Cold Therapy Pain Relief

Product NDC
0363-0356
11-digit product format
003630356
Labeler code
0363
Product ID
0363-0356_f2ea3545-6938-4a13-8969-32f38f3d9fff
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol, unspecified form
Dosage form
GEL
Route
TOPICAL
Labeler
Walgreen Co.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-04-01
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
36 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
Cold Therapy Pain Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM36 mg/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
ede15818-5d17-477d-a8be-7b36bb0770a6Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0356-03Cold Therapy Pain Relief89 mL in 1 TUBEGEL891
0363-0356-25Cold Therapy Pain Relief74 mL in 1 BOTTLE, WITH APPLICATORGEL741

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0356COLD THERAPY PAIN RELIEF (MENTHOL, UNSPECIFIED FORM) GEL [WALGREEN CO.]1Current NDC, 2 package rows20240425_ede15818-5d17-477d-a8be-7b36bb0770a6.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 96 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Soothing Lavender Foot Soak and Body SoakCAMPHORSANSAR, LLCef26523a-b2f2-466e-89ad-f293cd64decb2025-03-27WarningsExact identifier
application number: M017
Achelon Lidocaine PatchLIDOCAINE PATCH 4%Achelon, Inc31408e21-e58d-6db5-e063-6294a90aa4bc2025-03-26WarningsExact identifier
application number: M017
Achelon Lidocaine PatchLIDOCAINE PATCH 4%Achelon, Inc3143bb72-2969-d66e-e063-6294a90a46042025-03-26WarningsExact identifier
application number: M017
Parche LeonCAPSAICIN, CAMPHOR, MENTHOLPharmadel LLCa8f266fa-6e43-559e-e053-2995a90a2c752025-03-26WarningsExact identifier
application number: M017
Adellina Numbing CreamLIDOCAINEGuangzhou Haishi Biological Technology Co., Ltd.314a83fe-8bdb-766f-e063-6294a90a61c62025-03-26WarningsExact identifier
application number: M017
HealthWise Lidocaine Plus Menthol PatchLIDOCAINE AND MENTHOLVeridian Healthcare312f15fe-9297-2dc2-e063-6294a90a6f4d2025-03-25WarningsExact identifier
application number: M017
HealthWise Lidocaine PatchLIDOCAINE 4%Veridian Healthcare3130729d-1679-90cd-e063-6294a90a21e62025-03-25WarningsExact identifier
application number: M017
HealthWise Lidocaine PatchLIDOCAINE 4%Veridian Healthcare31314dda-6199-574d-e063-6394a90aae7a2025-03-25WarningsExact identifier
application number: M017
RWSEFK Lidocaine Pain Relief Gel-PatchLIDOCAINE PAIN RELIEF GEL-PATCHHenan Enokon Medical Instrument Co., Ltd.31366793-f8a6-a2c4-e063-6294a90acbfc2025-03-25WarningsExact identifier
application number: M017
Forticept Wounds and Burns HydrogelBENZETHONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDELidan, inc.c6f58b63-9838-4ff4-8b1a-de2d41d6cf5f2025-03-25WarningsExact identifier
application number: M017
MQ Pain Relieving PatchPAIN RELIEVING PATCHZhengzhou Miaoqi Pharmaceutical Technology Co., Ltd0978ff22-c357-e266-e063-6394a90a98a42025-03-24WarningsExact identifier
application number: M017
LidoPro Patch (Lidocaine 4%, Menthol 1%)LIDOCAINE AND MENTHOL PATCHAdvanced Rx of Tennessee, LLC30c97646-db06-df84-e063-6394a90a77432025-03-20WarningsExact identifier
application number: M017
Carmex Classic Lip Balm MedicatedCAMPHOR (SYNTHETIC), PETROLATUMCarma Laboratories, Inc.fb6eb93b-7dc0-4b6f-bfe1-1a7b47588e572025-03-20WarningsExact identifier
application number: M017
Carmex Variety Pack Classic Medicated Lip Balm Daily Care Lip Balm SPFCAMPHOR (SYNTHETIC), WHITE PETROLATUM OCTINOXATE, OXYBENZONE, AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECarma Laboratories, Inc.5f904369-5f21-4907-98de-df23bce308232025-03-20WarningsExact identifier
application number: M017
DermaCort Anti-itchHYDROCORTISONEMelaleuca, Inc.24044b0f-dd1e-4762-82b8-7a28b08c2f772025-03-20WarningsExact identifier
application number: M017
AUVON Lidocaine Menthol Pain Relief PatchLIDOCAINE AND MENTHOLSHENZHEN YUWEN E-COMMERCE CO., LTD.300cf469-5ca2-a40d-e063-6294a90a68012025-03-20WarningsExact identifier
application number: M017
Carmex Variety Pack Classic Medicated Lip Balm Lip Balm SPF 15CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONECarma Laboratories, Inc.3a3af6e1-0281-462e-85e7-144cc5d46f322025-03-19WarningsExact identifier
application number: M017
Lidocaine 4%LIDOCAINEInnovida Pharmaeutique Corporationeb83a3dd-557e-4334-b806-5fc05e9175a32025-03-19WarningsExact identifier
application number: M017
Carmex Variety Pack Classic Medicated Lip Balm Lip Balm SPF 15CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONECarma Laboratories, Inc.c04059e9-8175-46c2-8582-f84ef193abd32025-03-19WarningsExact identifier
application number: M017
Carmex Variety Pack Classic Medicated Lip Balm Lip Balm SPF 15CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONECarma Laboratories, Inc.3a36a241-37a9-445a-a6e0-97709a7457a82025-03-19WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-0356-030036303560389 mL in 1 TUBE (0363-0356-03) 89 ml2024-04-01NoNoCurrent
0363-0356-250036303562574 mL in 1 BOTTLE, WITH APPLICATOR (0363-0356-25) 74 ml2024-04-01NoNoCurrent