FDA.reportPublic FDA data

Cutiecaine

Product NDC
51350-111
11-digit product format
513500111
Labeler code
51350
Product ID
51350-111_fde0012f-0f00-4d01-b3fc-2eabb4061dea
Type
HUMAN OTC DRUG
Nonproprietary name
Topical Lidocaine (5% w/w)
Dosage form
CREAM
Route
TOPICAL
Labeler
Transdermal Corp
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-11-15
Marketing end
0000-00-00
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
50 mg/g
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51350-111-022019-11-13C16284748780-197449f38-c6e0-f6ea-e053-dbdaa90aa703Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51350-111-01Cutiecaine15 g in 1 TUBECREAM151
51350-111-02Cutiecaine1 in 1 CARTONCREAM11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41ACUTIECAINE (TOPICAL LIDOCAINE (5% W/W)) CREAM [TRANSDERMAL CORP]1
LIDOCAINEACTIVE MOIETY98PI200987CUTIECAINE (TOPICAL LIDOCAINE (5% W/W)) CREAM [TRANSDERMAL CORP]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MCUTIECAINE (TOPICAL LIDOCAINE (5% W/W)) CREAM [TRANSDERMAL CORP]1
ALOEINACTIVE INGREDIENTV5VD430YW9CUTIECAINE (TOPICAL LIDOCAINE (5% W/W)) CREAM [TRANSDERMAL CORP]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RACUTIECAINE (TOPICAL LIDOCAINE (5% W/W)) CREAM [TRANSDERMAL CORP]1
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27ECUTIECAINE (TOPICAL LIDOCAINE (5% W/W)) CREAM [TRANSDERMAL CORP]1
CASTOR OILINACTIVE INGREDIENTD5340Y2I9GCUTIECAINE (TOPICAL LIDOCAINE (5% W/W)) CREAM [TRANSDERMAL CORP]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNCUTIECAINE (TOPICAL LIDOCAINE (5% W/W)) CREAM [TRANSDERMAL CORP]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCUTIECAINE (TOPICAL LIDOCAINE (5% W/W)) CREAM [TRANSDERMAL CORP]1
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4THCUTIECAINE (TOPICAL LIDOCAINE (5% W/W)) CREAM [TRANSDERMAL CORP]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302CUTIECAINE (TOPICAL LIDOCAINE (5% W/W)) CREAM [TRANSDERMAL CORP]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHCUTIECAINE (TOPICAL LIDOCAINE (5% W/W)) CREAM [TRANSDERMAL CORP]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCUTIECAINE (TOPICAL LIDOCAINE (5% W/W)) CREAM [TRANSDERMAL CORP]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APCUTIECAINE (TOPICAL LIDOCAINE (5% W/W)) CREAM [TRANSDERMAL CORP]1
WATERINACTIVE INGREDIENT059QF0KO0RCUTIECAINE (TOPICAL LIDOCAINE (5% W/W)) CREAM [TRANSDERMAL CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51350-111CUTIECAINE (TOPICAL LIDOCAINE (5% W/W)) CREAM [TRANSDERMAL CORP]1Legacy NDC, 2 package rows20111116_4b743662-1ac0-4682-86d0-5488e72f3095.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1491882lidocaine HCl 5 % Topical CreamPSN4b743662-1ac0-4682-86d0-5488e72f30951
1491882lidocaine hydrochloride 50 MG/ML Topical CreamSCD4b743662-1ac0-4682-86d0-5488e72f30951
1491882lidocaine hydrochloride 5 % Topical CreamSY4b743662-1ac0-4682-86d0-5488e72f30951

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
51350-111-015135001110115 g in 1 TUBE15 gHistorical
51350-111-02513500111021 in 1 CARTONHistorical