FDA.reportPublic FDA data

Bikini Zone Medicated CREME

Product NDC
61543-1601
11-digit product format
615431601
Labeler code
61543
Product ID
61543-1601_eff14d9c-3c24-2f9d-e053-2995a90a3846
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE
Dosage form
CREAM
Route
TOPICAL
Labeler
CCA Industries, Inc.
Application
part333B
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-06-03
Marketing end
0000-00-00
Substance
LIDOCAINE
Active strength
2 g/100g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
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
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
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
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61543-1601-12024-01-30C16284748780-1ba0f9c33-1078-a910-e053-dadaa90a0b85Bikini Zone Medicated CREME
61543-1601-12022-12-16C16284748780-1ba0f9c33-1078-a910-e053-dadaa90a0b85Bikini Zone Medicated CREME
61543-1601-12021-01-29C16284748780-1ba0f9c33-1078-a910-e053-dadaa90a0b85Bikini Zone Medicated CREME

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61543-1601-1Bikini Zone Medicated CREME1 in 1 BOXCREAM17
61543-1601-1Bikini Zone Medicated CREME28 g in 1 TUBECREAM287

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINEACTIVE INGREDIENT98PI200987BIKINI ZONE MEDICATED CREME (LIDOCAINE) CREAM [CCA INDUSTRIES, INC.]4
LIDOCAINEACTIVE MOIETY98PI200987BIKINI ZONE MEDICATED CREME (LIDOCAINE) CREAM [CCA INDUSTRIES, INC.]4
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHBIKINI ZONE MEDICATED CREME (LIDOCAINE) CREAM [CCA INDUSTRIES, INC.]4
CAMPHOR (NATURAL)INACTIVE INGREDIENTN20HL7Q941BIKINI ZONE MEDICATED CREME (LIDOCAINE) CREAM [CCA INDUSTRIES, INC.]4
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SBIKINI ZONE MEDICATED CREME (LIDOCAINE) CREAM [CCA INDUSTRIES, INC.]4
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RBIKINI ZONE MEDICATED CREME (LIDOCAINE) CREAM [CCA INDUSTRIES, INC.]4
CYCLOMETHICONE 6INACTIVE INGREDIENTXHK3U310BABIKINI ZONE MEDICATED CREME (LIDOCAINE) CREAM [CCA INDUSTRIES, INC.]4
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4BIKINI ZONE MEDICATED CREME (LIDOCAINE) CREAM [CCA INDUSTRIES, INC.]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KBIKINI ZONE MEDICATED CREME (LIDOCAINE) CREAM [CCA INDUSTRIES, INC.]4
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4BIKINI ZONE MEDICATED CREME (LIDOCAINE) CREAM [CCA INDUSTRIES, INC.]4
HEXYLENE GLYCOLINACTIVE INGREDIENTKEH0A3F75JBIKINI ZONE MEDICATED CREME (LIDOCAINE) CREAM [CCA INDUSTRIES, INC.]4
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATBIKINI ZONE MEDICATED CREME (LIDOCAINE) CREAM [CCA INDUSTRIES, INC.]4
MENTHOLINACTIVE INGREDIENTL7T10EIP3ABIKINI ZONE MEDICATED CREME (LIDOCAINE) CREAM [CCA INDUSTRIES, INC.]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TBIKINI ZONE MEDICATED CREME (LIDOCAINE) CREAM [CCA INDUSTRIES, INC.]4
OCTYLDODECANOLINACTIVE INGREDIENT461N1O614YBIKINI ZONE MEDICATED CREME (LIDOCAINE) CREAM [CCA INDUSTRIES, INC.]4
POLYOXYL 100 STEARATEINACTIVE INGREDIENTYD01N1999RBIKINI ZONE MEDICATED CREME (LIDOCAINE) CREAM [CCA INDUSTRIES, INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BIKINI ZONE MEDICATED CREME (LIDOCAINE) CREAM [CCA INDUSTRIES, INC.]4
PROPYLENE GLYCOL DICAPRYLATEINACTIVE INGREDIENT581437HWX2BIKINI ZONE MEDICATED CREME (LIDOCAINE) CREAM [CCA INDUSTRIES, INC.]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHBIKINI ZONE MEDICATED CREME (LIDOCAINE) CREAM [CCA INDUSTRIES, INC.]4
SALICYLIC ACIDINACTIVE INGREDIENTO414PZ4LPZBIKINI ZONE MEDICATED CREME (LIDOCAINE) CREAM [CCA INDUSTRIES, INC.]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IBIKINI ZONE MEDICATED CREME (LIDOCAINE) CREAM [CCA INDUSTRIES, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RBIKINI ZONE MEDICATED CREME (LIDOCAINE) CREAM [CCA INDUSTRIES, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61543-1601BIKINI ZONE MEDICATED CREME (LIDOCAINE) CREAM [CCA INDUSTRIES, INC.]7Legacy NDC, 2 package rows20221217_091169e6-5021-431e-ab68-8c10e4f8f0c5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106222lidocaine 2 % Topical CreamPSN091169e6-5021-431e-ab68-8c10e4f8f0c57
106222lidocaine 20 MG/ML Topical CreamSCD091169e6-5021-431e-ab68-8c10e4f8f0c57
106222lidocaine 2 % Topical CreamSY091169e6-5021-431e-ab68-8c10e4f8f0c57

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61543-1601-1615431601011 TUBE in 1 BOX (61543-1601-1) > 28 g in 1 TUBE1 tube2019-03-150000-00-00NoNoCurrent