FDA.reportPublic FDA data

Cold and Heat Lidocaine Patch Plus Menthol

Product NDC
70000-0558
11-digit product format
700000558
Labeler code
70000
Product ID
70000-0558_51c99f5c-204c-dd76-e063-6294a90a4a56
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine, Menthol
Dosage form
PATCH
Route
TOPICAL
Labeler
Cardinal Health, 110 dba LEADER
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-07-01
Substance
LIDOCAINE; MENTHOL, UNSPECIFIED FORM
Active strength
4; 1 g/100g; g/100g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cold and Heat Lidocaine Patch Plus Menthol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE4 g/100g
MENTHOL, UNSPECIFIED FORM1 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii98PI200987, L7T10EIP3A
Rxcui1249758

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0558-1Cold and Heat Lidocaine Patch Plus Menthol9 g in 1 PATCHPATCH96
70000-0558-1Cold and Heat Lidocaine Patch Plus Menthol5 in 1 POUCHPATCH56

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0558-1EA - Each70000-055809c3a28b-28df-4967-b54b-0019196fe34412021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0558COLD AND HEAT LIDOCAINE PATCH PLUS MENTHOL (LIDOCAINE, MENTHOL) PATCH [CARDINAL HEALTH, 110 DBA LEADER]4Current NDC, Legacy NDC, 2 package rows20241222_77066d01-75b0-4a8d-88d3-c639626d3326.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1249758lidocaine 4 % / menthol 1 % Medicated PatchPSN77066d01-75b0-4a8d-88d3-c639626d33266
1249758lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCD77066d01-75b0-4a8d-88d3-c639626d33266
1249758lidocaine 4 % / menthol 1 % Medicated PatchSY77066d01-75b0-4a8d-88d3-c639626d33266

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0558-1700000558015 PATCH in 1 POUCH (70000-0558-1) / 9 g in 1 PATCH5 patch2018-07-010000-00-00NoNoCurrent