HealthWise Soothing Cold Therapy Gel

Product NDC
71101-050
11-digit product format
711010050
Labeler code
71101
Product ID
71101-050_1f2ef992-1262-4b39-e063-6394a90a6dd9
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol 4%
Dosage form
GEL
Route
TOPICAL
Labeler
Veridian Healthcare
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-01-01
Substance
MENTHOL
Active strength
4 g/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
HealthWise Soothing Cold Therapy Gel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL4 g/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1f09ccdd-09d8-6a8d-e063-6394a90a184fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71101-050-01HealthWise Soothing Cold Therapy Gel88.7 mL in 1 BOTTLEGEL88.72
71101-050-01HealthWise Soothing Cold Therapy Gel1 in 1 BOXGEL12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71101-050HEALTHWISE SOOTHING COLD THERAPY GEL (MENTHOL 4%) GEL [VERIDIAN HEALTHCARE]2Current NDC, 2 package rows20240809_1f09ccdd-09d8-6a8d-e063-6394a90a184f.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 42 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cortizone 10 Fast Acting Itch Relief CoolingHYDROCORTISONEChattem, Inc.01cd77e3-380f-4487-ae6e-3ac45355d8a42026-01-14WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEPadagis Israel Pharmaceuticals Ltd0174411c-1b10-4298-b820-87b24065b1182026-01-14WarningsExact identifier
application number: M017
Cortizone 10 Intensive Healing for EczemaHYDROCORTISONEChattem, Inc.31dc0f1f-ddd8-41dc-b669-b24655634d552026-01-14WarningsExact identifier
application number: M017
Cortisone 10 Overnight CremeHYDROCORTISONEChattem, Inc.ef2eda7e-d6a8-47e3-9d80-6074af6773dc2026-01-14WarningsExact identifier
application number: M017
CVS Pain Relief Lavender ScentMENTHOL 4%CVS484b0833-9f8a-f155-e063-6294a90a18692026-01-13WarningsExact identifier
application number: M017
EARTHS CARE ANTI-ITCHCAMPHOR (NATURAL), MENTHOLDLC Laboratories, Inc.d1eabb5f-7086-4ff0-a398-3703c9ecd4412026-01-13WarningsExact identifier
application number: M017
HealthWise Cold Therapy Menthol Pain ReliefMENTHOLVeridian Healthcare25e3d9cd-6ba3-4e06-8853-324b9d6692482026-01-13WarningsExact identifier
application number: M017
Pain ReleaseMENTHOLSaje Natural Business Inc.1ac2ed54-194c-4de2-8e7f-6e74ca32aa402026-01-13WarningsExact identifier
application number: M017
Pain Release Joint and Arthritis CreamMENTHOLSaje Natural Business Inc.18b24d75-17f7-1a35-e063-6394a90a55e02026-01-13WarningsExact identifier
application number: M017
Pain ReleaseMENTHOLSaje Natural Business Inc.a32b0950-3467-4e37-988d-104836af59712026-01-13WarningsExact identifier
application number: M017
Pain ReleaseMENTHOLSaje Natural Business Inc.92eec6e7-0367-43c6-bd28-1762390a71142026-01-13WarningsExact identifier
application number: M017
Pain ReleaseMENTHOLSaje Natural Business Inc.481a493b-0620-46ac-8228-e9964b7eb24b2026-01-13WarningsExact identifier
application number: M017
RestoralMENTHOLSaje Natural Business Inc.5b6176c1-9ed9-1950-e053-2a91aa0a434e2026-01-13WarningsExact identifier
application number: M017
Aspercreme Lidocaine with Eucalyptus Essential OilLIDOCAINE HCLChattem, Inc.03e247b4-a2e2-4354-a018-880f1bc987fd2026-01-13WarningsExact identifier
application number: M017
Aspercreme Lidocaine Foot (Diabetic)LIDOCAINE HYDROCHLORIDEChattem, Inc.2c33d15e-5032-46d9-bd98-5abc7df3bbe52026-01-13WarningsExact identifier
application number: M017
Aspercreme with Lidocaine Essential Oils Rosemary MintLIDOCAINEChattem, Inc.9c81d5eb-fa9b-47fb-8924-6ebf6a5c6bab2026-01-13WarningsExact identifier
application number: M017
Capzasin HP Arthritis Pain ReliefCAPSAICINChattem, Inc.345c9159-0efe-436b-9068-3b717678936b2026-01-13WarningsExact identifier
application number: M017
Capzasin Quick ReliefCAPSAICIN AND MENTHOLChattem, Inc.d6c313a3-8dc6-4231-95b6-ac9399e1c1be2026-01-13WarningsExact identifier
application number: M017
Aspercreme Pain RelievingTROLAMINE SALICYLATEChattem, Inc.97dd587b-ecc3-4b4b-a116-6355d3c6ea6d2026-01-13WarningsExact identifier
application number: M017
Dr Wellskin Numbing Cream4% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD482f25cc-dee3-c3b6-e063-6294a90a86742026-01-12WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71101-050-01711010050011 BOTTLE in 1 BOX (71101-050-01) / 88.7 mL in 1 BOTTLE1 bottle2024-08-01NoNoCurrent