SORE NO MORE WARM THERAPY

Product NDC
61577-3234
11-digit product format
615773234
Labeler code
61577
Product ID
61577-3234_34f862b6-eefe-92fc-e063-6294a90a5242
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL and CAMPHOR
Dosage form
GEL
Route
TOPICAL
Labeler
SOMBRA COSMETICS INC.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-06-13
Substance
CAMPHOR (SYNTHETIC); MENTHOL
Active strength
.03; .03 g/g; 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 WARM THERAPY
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC).03 g/g
MENTHOL.03 g/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5TJD82A1ET, L7T10EIP3A
Rxcui630714

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
111d457e-3138-4512-b0ba-d0cd760c4055Product name320250225
0426261e-1bb9-b78b-abd2-80da765a7e3eProduct name220240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7Product name520240320
0ac2f11f-f58d-baf2-71a0-680993b48a61Product name220231211
855d63c3-b090-4636-8fc7-6d39ad23c44fProduct name120230829
bb58f410-04be-65dd-9211-e89ead899698Product name620230323
0fcbc38a-8b29-3348-1cef-5222ea53484fProduct name420220516
c4e1eedc-aca2-4551-8382-89144ed9d049Product name320220126
8d368a34-1453-43ea-828d-0dbcd72b8794Product name820210622
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
d6bab9d2-edce-a213-4796-226ab15472c3Product name620200616
2487e6ef-d419-42fc-aaf8-7acc805d2370Product name220170718
e071c814-e5e7-e7ed-ec76-428765d9c66bProduct name220151120
93148e06-b8d7-4e6c-853e-62f807d17fbbProduct name120151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247eProduct name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61577-3234-22025-05-12C16284748780-19d75b9cf-ec48-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-32025-05-12C16284748780-19d75b9cf-ec48-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-42025-05-12C16284748780-19d75b9cf-ec48-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-52025-05-12C16284748780-19d75b9cf-ec48-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-62025-05-12C16284748780-19d75b9cf-ec48-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-72025-05-12C16284748780-19d75b9cf-ec48-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-82025-05-12C16284748780-19d75b9cf-ec48-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-92025-05-12C16284748780-19d75b9cf-ec48-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-22025-01-30C16284748780-19d75b9cf-ec48-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-32025-01-30C16284748780-19d75b9cf-ec48-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-42025-01-30C16284748780-19d75b9cf-ec48-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-52025-01-30C16284748780-19d75b9cf-ec48-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-62025-01-30C16284748780-19d75b9cf-ec48-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-72025-01-30C16284748780-19d75b9cf-ec48-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-82025-01-30C16284748780-19d75b9cf-ec48-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-92025-01-30C16284748780-19d75b9cf-ec48-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-22020-03-06C16284748780-19d75b9cf-ec48-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-32020-03-06C16284748780-19d75b9cf-ec48-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-42020-03-06C16284748780-19d75b9cf-ec48-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-52020-03-06C16284748780-19d75b9cf-ec48-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-62020-03-06C16284748780-19d75b9cf-ec48-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-72020-03-06C16284748780-19d75b