FDA.reportPublic FDA data

ZYLOTROL MAXIMUM PAIN

Product NDC
81902-104
11-digit product format
819020104
Labeler code
81902
Product ID
81902-104_08157e80-effb-147b-e063-6394a90aca36
Type
HUMAN OTC DRUG
Nonproprietary name
lidocaine 4%, menthol 1%
Dosage form
PATCH
Route
TOPICAL
Labeler
Whitestone Products LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-12-23
Substance
LIDOCAINE; MENTHOL
Active strength
.12; .03 g/3g; g/3g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ZYLOTROL MAXIMUM PAIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE.12 g/3g
MENTHOL.03 g/3g

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
81902-104-15ZYLOTROL MAXIMUM PAIN15 in 1 BOXPATCH152
81902-104-15ZYLOTROL MAXIMUM PAIN3 g in 1 PATCHPATCH32

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81902-104-15EA - Each81902-104c498d81e-2515-4da8-9ee2-b17d3ba709c512023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81902-104ZYLOTROL MAXIMUM PAIN (LIDOCAINE 4%, MENTHOL 1%) PATCH [WHITESTONE PRODUCTS LLC]2Current NDC, Legacy NDC, 2 package rows20231021_a80efad7-1d8b-4d8b-8c97-373174ce89ca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1249758lidocaine 4 % / menthol 1 % Medicated PatchPSN0bdfe510-c2ff-4f23-9e9b-6ec6cb5c91dd2
1249758lidocaine 4 % / menthol 1 % Medicated PatchPSNa80efad7-1d8b-4d8b-8c97-373174ce89ca2
1249758lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCD0bdfe510-c2ff-4f23-9e9b-6ec6cb5c91dd2
1249758lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCDa80efad7-1d8b-4d8b-8c97-373174ce89ca2
1249758lidocaine 4 % / menthol 1 % Medicated PatchSY0bdfe510-c2ff-4f23-9e9b-6ec6cb5c91dd2
1249758lidocaine 4 % / menthol 1 % Medicated PatchSYa80efad7-1d8b-4d8b-8c97-373174ce89ca2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81902-104-158190201041515 PATCH in 1 BOX (81902-104-15) / 3 g in 1 PATCH15 patch2022-12-230000-00-00NoNoCurrent