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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 23 · 441 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Flarestop Hemorrhoid LidocaineLIDOCAINEChelsea Pharmacceuticals LLCb8a589f7-7131-4807-9bcb-84af3078e2582026-09-10WarningsExact identifier
application number: M015
BCBCYC Numbing CreamLIDOCAINE 5% NUMBING CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.5ab36566-ba2f-06ef-e063-6394a90a71b52026-09-10WarningsExact identifier
application number: M015
5% Lidocaine 10g5% LIDOCAINEChongqing Mandongzi Technology Co., Ltd5b10530f-47cd-c4bd-e063-6294a90aaa0a2026-09-09WarningsExact identifier
application number: M015
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
application number: M015
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMCVS Pharmacy3167c918-a7d3-46a1-a85b-64f9c22916f22026-09-04WarningsExact identifier
application number: M015
Flushable Hemorrhoidal Medicated Wipes Maximum StrengthWITCH HAZELAmazon.com Services LLC41d756f3-e523-ed14-e063-6394a90ab8172026-09-03Warnings, Adverse reactionsExact identifier
application number: M015
Signature Care Medicated Wipes Hemorrhoidal Wipes with Witch HazelHEMORRHOIDAL WIPES WITH WITCH HAZELBetter Living Brands LLCadf26111-70ba-596c-e053-2995a90ac6f12026-09-03Warnings, Adverse reactionsExact identifier
application number: M015
up and up medicated wipes manixim strengthGENTLE HEMORRHOIDAL CARETarget Corporation271eab2b-ed13-39f1-e054-00144ff88e882026-09-03Warnings, Adverse reactionsExact identifier
application number: M015
KROGER MEDICATED WIPES HEMORRHOIDAL WIPE WITH WITCH HAZEL AND ALOEWITCH HAZEL CLOTHThe Kroger Co.48c1598d-6667-446f-ac90-10ab945d06172026-09-03Warnings, Adverse reactionsExact identifier
application number: M015
Rexall Medicated WipesHemorrhoidal wipe Hemorrhoidal wipes with witch hazelWITCH HAZELOld East Main Co.2055289d-962e-46a9-b371-b5bb93dd46b42026-09-03Warnings, Adverse reactionsExact identifier
application number: M015
Equate Hemorrhoidal Medicated WipesWITCH HAZELWalmart Inc.8d57f054-77dc-4205-85f1-b65dcfde677b2026-09-03Warnings, Adverse reactionsExact identifier
application number: M015
Lidocaine CreamLIDOCAINEInvaDerm Corporation5a7273d1-1dbc-420e-e063-6294a90a86292026-09-01WarningsExact identifier
application number: M015
Lidocaine PhenylephrineLIDOCAINE PHENYLEPHRINEYYBA CORP5a72a190-2129-411e-e063-6394a90a08c22026-09-01WarningsExact identifier
application number: M015
INICEI 5% LIDOCAINE Numbing Cream5% LIDOCAINE NUMBING CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5a65842f-27a1-268b-e063-6294a90a60542026-08-31WarningsExact identifier
application number: M015
AnievaLCLIDOCAINEBlackstone Products, LLCddaba14c-10de-44e2-ae13-9217e20cb48e2026-08-29WarningsExact identifier
application number: M015
Norms Hemorrhoid WipesWITCH HAZELTotally Normal Company5a1af50b-8d00-f589-e063-6394a90af86c2026-08-28WarningsExact identifier
application number: M015
LAIYINHE Numbing Cream Anorectal (Hemorrhoidal) CreamLIDOCAINEGuangzhou Hechuang Commercial Service Co.,Ltd.59f0fa16-5eb0-e6bb-e063-6294a90aacf52026-08-26WarningsExact identifier
application number: M015
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
Lidocaine Numbing CreamLIDOCAINEShanghai Chuangshi Medical Technology (Group) Co., Ltd.599b425a-0e96-76df-e063-6394a90a48ff2026-08-21WarningsExact 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