9cf-ec48-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-82020-03-06C16284748780-19d75b9cf-ec48-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-92020-03-06C16284748780-19d75b9cf-ec48-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-22020-01-31C16284748780-19d75b9cf-ec48-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-32020-01-31C16284748780-19d75b9cf-ec48-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-42020-01-31C16284748780-19d75b9cf-ec48-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-52020-01-31C16284748780-19d75b9cf-ec48-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-62020-01-31C16284748780-19d75b9cf-ec48-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-72020-01-31C16284748780-19d75b9cf-ec48-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-82020-01-31C16284748780-19d75b9cf-ec48-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel
61577-3234-92020-01-31C16284748780-19d75b9cf-ec48-f424-e053-dadaa90a57ceSore No More Warm Therapy Natural Pain Relieving Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61577-3234-2SORE NO MORE WARM THERAPY907.2 g in 1 BOTTLE, PUMPGEL907.29
61577-3234-3SORE NO MORE WARM THERAPY226.8 g in 1 JARGEL226.89
61577-3234-4SORE NO MORE WARM THERAPY113.4 g in 1 JARGEL113.49
61577-3234-5SORE NO MORE WARM THERAPY85 g in 1 BOTTLE, PLASTICGEL859
61577-3234-6SORE NO MORE WARM THERAPY113.4 g in 1 TUBEGEL113.49
61577-3234-7SORE NO MORE WARM THERAPY56.7 g in 1 JARGEL56.79
61577-3234-8SORE NO MORE WARM THERAPY28.3 g in 1 PACKAGEGEL28.39
61577-3234-9SORE NO MORE WARM THERAPY5 g in 1 POUCHGEL59
61577-3234-5Inflatherm85 g in 1 BOTTLE, PLASTICGEL85 g0.03 g in 1g6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61577-3234SORE NO MORE WARM THERAPY (MENTHOL AND CAMPHOR) GEL [SOMBRA COSMETICS INC.]9Current NDC, Legacy NDC, 8 package rows20250514_cd86b56e-9b4c-4aca-9740-c8793cb12055.zip
61577-3234INFLATHERM (DICLOFENAC SODIUM AND MENTHOL / CAMPHOR GEL) KIT [V2 PHARMA, LLC]6Current NDC, Legacy NDC20240820_b62f4306-8dbd-4501-8b1e-9aa78f9aee06.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
630714camphor 3 % / menthol 3 % Topical GelPSNcd86b56e-9b4c-4aca-9740-c8793cb120559
630714camphor 0.03 MG/MG / menthol 0.03 MG/MG Topical GelSCDcd86b56e-9b4c-4aca-9740-c8793cb120559
630714camphor 3 % / menthol 3 % Topical GelSYcd86b56e-9b4c-4aca-9740-c8793cb120559
630714camphor 3 % / menthol 3 % Topical GelPSNb62f4306-8dbd-4501-8b1e-9aa78f9aee066
855926diclofenac sodium 75 MG Delayed Release Oral TabletPSNb62f4306-8dbd-4501-8b1e-9aa78f9aee066
630714camphor 0.03 MG/MG / menthol 0.03 MG/MG Topical GelSCDb62f4306-8dbd-4501-8b1e-9aa78f9aee066
855926diclofenac sodium 75 MG Delayed Release Oral TabletSCDb62f4306-8dbd-4501-8b1e-9aa78f9aee066
630714camphor 3 % / menthol 3 % Topical GelSYb62f4306-8dbd-4501-8b1e-9aa78f9aee066

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61577-3234-261577323402907.2 g in 1 BOTTLE, PUMP (61577-3234-2) 907.2 g2016-06-140000-00-00NoNoCurrent
61577-3234-361577323403226.8 g in 1 JAR (61577-3234-3) 226.8 g2016-06-140000-00-00NoNoCurrent
61577-3234-461577323404113.4 g in 1 JAR (61577-3234-4) 113.4 g2016-06-140000-00-00NoNoCurrent
61577-3234-56157732340585 g in 1 BOTTLE, PLASTIC (61577-3234-5) 85 g2016-06-140000-00-00NoNoCurrent
61577-3234-661577323406113.4 g in 1 TUBE (61577-3234-6) 113.4 g2016-06-140000-00-00NoNoCurrent
61577-3234-76157732340756.7 g in 1 JAR (61577-3234-7) 56.7 g2016-06-140000-00-00NoNoCurrent
61577-3234-86157732340828.3 g in 1 PACKAGE (61577-3234-8) 28.3 g2017-06-010000-00-00YesNoCurrent
61577-3234-9615773234095 g in 1 POUCH (61577-3234-9) 5 g2016-06-140000-00-00NoNoCurrent