FDA.reportPublic FDA data

OKeeffes Healthy Feet

Product NDC
71564-006
11-digit product format
715640006
Labeler code
71564
Product ID
71564-006_0e77166a-8f68-eb67-e063-6394a90a1f12
Type
HUMAN OTC DRUG
Nonproprietary name
Allantoin, Lidocaine
Dosage form
CREAM
Route
TOPICAL
Labeler
The Gorilla Glue Company/O'Keeffe's Company
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-03-01
Substance
ALLANTOIN; LIDOCAINE HYDROCHLORIDE
Active strength
.5; 4 g/100g; g/100g
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
OKeeffes Healthy Feet
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALLANTOIN.5 g/100g
LIDOCAINE HYDROCHLORIDE4 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii344S277G0Z, V13007Z41A
Rxcui2594492

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71564-006-03OKeeffes Healthy Feet85 g in 1 TUBECREAM852
71564-006-03OKeeffes Healthy Feet1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71564-006OKEEFFES HEALTHY FEET (ALLANTOIN, LIDOCAINE) CREAM [THE GORILLA GLUE COMPANY/O'KEEFFE'S COMPANY]2Current NDC, Legacy NDC, 2 package rows20240110_d73709db-3932-3c56-e053-2995a90a7d0a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2594492allantoin 0.5 % / lidocaine HCl 4 % Topical CreamPSNd73709db-3932-3c56-e053-2995a90a7d0a2
2594492allantoin 5 MG/ML / lidocaine hydrochloride 40 MG/ML Topical CreamSCDd73709db-3932-3c56-e053-2995a90a7d0a2
2594492allantoin 0.5 % / lidocaine hydrochloride 4 % Topical CreamSYd73709db-3932-3c56-e053-2995a90a7d0a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71564-006-03715640006031 TUBE in 1 CARTON (71564-006-03) / 85 g in 1 TUBE1 tube2022-03-010000-00-00NoNoCurrent