FDA.reportPublic FDA data

Extra Strength Cold-Hot Medicated Patches

Product NDC
70000-0367
11-digit product format
700000367
Labeler code
70000
Product ID
70000-0367_45726e8d-072b-86e6-e063-6294a90a833e
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
PATCH
Route
TOPICAL
Labeler
Cardinal Health, 110 dba LEADER
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-01-01
Substance
MENTHOL
Active strength
5 g/1
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
Extra Strength Cold-Hot Medicated Patches
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL5 g/1

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
a2895c03-747c-4220-8052-4f0428062622Available 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
70000-0367-1Extra Strength Cold-Hot Medicated Patches5 in 1 BOXPATCH58
70000-0367-1Extra Strength Cold-Hot Medicated Patches1 in 1 POUCHPATCH18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0367-1EA - Each70000-0367d912fe63-7f8a-43e3-8305-9be556b2e51812020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0367EXTRA STRENGTH COLD-HOT MEDICATED PATCHES (MENTHOL) PATCH [CARDINAL HEALTH, 110 DBA LEADER]7Current NDC, Legacy NDC, 2 package rows20241222_a2895c03-747c-4220-8052-4f0428062622.zip

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 2 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ActivICEMENTHOLMedline Industries, LP834adeb9-38ad-0cfe-e053-2991aa0af82f2026-09-01WarningsExact identifier
application number: M017
La Vaquita New ExtraMETHYL SALICYLATE, MENTHOLDelon Laboratories (1990) Ltd3097a01b-cee5-492f-b65a-63992fb28e3a2026-09-01WarningsExact identifier
application number: M017
Terramed Just Think Comfort Hydrocortisone 1% CreamHYDROCORTISONERida LLC0d2c0c2c-370f-4adb-b0ea-1e218c927f8b2026-09-01WarningsExact identifier
application number: M017
Itch StoppingDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEHyVee Inc53157137-b980-45d2-aa10-8c111c0ec2f42026-08-31WarningsExact identifier
application number: M017
EAYONYUMT NECK PAIN RELIEFMENTHOLWuhan Ruihengjie Technology Co., Ltd.5a450e68-07a7-a4bb-e063-6294a90a97c92026-08-30WarningsExact identifier
application number: M017
EAYONYUM BACK PAIN RELIEVINGMENTHOLWuhan Ruihengjie Technology Co., Ltd.5a458280-4f9c-5af6-e063-6394a90acb2e2026-08-30WarningsExact identifier
application number: M017
EAYONYUM KNEE PAIN RELIEVINGMENTHOLWuhan Ruihengjie Technology Co., Ltd.5a45d19f-c753-71eb-e063-6294a90a48052026-08-30WarningsExact identifier
application number: M017
Good Neighbor Pharmacy Hydrocortisone With Aloe for Sensitive SkinHYDROCORTISONEAmerisourceBergenc5c5b5ca-b4d4-4fa8-b647-b3ccb29664952026-08-30WarningsExact identifier
application number: M017
Olu Pain ManagementLIDOCAINE AND CAMPHORHAWAII REPACK, INC.31ed3d82-ba12-46b2-b0ec-7e5e019efc102026-08-28WarningsExact identifier
application number: M017
4% Lidocaine Patches4% LIDOCAINE PATCHESShenzhen Chaoxiji Technology Co.,Ltd.5a177987-7c05-f07f-e063-6394a90aa9ba2026-08-28WarningsExact identifier
application number: M017
Relieved Pro Wrap4% LIDOCAINE PATCHTransfer Technology5a1c6ebf-ad3f-c47b-e063-6294a90aa19a2026-08-28WarningsExact identifier
application number: M017
Sinsinpas Arex Pain Relieving Patch, MediumCAMPHOR, MENTHOL, METHYL SALICYLATESinsin Pharmaceutical Co., Ltd.46453ef2-512b-4852-e063-6394a90a89122026-08-28WarningsExact identifier
application number: M017
Sinsinpas arex patch largeCAMPHOR, MENTHOL, METHYL SALICYLATESinsin Pharmaceutical Co., Ltd.47c242da-56cd-bea1-e063-6394a90a41de2026-08-28WarningsExact identifier
application number: M017
4% Lidocaine Patches4% LIDOCAINE PATCHESShenzhen Chaoxiji Technology Co.,Ltd.5a16c6aa-3ab0-3e46-e063-6294a90a6d8f2026-08-27WarningsExact identifier
application number: M017
Lidocaine Patch 4%LIDOCAINE 4%Global America Group LLC1eec782d-0e56-43d2-b842-da0ae47c5dc92026-08-26WarningsExact identifier
application number: M017
Careland Lidocaine Plus Menthol Pain RelievingLIDOCAINE, MENTHOLPlanet (Anhui) Pharmaceutical Co., Ltd0f928b5b-60f5-4a45-a409-c601eb3304872026-08-26WarningsExact identifier
application number: M017
PARCHE CALIENTECAPSAICINA AND MENTOLDW SUPPORT LLC59f2708e-295a-ccb3-e063-6394a90ad3952026-08-26WarningsExact identifier
application number: M017
CVS Pain ReliefLIDOCAINECVS Pharmacy4ecbc263-e0d4-18d5-e063-6294a90a72e92026-08-26WarningsExact identifier
application number: M017
CVS Pain Relief Lidocaine XLLIDOCAINECVS Pharmacy4aa286e3-e274-8095-e063-6394a90ae8712026-08-26WarningsExact identifier
application number: M017
TERAPIA DE DIA Y NOCHEPAIN RELIEVING PATCHDW SUPPORT LLC59f44135-865b-9d7d-e063-6294a90a9dd92026-08-26WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
420222menthol 5 % Medicated PatchPSNa2895c03-747c-4220-8052-4f04280626228
420222menthol 0.05 MG/MG Medicated PatchSCDa2895c03-747c-4220-8052-4f04280626228
420222menthol 5 % Medicated PatchSYa2895c03-747c-4220-8052-4f04280626228

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0367-1700000367015 POUCH in 1 BOX (70000-0367-1) / 1 PATCH in 1 POUCH5 pouch2019-01-010000-00-00NoNoCurrent