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 129 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fruit of the Earth Aloe Vera Cool BlueLIDOCAINE HYDROCHLORIDEFruit of the Earth, Inc.1d65bc34-2bc2-4f52-a9b3-1cb08324eb792024-07-19WarningsExact identifier
application number: M017
Ultra BalmMENTHOL AND METHYL SALICYLATELing Nam Medicine Factory (H.K.) Ltd.de997baf-aa04-474e-b912-3fc67e720d0b2024-07-19WarningsExact identifier
application number: M017
Ling Nam Hak Kwai OilTURPENTINE OILLing Nam Medicine Factory (H.K.) Ltd.3f16cce3-366f-41f3-8829-6de4082a8c192024-07-19WarningsExact identifier
application number: M017
Koong Yick Hak Kwai OilTURPENTINE OILLing Nam Medicine Factory (H.K.) Ltd.bc33e185-3b42-98b5-e053-2995a90a63082024-07-18WarningsExact identifier
application number: M017
Koong Yick Hung FaMETHYL SALICYLATELing Nam Medicine Factory (H.K.) Ltd.9c8a121d-6da2-4435-a2d7-a0b71d10740d2024-07-18WarningsExact identifier
application number: M017
Ling Nam Hung FarMETHYL SALICYLATELing Nam Medicine Factory (H.K.) Ltd.b6916b6e-b7eb-1eb7-e053-2995a90ae6fb2024-07-18WarningsExact identifier
application number: M017
itch reliefDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEBionpharma Inc.178ed513-4f22-8f11-e063-6294a90a109b2024-07-16WarningsExact identifier
application number: M017
POWERECT Benzocaine Male Delay GelBENZOCAINESKINS SEXUAL HEALTH LIMITED2fafe1f2-a31e-4b2a-bc51-81e16b319c3a2024-07-16WarningsExact identifier
application number: M017
SKINS DELAY Climax Control Benzocaine GelBENZOCAINESKINS SEXUAL HEALTH LIMITED53730576-2609-4f28-8bfa-a1ceea698b832024-07-16WarningsExact identifier
application number: M017
TIDL PAIN RELIEF CRYO THERAPY Unscented formula Spray.PAIN RELIEF CRYO THERAPY UNSCENTED FORMULA SPRAYShenzhen Sam Technology Co., Ltd.1d1a0346-3b00-4803-e063-6294a90aec6d2024-07-13WarningsExact identifier
application number: M017
Tidl Pain Relief Evening Therapy Spray.PAIN RELIEF EVENING THERAPY SPRAYShenzhen Sam Technology Co., Ltd.1d1a2f4a-7b25-e595-e063-6394a90a00d52024-07-13WarningsExact identifier
application number: M017
TIDL PAIN RELIEF HEAT THERAPY ROLL-ONPAIN RELIEF HEAT THERAPY ROLL-ONShenzhen Sam Technology Co., Ltd.1d0b7b8f-9e5d-00f7-e063-6394a90af87c2024-07-12WarningsExact identifier
application number: M017
TIDL PAIN RELIEF CRYO THERAPY original formula Spray.PAIN RELIEF CRYO THERAPY ORIGINAL FORMULA SPRAYShenzhen Sam Technology Co., Ltd.1d0b94ec-f956-dff2-e063-6294a90aca4a2024-07-12WarningsExact identifier
application number: M017
TIDL PAIN RELIEF CRYO THERAPY MAX Strength Spray.PAIN RELIEF CRYO THERAPY MAX STRENGTH SPRAYShenzhen Sam Technology Co., Ltd.1d0bf4f9-6b02-6cec-e063-6294a90a36c72024-07-12WarningsExact identifier
application number: M017
Burn ReliefLIDOCAINE HCI 2.0%Trifecta Pharmaceuticals USA, LLC.e5e524cd-bb22-715f-e053-2995a90ab5d32024-07-12WarningsExact identifier
application number: M017
Ralli Rapid Pain ReliefMENTHOLTroy Manufacturing, Inc.1d10e3ca-dc93-8e1a-e063-6394a90a47c02024-07-12WarningsExact identifier
application number: M017
TIDL PAIN RELIEF HEAT THERAPY Spray.PAIN RELIEF HEAT THERAPY SPRAYShenzhen Sam Technology Co., Ltd.1d199826-1b27-b6e7-e063-6394a90a69ad2024-07-12WarningsExact identifier
application number: M017
Tidl Pain Relief Morning Therapy Spray.PAIN RELIEF MORNING THERAPY SPRAYShenzhen Sam Technology Co., Ltd.1d19d070-3818-73de-e063-6394a90a89582024-07-12WarningsExact identifier
application number: M017
Hydrocortisone with aloeHYDROCORTISONE WITH ALOE ANTI ITCHNeilMed Pharmaceuticals Inc.032b9f58-5f64-04dd-e063-6294a90a6bb92024-07-10WarningsExact identifier
application number: M017
Octagon Pain ReliefMENTHOL, UNSPECIFIED FORMNATURAL ESSENTIALS, INC.9926f733-1506-4224-9d70-b1813cd81ec32024-07-08WarningsExact 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