FDA.reportPublic FDA data

Assured

Product NDC
55621-010
11-digit product format
556210010
Labeler code
55621
Product ID
55621-010_0884b4eb-7fc4-b2c7-e063-6294a90aa02e
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE HYDROCHLORIDE
Dosage form
GEL
Route
TOPICAL
Labeler
Zhejiang Jingwei Pharmaceutical Co., Ltd.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-10-30
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
2.5 g/100g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE2.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V13007Z41AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1009433Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ab25c47d-bbe6-4e2b-9e39-dd9f4da3ee8cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55621-010-01Assured1 in 1 BOXGEL14
55621-010-01Assured20 g in 1 TUBEGEL204

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41AASSURED (LIDOCAINE HYDROCHLORIDE) GEL [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]1
LIDOCAINEACTIVE MOIETY98PI200987ASSURED (LIDOCAINE HYDROCHLORIDE) GEL [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XASSURED (LIDOCAINE HYDROCHLORIDE) GEL [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]1
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT4Q93RCW27EASSURED (LIDOCAINE HYDROCHLORIDE) GEL [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXASSURED (LIDOCAINE HYDROCHLORIDE) GEL [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]1
MENTHOL, UNSPECIFIED FORMINACTIVE INGREDIENTL7T10EIP3AASSURED (LIDOCAINE HYDROCHLORIDE) GEL [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TASSURED (LIDOCAINE HYDROCHLORIDE) GEL [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AASSURED (LIDOCAINE HYDROCHLORIDE) GEL [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ASSURED (LIDOCAINE HYDROCHLORIDE) GEL [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHASSURED (LIDOCAINE HYDROCHLORIDE) GEL [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKASSURED (LIDOCAINE HYDROCHLORIDE) GEL [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]1
WATERINACTIVE INGREDIENT059QF0KO0RASSURED (LIDOCAINE HYDROCHLORIDE) GEL [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55621-010ASSURED (LIDOCAINE HYDROCHLORIDE) GEL [ZHEJIANG JINGWEI PHARMACEUTICAL CO., LTD.]4Current NDC, Legacy NDC, 2 package rows20231025_ab25c47d-bbe6-4e2b-9e39-dd9f4da3ee8c.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 67 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
StallionDELAY CREMENovelties by Nasswalk, Inc.0261ec88-8fe4-d5f8-e063-6294a90ab3d42025-11-10WarningsExact identifier
application number: M017
ANAL-ESEDESENSITIZERNovelties by Nasswalk, Inc.03b89eed-b433-a263-e063-6294a90a675b2025-11-10WarningsExact identifier
application number: M017
Instant ErectionULTIMATE ERECTION ENHANCERNovelties by Nasswalk, Inc.03a444f9-7052-0c38-e063-6294a90a4e562025-11-10WarningsExact identifier
application number: M017
STA-HARDDESENSITIZING LUBRICANTNovelties by Nasswalk, Inc.02ef794b-8e70-5c26-e063-6294a90a28d12025-11-10WarningsExact identifier
application number: M017
ANAL-ESEDESENSITIZERNovelties by Nasswalk, Inc.03a4a7ce-4cff-a608-e063-6294a90ad65d2025-11-10WarningsExact identifier
application number: M017
FOOTSPA PEDIALCOHOLCHEMCO CORPORATION04de4392-74f6-7df8-e063-6294a90ae3b12025-11-08WarningsExact identifier
application number: M017
Johnson and Johnson All Purpose First Aid KitACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLC5cdb47c5-7951-4279-8a05-0a3199d3dd452025-11-06WarningsExact identifier
application number: M017
Johnson and Johnson First Aid Travel Ready 80 CTACETAMINOPHEN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDEKenvue Brands LLCf388f105-48ba-4616-e053-2a95a90a00492025-11-06WarningsExact identifier
application number: M017
Johnson and Johnson First Aid All Purpose 160 CTACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDEKenvue Brands LLCf3933330-2550-4a88-e053-2a95a90a39972025-11-06WarningsExact identifier
application number: M017
Foot and Leg Pain ReliefLIDOCAINEPremier Brands of America Inc.42f23e2f-11c6-da49-e063-6294a90ac7202025-11-06WarningsExact identifier
application number: M017
HEALING TREE CALMING ANTI-ITCHHYDROCORTISONERenu Laboratories, LLCfc8bcde9-26e8-a35f-e053-6394a90a33002025-11-06WarningsExact identifier
application number: M017
Calamine PlusCALAMINE PLUS PRAMOXINE HCLChain Drug Marketing Association Inc1a3f8819-58cf-8923-e063-6394a90a37af2025-11-06WarningsExact identifier
application number: M017
Extra Strength Itch ReliefDIPHENHYDRAMINE HCL AND ZINC ACETATEChain Drug Marketing Association Inc1a2997bc-7741-e658-e063-6394a90af6fd2025-11-06WarningsExact identifier
application number: M017
Diphenhydramine HCl and Zinc AcetateEXTRA STRENGTH ITCH RELIEF CONTINUOUS SPRAYTopco Associates LLC8026c7dd-eb7b-ebea-e053-2991aa0a1b0f2025-11-06WarningsExact identifier
application number: M017
Diphenhydramine HCl and Zinc AcetateEXTRA STRENGTH ITCH RELIEFWalgreen Company6057b4ff-6adc-4688-893c-62d237d7d1ae2025-11-06WarningsExact identifier
application number: M017
BANPINGHUA Glucosamine Chondroitin PatchPEPPERMINT, CAMPHOR, BORNEOLHenan Lijitang Medical Technology Co., Ltd.42f8c2ae-50a2-2358-e063-6394a90a59792025-11-06WarningsExact identifier
application number: M017
PAINGELCAMPHOR, MENTHOLNACOR BUSINESS GROUP LLC42fa2397-b61a-3b16-e063-6294a90a5fed2025-11-06WarningsExact identifier
application number: M017
PAINGEL UNGUENTOCAMPHOR, MENTHOLNACOR BUSINESS GROUP LLC42fab525-b0a5-97fb-e063-6394a90aec6c2025-11-06WarningsExact identifier
application number: M017
PAINGEL ROLL-ONMENTHOLNACOR BUSINESS GROUP LLC42fb0bdf-8bbd-bbe3-e063-6294a90a656c2025-11-06WarningsExact identifier
application number: M017
CoolexaCAMPHOR, MENTHOL, METHYL SALICYLATERising Pharma Holdings, Inc.38839f29-d4ce-4684-a3c7-0bb4bf1ad5942025-11-06WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1009433lidocaine HCl 2.5 % Topical GelPSNab25c47d-bbe6-4e2b-9e39-dd9f4da3ee8c4
1009433lidocaine hydrochloride 0.025 MG/MG Topical GelSCDab25c47d-bbe6-4e2b-9e39-dd9f4da3ee8c4
1009433lidocaine hydrochloride 2.5 % Topical GelSYab25c47d-bbe6-4e2b-9e39-dd9f4da3ee8c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55621-010-01556210010011 TUBE in 1 BOX (55621-010-01) / 20 g in 1 TUBE1 tube2014-10-300000-00-00NoNoCurrent