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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
98PI200987Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1432482Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
fb9ddde3-3f40-467e-8aff-26570144f0fcAvailable on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 22 · 436 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dude Hemorrhoidal WipesWITCH HAZELDude Productsfdf408ef-9392-a812-e053-6394a90a00172026-08-25WarningsExact identifier
application number: M015
Norms Medicated WipesWITCH HAZELTotally Normal Company3a78e109-3f7c-fb19-e063-6394a90ae78e2026-08-22WarningsExact identifier
application number: M015
NERANTE Numbing CreamLIDOCAINEGuangdong Quadrant Ecological Technology Co., Ltd.4dacd4f1-24d8-37ab-e063-6294a90a944d2026-08-21WarningsExact identifier
application number: M015
Lidocaine Numbing CreamLIDOCAINEShanghai Chuangshi Medical Technology (Group) Co., Ltd.599b425a-0e96-76df-e063-6394a90a48ff2026-08-21WarningsExact identifier
application number: M015
Numb520SprayLIDOCAINE, PHENYLEPHRINE HCLEbanel Laboratories, Inc.350f0e25-fbdc-c0c0-e063-6294a90a50a02026-08-20WarningsExact identifier
application number: M015
Flushable Hemorrhoidal Medicated Wipes Maximum StrengthWITCH HAZELAmazon.com Services LLC41d756f3-e523-ed14-e063-6394a90ab8172026-08-18Warnings, Adverse reactionsExact identifier
application number: M015
Gembooxt Topical Numbing CreamLIDOCAINEGuangdong Quadrant Ecological Technology Co., Ltd.49951a3e-3b62-3d66-e063-6294a90a93602026-08-12WarningsExact identifier
application number: M015
NumbMD Lidocaine Cream Anorectal(hemorrhoidal)LIDOCAINE 5%EveryMarket Inc52379055-d017-4d98-e063-6294a90a196c2026-08-12WarningsExact identifier
application number: M015
Nupharmisto NumbMD Lidocaine CreamLIDOCAINE 5%EveryMarket Inc52369a41-820d-cd7a-e063-6394a90ac6d12026-08-12WarningsExact identifier
application number: M015
Nupharmisto NumbMD Lidocaine CreamLIDOCAINE 5%EveryMarket Inc51d370b4-1c34-d203-e063-6394a90a80b12026-08-12WarningsExact identifier
application number: M015
Nupharmisto NumbMD 5% Lidocaine creamLIDOCAINE 5%EveryMarket Inc507d0c2c-9517-40f8-e063-6394a90a19962026-08-12WarningsExact identifier
application number: M015
Nupharmisto NumbMD LIDOCAINE cream anorectal (hemorrhoidal)LIDOCAINE CREAM ANORECTALEveryMarket Inc483d81a3-7493-3391-e063-6394a90a2e3d2026-08-12WarningsExact identifier
application number: M015
Numbing CreamLIDOCAINE100 KARMA INC35b5ba9d-da1d-55d6-e063-6294a90a5fa82026-08-12WarningsExact identifier
application number: M015
Treatonic hemorrhoid treatment5% LIDOCAINE100 KARMA INC41442fa7-c511-07ca-e063-6294a90a39922026-08-12WarningsExact identifier
application number: M015
Lidocaine numbing cream5% LIDOCAINE100 KARMA INC47380721-6633-4a50-e063-6394a90aca942026-08-12WarningsExact identifier
application number: M015
Treatonic 5% Lidocaine Cream5% LIDOCAINE CREAM100 KARMA INC47dc7630-9a74-1989-e063-6294a90a50bb2026-08-12WarningsExact identifier
application number: M015
Treatonic 5% Lidocaine Cream5% LIDOCAINE CREAM100 KARMA INC49e6b69f-bd6e-b415-e063-6394a90a8e652026-08-12WarningsExact identifier
application number: M015
Gniby LIDOCAINE ANORECTAL HEMORRHOIDAL NumbingLIDOCAINEPutian Licheng District Zhijiancheng Trading Co., Ltd.4a7be9eb-5e57-90e8-e063-6394a90aad9e2026-08-08WarningsExact identifier
application number: M015
THE SOLU TIONLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE HYDROCHLORIDESCALP TECH INC58793581-8826-9a74-e063-6294a90a24652026-08-06WarningsExact identifier
application number: M015
Lidocaine Numbing CreamLIDOCAINEGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.5457b3d7-e6b6-34a7-e063-6394a90aa2402026-08-03WarningsExact identifier
application number: M015

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