FDA.reportPublic FDA data

Pain Relief Hot Patch

Product NDC
52000-046
11-digit product format
520000046
Labeler code
52000
Product ID
52000-046_fffe712b-e02a-4acd-8420-f0223244e0f7
Type
HUMAN OTC DRUG
Nonproprietary name
menthol and capsaicin
Dosage form
PATCH
Route
TOPICAL
Labeler
Universal Distribution Center LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-03-23
Substance
MENTHOL, UNSPECIFIED FORM; CAPSAICIN
Active strength
30; .83 mg/g; mg/g
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
Pain Relief Hot Patch
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM30 mg/g
CAPSAICIN.83 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup
S07O44R1ZMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1484488Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
110bcb16-ef0b-4bc8-8877-173a0494e1adAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52000-046-41Pain Relief Hot Patch8.5 g in 1 PATCHPATCH8.57
52000-046-41Pain Relief Hot Patch2 in 1 POUCHPATCH27
52000-046-42Pain Relief Hot Patch2 in 1 POUCHPATCH27
52000-046-42Pain Relief Hot Patch1 in 1 BOXPATCH17
52000-046-43Pain Relief Hot Patch24 in 1 BOXPATCH247
52000-046-43Pain Relief Hot Patch2 in 1 POUCHPATCH27

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 33 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
blue goo Pain RelievingMENTHOL 2.5%Garcoa, Inc.7b9b5ac6-9568-464c-8096-0302a1e650df2026-02-13WarningsExact identifier
application number: M017
Methyl Salicylate 30 Percent CreamMETHYL SALICYLATEAlexso, Inc1d50ccb2-1a5d-49c7-8524-2f54eed63e852026-02-13WarningsExact identifier
application number: M017
Antiseptic Mouth RinseEUCALYPTOL, MENTHOL, METHYOL SALICYLATE, THYMOLTopco Associates LLCa38e91c1-7ac6-4a7f-a5a2-8d9166b1535a2026-02-13Warnings, Adverse reactionsExact identifier
application number: M017
Gel Cooling Pain ReliefMENTHOLTopco Associates LLC80962394-a46f-48fd-8e0c-685dd1e500d72026-02-13Warnings, Adverse reactionsExact identifier
application number: M017
BanophenDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEMajor Pharmaceuticals9758d886-bd58-4eb2-a827-fa8e7fee2b7c2026-02-13WarningsExact identifier
application number: M017
Natureplex Hydrocortisone HydroHYDROCORTISONENatureplex, LLC2fc6a148-34bb-4289-8588-32c1bb011b982026-02-13WarningsExact identifier
application number: M017
Capsaicin 0.035 PercentCAPSAICINAlexso, Inc6d0bc1cc-e812-4753-b20c-c0357dd6deb52026-02-13WarningsExact identifier
application number: M017
Swiftalyn Numbing CreamLIDOCAINE 4%GENUINE INNOVATION LTD3f74c4a6-26f0-ddf7-e063-6394a90a12252026-02-12WarningsExact identifier
application number: M017
PHARMBANNER Arnica Bruise CreamARNICA BRUISE CREAMShenzhen Xinxin Yunhai Technology Co., Ltd.3c783061-8e2d-8a84-e063-6394a90a52652026-02-12WarningsExact identifier
application number: M017
ETERNAL SPIRIT BEAUTY PAIN RELIEF WITH HEMPMENTHOL, CAMPHORWorldwide Cosmetics, Inc459d64a9-0538-57c8-e063-6394a90a61552026-02-12WarningsExact identifier
application number: M017
Antiseptic Mouth RinseEUCALYPTOLWalgreen Co.cba60e9d-5f12-4c56-9fa5-6ce1514fc2b02026-02-12Warnings, Adverse reactionsExact identifier
application number: M017
Medicated Body PowderMENTHOLWalmart Stores Incafd337b7-d76e-f17a-e053-2a95a90abac72026-02-12WarningsExact identifier
application number: M017
Lidocaine Hydrochloride 2%LIDOCAINE HYDROCHLORIDEAldermed Inc.4977b722-d08d-3d9e-e063-6294a90a90352026-02-12WarningsExact identifier
application number: M017
Ice Gel ICE COLD ANALGESICMENTHOLJell Pharmaceuticals Pvt Ltd4a8b3f84-8c45-eb94-e063-6394a90a3e732026-02-11WarningsExact identifier
application number: M017
Walgreens Pain Relieving Lidocaine PatchLIDOCAINEWalgreen Co.41c4e9fe-e407-b22a-e063-6394a90a4b272026-02-10WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE CREAM 1%Aldermed Inc.4a7f2c0e-5cf3-29cb-e063-6394a90a5d8d2026-02-10WarningsExact identifier
application number: M017
MENTHOL, CAMPHORMENTHOL, CAMPHORSUNSET PAIN RELIEF4a7f92d3-dd35-44a3-e063-6294a90ae0042026-02-10WarningsExact identifier
application number: M017
NICOVITO HEMORRHOID MASTERLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID MASTERJiangxi Yudexi Pharmaceutical Co., LTD4a5e24fa-959e-79b4-e063-6294a90a8f682026-02-09WarningsExact identifier
application number: M017
Tiger Balm Active Muscle RubMETHYL SALICYLATE, MENTHOL, UNSPECIFIED FORM, AND CAMPHOR (SYNTHETIC)Haw Par Healthcare Ltd.2e7638c6-e1ce-4e2f-bd50-52fbce5a138e2026-02-09WarningsExact identifier
application number: M017
Tiger Balm Neck and Shoulder RubCAMPHOR (SYNTHETIC) AND MENTHOLHaw Par Healthcare Ltd.2f272d12-7b34-430e-817e-1005f57ed9e92026-02-09WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1484488capsaicin 8.3 MG / menthol 30 MG in 1 GM Medicated PatchPSN110bcb16-ef0b-4bc8-8877-173a0494e1ad7
1484488capsaicin 0.0083 MG/MG / menthol 0.03 MG/MG Medicated PatchSCD110bcb16-ef0b-4bc8-8877-173a0494e1ad7
1484488capsaicin 0.83 % / menthol 3 % Medicated PatchSY110bcb16-ef0b-4bc8-8877-173a0494e1ad7
1484488capsaicin 8.3 MG / menthol 30 MG per 1 GM Medicated PatchSY110bcb16-ef0b-4bc8-8877-173a0494e1ad7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52000-046-41520000046412 PATCH in 1 POUCH (52000-046-41) / 8.5 g in 1 PATCH2 patch2024-12-02NoNoCurrent
52000-046-42520000046421 POUCH in 1 BOX (52000-046-42) / 2 PATCH in 1 POUCH / .206 g in 1 PATCH1 pouch2020-03-230000-00-00NoNoCurrent
52000-046-435200000464324 POUCH in 1 BOX (52000-046-43) / 2 PATCH in 1 POUCH / 8.5 g in 1 PATCH24 pouch2024-12-02NoNoCurrent