FDA.reportPublic FDA data

FOOT WORKS MAXIMUM CRACKED HEEL

Product NDC
68577-195
11-digit product format
685770195
Labeler code
68577
Product ID
68577-195_29f92230-d1d5-5e94-e063-6294a90af812
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE, LIDOCAINE
Dosage form
CREAM
Route
TOPICAL
Labeler
COSMAX USA, CORPORATION
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-08-01
Substance
BENZALKONIUM CHLORIDE; LIDOCAINE
Active strength
1.3; 40 mg/mL; mg/mL
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
FOOT WORKS MAXIMUM CRACKED HEEL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1.3 mg/mL
LIDOCAINE40 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7, 98PI200987
Rxcui1356071

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
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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68577-195-00FOOT WORKS MAXIMUM CRACKED HEEL750 mL in 1 TUBECREAM7501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68577-195FOOT WORKS MAXIMUM CRACKED HEEL (BENZALKONIUM CHLORIDE, LIDOCAINE) CREAM [COSMAX USA, CORPORATION]1Current NDC, 1 package rows20241225_29f92230-d1d4-5e94-e063-6294a90af812.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1356071benzalkonium chloride 0.13 % / lidocaine 4 % Topical CreamPSN29f92230-d1d4-5e94-e063-6294a90af8121
1356071benzalkonium chloride 1.3 MG/ML / lidocaine 40 MG/ML Topical CreamSCD29f92230-d1d4-5e94-e063-6294a90af8121
1356071benzalkonium chloride 0.13 % / lidocaine 4 % Topical CreamSY29f92230-d1d4-5e94-e063-6294a90af8121

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68577-195-0068577019500750 mL in 1 TUBE (68577-195-00) 750 ml2024-08-01NoNoHistorical