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 38 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Target Up and Up Pain Relief Menthol Topical AnalgesicMENTHOLTarget Corporation4910f32f-c639-0215-e063-6394a90a1c7b2026-01-23WarningsExact identifier
application number: M017
RapidolHYDROCORTISONEPharmadel LLC19a1f1e2-bc6b-7153-e063-6294a90ab1152026-01-23WarningsExact identifier
application number: M017
CVS 9083 Maximum Strength Lidocaine 4 Pain Relief Patch 1ct LargeLIDOCAINECVS PHARMACY, INC4914965f-1164-e20e-e063-6294a90ac2212026-01-23WarningsExact identifier
application number: M017
THE GOO MEDICATED PAIN RELIEFMETHYL SALICYLATE, MENTHOL, CAMPHORAPSM PERFORMANCE, LLCdb4c321c-8cdc-5a11-e053-2995a90a91a12026-01-23WarningsExact identifier
application number: M017
Dr SabharwalsLIDOCAINE 4% AND MENTHOL 1% PATCHDr. Sabharwal's Wound Care10249d0f-5ee1-6892-e063-6394a90a967e2026-01-23WarningsExact identifier
application number: M017
Easment DMSO creamMENTHOL 1.00%Easment LLC48f5544e-1cfd-864a-e063-6394a90a71f12026-01-22WarningsExact identifier
application number: M017
Aveeno 1% Hydrocortisone Anti-Itch CreamHYDROCORTISONEKenvue Brands LLC1ac0ac4e-af76-9a3e-e063-6394a90a12692026-01-22WarningsExact identifier
application number: M017
RAYO ACTIVE ICEMENTHOL, CAMPHORQuimicas Handal de Centroamerica SA de CV09e4a36b-020a-c5b1-e063-6394a90a3e312026-01-22WarningsExact identifier
application number: M017
X-Treme FreezeCOLD THERAPY GELDynarex Corporation79f0802f-03ad-bf8f-e053-2991aa0ae4b52026-01-22WarningsExact identifier
application number: M017
Anti ItchHYDROCORTISONEHyVee Incae31f1f5-db70-45cf-850e-67bfe68607482026-01-21WarningsExact identifier
application number: M017
ULTRA RELIEFMENTHOL, CAMPHORCHEMCO CORPORATION48ea80cf-af54-ce5f-e063-6394a90ac4932026-01-21WarningsExact identifier
application number: M017
Healthy Back Institute Rub On ReliefANALGESICEagle Labs Inc.17dff3c1-3c0b-16f6-e063-6394a90a3c052026-01-21WarningsExact identifier
application number: M017
Pain ReliefANALGESICFullstack Fulfillment2a433cee-8b6f-c280-e063-6394a90ae25a2026-01-21Exact identifier
application number: M017
Walgreens Anti Itch CreamANTI ITCH CREAMWalgreens Companyb545553a-283a-48af-adc5-763758a9ff242026-01-21WarningsExact identifier
application number: M017
CVS Health Maximum Strength Lidocaine Pain Relief Cream Plus MentholLIDOCAINE HCL, MENTHOLCVS Pharmacy8aaffa3f-f82f-470c-902d-f366f1a663052026-01-21WarningsExact identifier
application number: M017
LIGHTS Instant Sting Relief PadBENZOCAINELights Medical Manufacture Co., Ltd.28dd82a7-f360-a022-e063-6394a90a3a762026-01-21WarningsExact identifier
application number: M017
LIGHTS Insect Sting Relief PadBENZOCAINELights Medical Manufacture Co., Ltd.ccb4185c-1a67-4775-9392-16bc0f7df3cc2026-01-21WarningsExact identifier
application number: M017
Equate Pain Relieving Cream LidocaineLIDOCAINEWal-Mart Stores Inc52b91508-22aa-4c4b-94f4-977f14a01dad2026-01-20WarningsExact identifier
application number: M017
Easment advanced absorption creamCAPSAICIN 0.1%Easment LLC48de3ced-f67f-7c86-e063-6294a90a340c2026-01-20WarningsExact identifier
application number: M017
Black Cobra Tattoo NumbingSpray 4% LidocaineLIDOCAINEFoshan Sugar Max Cosmetics CO.,Ltd3605fcbf-63c8-87b5-e063-6294a90a9c3e2026-01-19WarningsExact 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