FDA.reportPublic FDA data

OKeeffes Working Hands Pain Relief

Product NDC
71564-009
11-digit product format
715640009
Labeler code
71564
Product ID
71564-009_2cca0907-5d70-e478-e063-6294a90ad19d
Type
HUMAN OTC DRUG
Nonproprietary name
allantoin, lidocaine hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
The Gorilla Glue Company/O'Keeffe's Company
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-07
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 Working Hands Pain Relief
Brand name suffix
Skin Protectant
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
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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71564-009-03OKeeffes Working Hands Pain ReliefSkin Protectant85 g in 1 TUBECREAM853
71564-009-03OKeeffes Working Hands Pain ReliefSkin Protectant1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71564-009OKEEFFES WORKING HANDS PAIN RELIEF SKIN PROTECTANT (ALLANTOIN, LIDOCAINE HYDROCHLORIDE) CREAM [THE GORILLA GLUE COMPANY/O'KEEFFE'S COMPANY]3Current NDC, 2 package rows20250130_0685da25-c9fa-e1cd-e063-6394a90ae1b3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2594492allantoin 0.5 % / lidocaine HCl 4 % Topical CreamPSN0685da25-c9fa-e1cd-e063-6394a90ae1b33
2594492allantoin 5 MG/ML / lidocaine hydrochloride 40 MG/ML Topical CreamSCD0685da25-c9fa-e1cd-e063-6394a90ae1b33
2594492allantoin 0.5 % / lidocaine hydrochloride 4 % Topical CreamSY0685da25-c9fa-e1cd-e063-6394a90ae1b33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71564-009-03715640009031 TUBE in 1 CARTON (71564-009-03) / 85 g in 1 TUBE1 tube2023-10-07NoNoHistorical