FDA.reportPublic FDA data

Lidocore

Product NDC
82944-201
11-digit product format
829440201
Labeler code
82944
Product ID
82944-201_2d6b7108-88be-1e69-e063-6394a90aea69
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine
Dosage form
CREAM
Route
TOPICAL
Labeler
iON Pharma, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-09-03
Substance
LIDOCAINE HYDROCHLORIDE ANHYDROUS
Active strength
3.1 g/76.5g
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
Lidocore
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE ANHYDROUS3.1 g/76.5g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
EC2CNF7XFPInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1010895Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
204c3e50-1ac8-f442-e063-6294a90ae7b5Available on FDA.report

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
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
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
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82944-201-02Lidocore76.5 g in 1 BOTTLECREAM76.52
82944-201-02Lidocore1 in 1 CARTONCREAM12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82944-201-02GM - Gram82944-201dddac8aa-0362-4725-b6c5-6e1b8040d8e712025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82944-201LIDOCORE (LIDOCAINE) CREAM [ION PHARMA, LLC]2Current NDC, 2 package rows20250214_204c3e50-1ac8-f442-e063-6294a90ae7b5.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 35 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
5 Elementum Delay WipesBENZOCAINE DELAY WIPESMSVenturesGroup O440539b0-612b-3b41-e063-6294a90a1ddd2026-02-05WarningsExact identifier
application number: M017
COOLING PAIN RELIEFMENTHOL, CAMPHORCHEMCO CORPORATION4a156400-7001-d00d-e063-6294a90aa7142026-02-05WarningsExact identifier
application number: M017
burnreliefLIDOCAINE HCLPublix Super Markets, Inc.9660f5e1-d39e-4f86-bf96-dff0f3bb729d2026-02-05Warnings, Adverse reactionsExact identifier
application number: M017
Aloe Vera GelLIDOCAINE HCL, MENTHOLPublix Super Markets, Inc.fe442f1e-7045-481a-a501-d629bf568dfb2026-02-05Warnings, Adverse reactionsExact identifier
application number: M017
Care Lix Pain ReliefSALICYLIC ACIDACQUIRED B SCALE LLC65dffffd-ede1-45e2-aa91-bdd5df2df6a62026-02-05WarningsExact identifier
application number: M017
2.5% Menthol PAIN RELIEFMENTHOLNantong Health & Beyond Hygienic Products Inc.8075ba60-772c-4d1a-8584-722bb3e539be2026-02-05WarningsExact identifier
application number: M017
4% Menthol PAIN RELIEFMENTHOLNantong Health & Beyond Hygienic Products Inc.51ce716e-b9f3-4e64-8c8e-17520d40f1922026-02-05WarningsExact identifier
application number: M017
2.0% LIDOCAINE BURNLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.2b58058a-f350-4029-b039-117caf1c03732026-02-05WarningsExact identifier
application number: M017
4% MENTHOL COLD THERAPYMENTHOLNantong Health & Beyond Hygienic Products Inc.7acc7282-ef4f-41ec-b51d-a88dfed79bd72026-02-05WarningsExact identifier
application number: M017
Cooling GelPAIN RELIEF COOLING GELNeilMed Pharmaceuticals Inc.49fb637b-ecc5-1f9b-e063-6294a90ab41a2026-02-04WarningsExact identifier
application number: M017
Medicaine Sting and BiteBENZOCAINEDynarex Corporationb721607e-e36b-4691-a824-c8f520bd63862026-02-04WarningsExact identifier
application number: M017
HEATING PAIN RELIEFMETHYL SALICYLATE, MENTHOLCHEMCO CORPORATION4a05f02e-e882-2cb2-e063-6394a90ad3282026-02-04WarningsExact identifier
application number: M017
MENTHOL, CAMPHORMENTHOL, CAMPHORCHEMCO CORPORATION4a065965-43bd-e0e3-e063-6294a90ad76a2026-02-04WarningsExact identifier
application number: M017
Menthol plus Camphor Pain ReliefMENTHOL, CAMPHORVeridian Healthcare4a0969d3-1f06-3ba7-e063-6294a90a86272026-02-04WarningsExact identifier
application number: M017
Relief FlexMENTHOLBeone Co., Ltd.49e6f0ef-78fb-26fe-e063-6294a90a66552026-02-03WarningsExact identifier
application number: M017
NATURULZ ULTIMATE HEALINGCAPSAICINI SHAY COSMETICS INC436eac74-d07f-d718-e063-6394a90a86602026-02-03WarningsExact identifier
application number: M017
TheraCare Muscle and Join Pain Relieving CreamMENTHOL, METHYL SALICYLATEVeridian Healthcare18f9829e-c5f9-4253-e063-6394a90a70c62026-02-03WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONECVS PHARMACY, INC8b8cdb26-8e8f-4e95-9d83-d685c90afe012026-02-02WarningsExact identifier
application number: M017
Muscular BalmCAPSAICIN MENTHOL METHYL SALICYLATEEagle Indo Pharma, PT888f88fc-dcaf-93e5-e053-2a95a90a20e12026-02-02WarningsExact identifier
application number: M017
Wang Prom Green Balm by Wang PromWANG PROM WANG PROM GREEN BALM BY VENTURE GO LLCAMBIENCE FAMILY INC4a063898-16a4-695a-e063-6394a90adb932026-02-02WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010895lidocaine HCl 4 % Topical CreamPSN204c3e50-1ac8-f442-e063-6294a90ae7b52
1010895lidocaine hydrochloride 40 MG/ML Topical CreamSCD204c3e50-1ac8-f442-e063-6294a90ae7b52
1010895lidocaine hydrochloride 4 % Topical CreamSY204c3e50-1ac8-f442-e063-6294a90ae7b52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82944-201-02829440201021 BOTTLE in 1 CARTON (82944-201-02) / 76.5 g in 1 BOTTLE1 bottle2024-09-13NoNoCurrent