COLD AND HOT MEDICATED LARGE

Product NDC
52000-421
11-digit product format
520000421
Labeler code
52000
Product ID
52000-421_6e490a04-d32f-4dec-9ced-ab55fae6efb1
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
PATCH
Route
TOPICAL
Labeler
Universal Distribution Center LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-11-25
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
.05 g/g
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
COLD AND HOT MEDICATED LARGE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM.05 g/g

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
420222Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d6780230-aa96-4055-b054-be41358568b6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52000-421-41COLD AND HOT MEDICATED LARGE19 g in 1 PATCHPATCH197
52000-421-41COLD AND HOT MEDICATED LARGE1 in 1 POUCHPATCH17
52000-421-42COLD AND HOT MEDICATED LARGE1 in 1 POUCHPATCH17
52000-421-42COLD AND HOT MEDICATED LARGE24 in 1 BOXPATCH247

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 26 of 156 · 3,115 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SINSIN MULPASL-MENTHOL, METHYL SALICYLATE, DL-CAMPHORSinsin Pharmaceutical Co., Ltd.47c077c2-6e34-8e7a-e063-6294a90a21b52026-04-08WarningsExact identifier
application number: M017
Yi Tiao Gen Pain PatchPAIN PATCHSheng Chang Pharmaceutical Co, Ltd. Zhongli Factory4828fe70-f6f8-45e4-9c9a-a9e486dc65e52026-04-07WarningsExact identifier
application number: M017
Dermatool Nerve CareLIDOCAINE HCL, MENTHOLPapalo Group, LLC4ee40c96-9350-4c68-e063-6294a90ac8122026-04-07WarningsExact identifier
application number: M017
Burn ReliefLIDOCAINECVS Pharmacy, Inc.42b3c341-f422-b2b4-e063-6294a90a47b22026-04-06WarningsExact identifier
application number: M017
KinetiCream Pain Relieving Topical AnalgesicMENTHOLPhoenix Bioperformance Products LLCbb4c9e73-e62d-4b8c-a16c-b90db1a8b2a72026-04-06WarningsExact identifier
application number: M017
KinetiCream Anti-Inflammatory and Pain ReliefMENTHOLPhoenix Bioperformance Products LLC39a6d26b-b5f4-45d7-a9b5-6edbf42d75002026-04-06WarningsExact identifier
application number: M017
Dr. Blue PainZaway Pain Relieving Roll-OnMENTHOLIndiana Botanic Gardens4ecc8241-5a87-2f45-e063-6294a90aa30a2026-04-06WarningsExact identifier
application number: M017
Sunburn Relief GelLIDOCAINE HCLCVS Pharmacy, Inc.d7f52394-5cc1-48a6-ae89-9fc63b5157582026-04-06Warnings, Adverse reactionsExact identifier
application number: M017
Pain-Relieving PatchCAMPHOR, MENTHOL, METHYL SALICYLATECVS Pharmacy4ecf4a6e-5c0f-7943-e063-6394a90a81cc2026-04-06WarningsExact identifier
application number: M017
RAPID RELIEF0.025% CAPSAICIN PAIN PATCHRAPID AID VIET NAM COMPANY LIMITED4edbaa1a-6e44-4865-e063-6394a90a8cc32026-04-06WarningsExact identifier
application number: M017
Capsaicin 0.1% CreamCAPSAICIN 0.1%Puretek Corporation4e83441b-cb6a-beb0-e063-6394a90a1b542026-04-03WarningsExact identifier
application number: M017
NeroCare Capsaicin Neuropathy Relief CreamCAPSAICINGuangzhou Tata Biotechnology Co., Ltd.4e89b7eb-0d84-dc57-e063-6394a90a7dd92026-04-03WarningsExact identifier
application number: M017
TheraCare Pain Relief PatchLIDOCAINE 4%Veridian Healthcare4e91da65-8191-6261-e063-6394a90a6bd52026-04-03WarningsExact identifier
application number: M017
HealthWise Roll-OnLIDOCAINE, MENTHOLVeridian Healthcare4e9306b5-949e-f7a9-e063-6394a90ae13a2026-04-03WarningsExact identifier
application number: M017
Dr SabharwalsLIDOCAINE 4% GEL PATCHDr. Sabharwal's Wound Care102399b6-5be9-ee5e-e063-6394a90a31982026-04-02WarningsExact identifier
application number: M017
TATTOO NUMBX NUMBING PAIN RELIEVINGLIDOCAINE HYDROCHLORIDEScyberco Ltdac8eac04-ed5b-4c8e-9f9b-54d160b746062026-04-02WarningsExact identifier
application number: M017
FifthPulse HydrocortisoneHYDROCORTISONEWeCare Products LLCf1fcb045-4a15-431b-9617-67eae9f87fbd2026-04-02WarningsExact identifier
application number: M017
ANIXIKE CreamMENTHOL 5% CREAMJiangxi Yudexi Pharmaceutical Co., LTD4e8510e6-c0c7-bf6b-e063-6294a90a3b002026-04-02WarningsExact identifier
application number: M017
RAPID RELIEF0.025% CAPSAICIN PAIN PATCH835694ed549e8-0062-fb03-e063-6294a90aac652026-04-02WarningsExact identifier
application number: M017
Itch ReliefDIPHENHYDRAMINE HCL AND ZINC ACETATECVS Pharmacy7e921988-ec66-38dc-e053-2a91aa0a73462026-04-01WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
420222menthol 5 % Medicated PatchPSNd6780230-aa96-4055-b054-be41358568b67
420222menthol 0.05 MG/MG Medicated PatchSCDd6780230-aa96-4055-b054-be41358568b67
420222menthol 5 % Medicated PatchSYd6780230-aa96-4055-b054-be41358568b67

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
52000-421-41520000421411 PATCH in 1 POUCH (52000-421-41) / 19 g in 1 PATCH1 patch2024-11-25NoNoCurrent
52000-421-425200004214224 POUCH in 1 BOX (52000-421-42) / 1 PATCH in 1 POUCH / 19 g in 1 PATCH24 pouch2024-11-25NoNoCurrent