Overnight Cold Therapy Pain Relief

Product NDC
0363-0355
11-digit product format
003630355
Labeler code
0363
Product ID
0363-0355_5f845434-d8db-4bfa-8fc0-8a9b9205f194
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
2023-12-04
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
Overnight 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
2cbd0966-4cf9-4271-bd53-6672b1ed2a99Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0355-03Overnight Cold Therapy Pain Relief89 mL in 1 TUBEGEL892
0363-0355-25Overnight Cold Therapy Pain Relief74 mL in 1 BOTTLE, WITH APPLICATORGEL742

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0355OVERNIGHT COLD THERAPY PAIN RELIEF (MENTHOL, UNSPECIFIED FORM) GEL [WALGREEN CO.]2Current NDC, 2 package rows20231216_2cbd0966-4cf9-4271-bd53-6672b1ed2a99.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 88 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hilook Blue Gel AnestheticLIDOCAINEGuangdong Aimu Biological Technology Co., Ltd1b9db681-a297-5aa9-e063-6394a90a80ea2025-06-25WarningsExact identifier
application number: M017
Hilook Numbing CreamLIDOCAINEGuangdong Aimu Biological Technology Co., Ltd1b9f1a4c-ca0b-d820-e063-6394a90a32392025-06-25WarningsExact identifier
application number: M017
Lidocaine Knee Pain Relief Gel-PatchLIDOCAINEGuangzhou Zhupuyou E-commerce Co., Ltd384c1ff8-80bd-86cb-e063-6394a90a2d652025-06-24WarningsExact identifier
application number: M017
Aroamas Cot Nicotine Transdermal Patches KitNICOTINE TRANSDERMAL PATCHESPCHEERY LLC38576022-9413-c9af-e063-6294a90afd462025-06-24WarningsExact identifier
application number: M017
NERVE REVERSE PAIN RELIEFMENTHOLPogue Medical Servicesda97bcc6-5aa8-48e2-a2c2-c937745bf6d32025-06-23WarningsExact identifier
application number: M017
Medterra Pain Relief Menthol Roll-OnMENTHOLRespect Manufacturing Corporation05a6067a-287a-52d4-e063-6394a90a2c4e2025-06-23WarningsExact identifier
application number: M017
Medterra Pain Relief 500mg Hemp Menthol CreamMENTHOLRespect Manufacturing Corporation06c4640a-ee42-5d1a-e063-6394a90ad2542025-06-23WarningsExact identifier
application number: M017
Medterra Pain Relief 1000mg Hemp Menthol CreamMENTHOLRespect Manufacturing Corporation06e944e8-71f6-9fe9-e063-6294a90a8c372025-06-23WarningsExact identifier
application number: M017
Procure gelMENTHOLTWIN MED, LLCe69c0b68-d408-9fd2-e053-2a95a90ac9342025-06-20WarningsExact identifier
application number: M017
A Health Itch Relief GelITCH RELIEF GELBionpharma, Inc.38040732-48c9-3533-e063-6394a90af10a2025-06-20WarningsExact identifier
application number: M017
SCHOELIF Numbing CreamNUMBING CREAMGuangzhou Qiexiran Cosmetics Co., Ltd.37eaabb7-884e-0bd5-e063-6294a90ae0632025-06-19WarningsExact identifier
application number: M017
Re-Lieved Lidocaine PatchLIDOCAINE PATCH 4%Transfer Technology37ee539c-df7e-511d-e063-6394a90a44692025-06-19WarningsExact identifier
application number: M017
Re-Lieved Lidocaine PatchLIDOCAINE PATCH 4%Transfer Technology37eef80a-556f-b090-e063-6294a90a151b2025-06-19WarningsExact identifier
application number: M017
Re-Lieved Lidocaine PatchLIDOCAINE PATCH 4%Transfer Technology37ef02d4-2ff5-cb23-e063-6294a90a68af2025-06-19WarningsExact identifier
application number: M017
Post-Treatment Repair CreamHYDROCORTISONEVi Medical Products Inc.ab8885a9-0778-28ff-e053-2995a90a2e122025-06-19WarningsExact identifier
application number: M017
MyDermLIDOCAINEInspec Solutions LLC.82d075d1-c92e-2097-e053-2991aa0ab1312025-06-18WarningsExact identifier
application number: M017
Walgreens Extra Small LidocaineLIDOCAINEWalgreen Co.dc838e47-d234-4ba5-9449-f645e99be9232025-06-18WarningsExact identifier
application number: M017
CLn Body MoisturizerCOLLOIDAL OAT MOISTURIZERTopMD Skin Care, Inc.2de3d68d-a540-d456-e063-6394a90a4b572025-06-18WarningsExact identifier
application number: M017
Aloe UP SPF 30 MineralZINC OXIDE, TITANIUM DIOXIDEAloe Care International, LLC35967b33-bdfb-ee3c-e063-6294a90a75f62025-06-18WarningsExact identifier
application number: M017
Aloe Up SPF 50 MineralZINC OXIDE, TITANIUM DIOXIDEAloe Care International, LLC35b9dcfa-05f3-3d7b-e063-6394a90a18f12025-06-18WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-0355-030036303550389 mL in 1 TUBE (0363-0355-03) 89 ml2023-12-04NoNoCurrent
0363-0355-250036303552574 mL in 1 BOTTLE, WITH APPLICATOR (0363-0355-25) 74 ml2023-12-04NoNoCurrent