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 67 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
QIAN LI ZHUI FENG PAIN RELIEVINGCAMPHOR, MENTHOL, AND METHYL SALICYLATEMADISON ONE ACME INC03a4fb7c-2328-409d-99c8-cbcf2b4a451f2025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
WU YANG BRAND PAIN RELIEVING MEDICATEDMENTHOL AND CAMPHORMADISON ONE ACME INC05c6b95a-aeb6-4234-97c7-8d77eccb38d82025-11-10WarningsExact identifier
application number: M017
HEI GUI PAIN RELIEVINGCAMPHOR AND METHYL SALICYLATEMADISON ONE ACME INC4140c404-edab-4923-941d-f74125e943a92025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
E MEI SHAN MEDICATEDCAMPHOR AND MENTHOLMADISON ONE ACME INCddcc814e-fcc4-4232-9ab4-826b8aac35f02025-11-10Warnings, Adverse reactionsExact identifier
application number: M017
OvertimeMETHYL SALICYLATE, MENTHOL AND CAPSAICINPhysicians Science & Nature Inc.25fec070-8587-42d1-ba6f-1a9c150acc982025-11-10WarningsExact identifier
application number: M017
Dendracin NeurodendraxcinMETHYL SALICYLATE, MENTHOL AND CAPSAICINPhysicians Science & Nature Inc.05742cd5-ece2-4007-bdf0-46b76d23df742025-11-10WarningsExact identifier
application number: M017
Anal BluDESENSITIZERNovelties by Nasswalk, Inc.03b9555b-c3ff-4baa-e063-6394a90afb2c2025-11-10WarningsExact identifier
application number: M017
StallionDELAY CREMENovelties by Nasswalk, Inc.0261ec88-8fe4-d5f8-e063-6294a90ab3d42025-11-10WarningsExact identifier
application number: M017
ANAL-ESEDESENSITIZERNovelties by Nasswalk, Inc.03b89eed-b433-a263-e063-6294a90a675b2025-11-10WarningsExact identifier
application number: M017
Instant ErectionULTIMATE ERECTION ENHANCERNovelties by Nasswalk, Inc.03a444f9-7052-0c38-e063-6294a90a4e562025-11-10WarningsExact identifier
application number: M017
STA-HARDDESENSITIZING LUBRICANTNovelties by Nasswalk, Inc.02ef794b-8e70-5c26-e063-6294a90a28d12025-11-10WarningsExact identifier
application number: M017
ANAL-ESEDESENSITIZERNovelties by Nasswalk, Inc.03a4a7ce-4cff-a608-e063-6294a90ad65d2025-11-10WarningsExact identifier
application number: M017
FOOTSPA PEDIALCOHOLCHEMCO CORPORATION04de4392-74f6-7df8-e063-6294a90ae3b12025-11-08WarningsExact identifier
application number: M017
Johnson and Johnson All Purpose First Aid KitACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC5cdb47c5-7951-4279-8a05-0a3199d3dd452025-11-06WarningsExact identifier
application number: M017
Johnson and Johnson First Aid Travel Ready 80 CTACETAMINOPHEN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDEKenvue Brands LLCf388f105-48ba-4616-e053-2a95a90a00492025-11-06WarningsExact identifier
application number: M017
Johnson and Johnson First Aid All Purpose 160 CTACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLCf3933330-2550-4a88-e053-2a95a90a39972025-11-06WarningsExact identifier
application number: M017
Foot and Leg Pain ReliefLIDOCAINEPremier Brands of America Inc.42f23e2f-11c6-da49-e063-6294a90ac7202025-11-06WarningsExact identifier
application number: M017
HEALING TREE CALMING ANTI-ITCHHYDROCORTISONERenu Laboratories, LLCfc8bcde9-26e8-a35f-e053-6394a90a33002025-11-06WarningsExact identifier
application number: M017
Calamine PlusCALAMINE PLUS PRAMOXINE HCLChain Drug Marketing Association Inc1a3f8819-58cf-8923-e063-6394a90a37af2025-11-06WarningsExact identifier
application number: M017
Extra Strength Itch ReliefDIPHENHYDRAMINE HCL AND ZINC ACETATEChain Drug Marketing Association Inc1a2997bc-7741-e658-e063-6394a90af6fd2025-11-06WarningsExact 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