FDA.reportPublic FDA data

Assured

Product NDC
55621-011
11-digit product format
556210011
Labeler code
55621
Product ID
55621-011_0884bc8d-70c2-80db-e063-6294a90a6582
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE
Dosage form
CREAM
Route
TOPICAL
Labeler
Zhejiang Jingwei Pharmaceutical Co., Ltd.
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-10-30
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Assured
Brand name suffix
Bikini Smooth Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE2 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii98PI200987
Rxcui1432482

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55621-011-01Assured Bikini Smooth Cream1 in 1 BOXCREAM14
55621-011-01Assured Bikini Smooth Cream28 g in 1 TUBECREAM284

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINEACTIVE INGREDIENT98PI200987ASSURED BIKINI SMOOTH CREAM (LIDOCAINE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]1
LIDOCAINEACTIVE MOIETY98PI200987ASSURED BIKINI SMOOTH CREAM (LIDOCAINE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MASSURED BIKINI SMOOTH CREAM (LIDOCAINE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XASSURED BIKINI SMOOTH CREAM (LIDOCAINE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]1
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT4Q93RCW27EASSURED BIKINI SMOOTH CREAM (LIDOCAINE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]1
ETHYLPARABENINACTIVE INGREDIENT14255EXE39ASSURED BIKINI SMOOTH CREAM (LIDOCAINE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXASSURED BIKINI SMOOTH CREAM (LIDOCAINE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]1
MALONDIALDEHYDEINACTIVE INGREDIENT4Y8F71G49QASSURED BIKINI SMOOTH CREAM (LIDOCAINE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]1
MENTHOL, UNSPECIFIED FORMINACTIVE INGREDIENTL7T10EIP3AASSURED BIKINI SMOOTH CREAM (LIDOCAINE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKASSURED BIKINI SMOOTH CREAM (LIDOCAINE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]1
WATERINACTIVE INGREDIENT059QF0KO0RASSURED BIKINI SMOOTH CREAM (LIDOCAINE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55621-011ASSURED BIKINI SMOOTH CREAM (LIDOCAINE) CREAM [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]4Current NDC, Legacy NDC, 2 package rows20231025_fb9ddde3-3f40-467e-8aff-26570144f0fc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1432482lidocaine HCl 2 % Topical CreamPSNfb9ddde3-3f40-467e-8aff-26570144f0fc4
1432482lidocaine hydrochloride 20 MG/ML Topical CreamSCDfb9ddde3-3f40-467e-8aff-26570144f0fc4
1432482lidocaine hydrochloride 2 % Topical CreamSYfb9ddde3-3f40-467e-8aff-26570144f0fc4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55621-011-01556210011011 TUBE in 1 BOX (55621-011-01) / 28 g in 1 TUBE1 tube2015-10-300000-00-00NoNoCurrent