16284748780-19d75b9d0-9c55-f424-e053-dadaa90a57ceSore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-22025-01-30C16284748780-19d75b9d0-9c55-f424-e053-dadaa90a57ceSore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-42025-01-30C16284748780-19d75b9d0-9c55-f424-e053-dadaa90a57ceSore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-52025-01-30C16284748780-19d75b9d0-9c55-f424-e053-dadaa90a57ceSore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-62025-01-30C16284748780-19d75b9d0-9c55-f424-e053-dadaa90a57ceSore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-72025-01-30C16284748780-19d75b9d0-9c55-f424-e053-dadaa90a57ceSore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-82025-01-30C16284748780-19d75b9d0-9c55-f424-e053-dadaa90a57ceSore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-92025-01-30C16284748780-19d75b9d0-9c55-f424-e053-dadaa90a57ceSore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-12020-03-06C16284748780-19d75b9d0-9c55-f424-e053-dadaa90a57ceSore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-22020-03-06C16284748780-19d75b9d0-9c55-f424-e053-dadaa90a57ceSore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-42020-03-06C16284748780-19d75b9d0-9c55-f424-e053-dadaa90a57ceSore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-52020-03-06C16284748780-19d75b9d0-9c55-f424-e053-dadaa90a57ceSore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-62020-03-06C16284748780-19d75b9d0-9c55-f424-e053-dadaa90a57ceSore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-72020-03-06C16284748780-19d75b9d0-9c55-f424-e053-dadaa90a57ceSore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-82020-03-06C16284748780-19d75b9d0-9c55-f424-e053-dadaa90a57ceSore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-92020-03-06C16284748780-19d75b9d0-9c55-f424-e053-dadaa90a57ceSore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-12020-01-31C16284748780-19d75b9d0-9c55-f424-e053-dadaa90a57ceSore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-22020-01-31C16284748780-19d75b9d0-9c55-f424-e053-dadaa90a57ceSore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-42020-01-31C16284748780-19d75b9d0-9c55-f424-e053-dadaa90a57ceSore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-52020-01-31C16284748780-19d75b9d0-9c55-f424-e053-dadaa90a57ceSore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-62020-01-31C16284748780-19d75b9d0-9c55-f424-e053-dadaa90a57ceSore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-72020-01-31C16284748780-19d75b9d0-9c55-f424-e053-dadaa90a57ceSore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-82020-01-31C16284748780-19d75b9d0-9c55-f424-e053-dadaa90a57ceSore No More Cool Therapy Natural Pain Relieving Gel
61577-3235-92020-01-31C16284748780-19d75b9d0-9c55-f424-e053-dadaa90a57ceSore 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

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