FDA.reportPublic FDA data

PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)

Product NDC
84165-013
11-digit product format
841650013
Labeler code
84165
Product ID
84165-013_375bc794-328a-e610-e063-6294a90a4f9b
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
GEL
Route
TOPICAL
Labeler
Guangzhou Zhupuyou E-commerce Co., Ltd
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-12
Substance
MENTHOL
Active strength
4 g/100mL
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
PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL4 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
415974Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
375bc794-3289-e610-e063-6294a90a4f9bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84165-013-01PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)74 mL in 1 BOTTLEGEL741
84165-013-01PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)1 in 1 BOXGEL11
84165-013-02PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)2 in 1 BOXGEL21
84165-013-02PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)74 mL in 1 BOTTLEGEL741
84165-013-03PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)3 in 1 BOXGEL31
84165-013-03PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)74 mL in 1 BOTTLEGEL741
84165-013-04PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)74 mL in 1 BOTTLEGEL741
84165-013-04PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)4 in 1 BOXGEL41
84165-013-05PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)5 in 1 BOXGEL51
84165-013-05PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)74 mL in 1 BOTTLEGEL741
84165-013-06PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)74 mL in 1 BOTTLEGEL741
84165-013-06PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)6 in 1 BOXGEL61
84165-013-07PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)74 mL in 1 BOTTLEGEL741
84165-013-07PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)7 in 1 BOXGEL71
84165-013-08PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)8 in 1 BOXGEL81
84165-013-08PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)74 mL in 1 BOTTLEGEL741
84165-013-09PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)9 in 1 BOXGEL91
84165-013-09PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)74 mL in 1 BOTTLEGEL741
84165-013-10PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)74 mL in 1 BOTTLEGEL741
84165-013-10PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis)10 in 1 BOXGEL101

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 89 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Aloe Up SPF 50 MineralZINC OXIDEAloe International, LLC35bc3621-f4e4-42d3-e063-6394a90a7aad2025-06-18WarningsExact identifier
application number: M017
Aloe Up SPF 50 Kids MineralZINC OXIDE, TITANIUM DIOXIDEAloe Care International, LLC35cd16b0-bd81-8f68-e063-6294a90a3d8c2025-06-18WarningsExact identifier
application number: M017
Aloe Up SPF 50 Kids MineralZINC OXIDEAloe International, LLC35cd5542-947d-a042-e063-6394a90a13f82025-06-18WarningsExact identifier
application number: M017
Relieve Your PainMENTHOLProximity Capital Partners LLC dba Asutrac12369dd-8305-edaf-e053-2995a90a0d3d2025-06-18WarningsExact identifier
application number: M017
Melt Pain AwayCAPSAICINProximity Capital Partners LLC dba Asutraa95a11d7-a2ae-6654-e053-2a95a90a802c2025-06-18WarningsExact identifier
application number: M017
Recovery Roll-OnMENTHOL, CAMPHORPROXIMITY CAPITAL PARTNERS LLC DBA ASUTRAebc9630f-6d8b-e4f0-e053-2995a90a0b492025-06-18WarningsExact identifier
application number: M017
ProCure Hydrocortisone 1%HYDROCORTISONETwin Med LLC37cdfabc-1fdb-246a-e063-6394a90a008a2025-06-17WarningsExact identifier
application number: M017
ProCure Hydrocortisone 1%HYDROCORTISONETwin Med LLC37ce6c35-b211-43de-e063-6294a90ab7732025-06-17WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONE CREAM 1%Sun Pharmaceutical Industries, Inc.312ddc8d-100e-cfac-e063-6294a90acd092025-06-16WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
415974menthol 4 % Topical GelPSN375bc794-3289-e610-e063-6294a90a4f9b1
415974menthol 0.04 MG/MG Topical GelSCD375bc794-3289-e610-e063-6294a90a4f9b1
415974menthol 4 % Topical GelSY375bc794-3289-e610-e063-6294a90a4f9b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84165-013-01841650013011 BOTTLE in 1 BOX (84165-013-01) / 74 mL in 1 BOTTLE1 bottle2025-06-12NoNoCurrent
84165-013-02841650013022 BOTTLE in 1 BOX (84165-013-02) / 74 mL in 1 BOTTLE2 bottle2025-06-12NoNoCurrent
84165-013-03841650013033 BOTTLE in 1 BOX (84165-013-03) / 74 mL in 1 BOTTLE3 bottle2025-06-12NoNoCurrent
84165-013-04841650013044 BOTTLE in 1 BOX (84165-013-04) / 74 mL in 1 BOTTLE4 bottle2025-06-12NoNoCurrent
84165-013-05841650013055 BOTTLE in 1 BOX (84165-013-05) / 74 mL in 1 BOTTLE5 bottle2025-06-12NoNoCurrent
84165-013-06841650013066 BOTTLE in 1 BOX (84165-013-06) / 74 mL in 1 BOTTLE6 bottle2025-06-12NoNoCurrent
84165-013-07841650013077 BOTTLE in 1 BOX (84165-013-07) / 74 mL in 1 BOTTLE7 bottle2025-06-12NoNoCurrent
84165-013-08841650013088 BOTTLE in 1 BOX (84165-013-08) / 74 mL in 1 BOTTLE8 bottle2025-06-12NoNoCurrent
84165-013-09841650013099 BOTTLE in 1 BOX (84165-013-09) / 74 mL in 1 BOTTLE9 bottle2025-06-12NoNoCurrent
84165-013-108416500131010 BOTTLE in 1 BOX (84165-013-10) / 74 mL in 1 BOTTLE10 bottle2025-06-12NoNoCurrent