FDA.reportPublic FDA data

LMX4

Product NDC
0496-0882
11-digit product format
004960882
Labeler code
0496
Product ID
0496-0882_459c9507-ea18-81b1-e063-6394a90a3db4
Type
HUMAN OTC DRUG
Nonproprietary name
lidocaine
Dosage form
CREAM
Route
TOPICAL
Labeler
Ferndale Laboratories, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-01-03
Substance
LIDOCAINE
Active strength
40 mg/g
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
LMX4
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE40 mg/g

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1421893Internal RxNorm lookup
1422103Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f0e7c92f-8b0b-4045-b659-af9f6e81260fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0496-0882-05LMX45 g in 1 TUBECREAM56
0496-0882-06LMX45 in 1 CARTONCREAM56
0496-0882-07LMX45 in 1 BOXCREAM56
0496-0882-15LMX415 g in 1 TUBECREAM156
0496-0882-30LMX430 g in 1 TUBECREAM306
0496-0882-71LMX41 in 1 BOXCREAM16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0496-0882-05GM - Gram0496-0882c8cc6767-ae03-48b9-a6e5-dbbbcb67f3ce12021-07-15
0496-0882-06GM - Gram0496-088222ebe846-b69c-48b8-b5ce-be3599d1376b12012-07-24
0496-0882-07EA - Each0496-08829a795358-5f11-441b-b27d-ef3adcb2e57412012-07-24
0496-0882-15GM - Gram0496-08827da3a277-b0cc-4ca0-b933-24f121dd0d0812012-07-24
0496-0882-30GM - Gram0496-088206d35deb-53ef-4057-83b7-5ece6b46a5fe12012-07-24
0496-0882-71EA - Each0496-088254d93ce4-7bf8-4116-be6f-74ac7102655b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINEACTIVE INGREDIENT98PI200987LMX4 (LIDOCAINE) CREAM [FERNDALE LABORATORIES, INC.]2
LIDOCAINEACTIVE MOIETY98PI200987LMX4 (LIDOCAINE) CREAM [FERNDALE LABORATORIES, INC.]2
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0LMX4 (LIDOCAINE) CREAM [FERNDALE LABORATORIES, INC.]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHLMX4 (LIDOCAINE) CREAM [FERNDALE LABORATORIES, INC.]2
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27ELMX4 (LIDOCAINE) CREAM [FERNDALE LABORATORIES, INC.]2
CHOLESTEROLINACTIVE INGREDIENT97C5T2UQ7JLMX4 (LIDOCAINE) CREAM [FERNDALE LABORATORIES, INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLMX4 (LIDOCAINE) CREAM [FERNDALE LABORATORIES, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LMX4 (LIDOCAINE) CREAM [FERNDALE LABORATORIES, INC.]2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKLMX4 (LIDOCAINE) CREAM [FERNDALE LABORATORIES, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RLMX4 (LIDOCAINE) CREAM [FERNDALE LABORATORIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0496-0882LMX4 (LIDOCAINE) CREAM [FERNDALE LABORATORIES, INC.]5Current NDC, Legacy NDC, 6 package rows20241220_f0e7c92f-8b0b-4045-b659-af9f6e81260f.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 17 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MyDerm Aloe and LidocaineLIDOCAINEMedline Industriesfdfd4388-cd27-467b-959b-249a49ea5cf62026-05-26WarningsExact identifier
application number: M017
MyDerm Aloe and LidocaineLIDOCAINEInspec Solutions LLC.4939c663-a876-4527-822a-df02964fa6942026-05-26WarningsExact identifier
application number: M017
Lidocaine Menthol Pain ReliefLIDOCAINE, MENTHOLAmerisource Bergen94039190-dde3-4d8e-873a-79abd3f6208b2026-05-26WarningsExact identifier
application number: M017
topcare hydrocortisoneHYDROCORTISONETopco Associates LLC858053a0-d888-4bb9-b94e-503bcf3864cb2026-05-21WarningsExact identifier
application number: M017
Arthritis Pain Relief CreamHISTAMINE DIHYDROCHLORIDESombra Cosmetics Inc.523333ee-eccd-bcf7-e063-6394a90aea602026-05-21WarningsExact identifier
application number: M017
North Star Nutritionals Soothanol X3 Pain Relieving DropsMENTHOLNEWMARKET HEALTH PRODUCTS, LLC068343b8-0435-40d0-846c-9d8624e8b6c42026-05-21WarningsExact identifier
application number: M017
DO ME DELAYLIDOCAINE HCLProdigy Media Inc5255ee85-6f29-0776-e063-6394a90a525b2026-05-21WarningsExact identifier
application number: M017
Australian Dream Back PainHISTAMINE DIHYDROCHLORIDESombra Cosmetics Inc.5256a63e-e6da-84c1-e063-6294a90a8dff2026-05-21WarningsExact identifier
application number: M017
SINSIN HANBANG FLEXCAMPHOR, MENTHOLSinsin Pharmaceutical co., ltd.525c5d18-bfc1-3002-e063-6394a90a5b1d2026-05-21WarningsExact identifier
application number: M017
LidoPro PatchLIDOCAINE, MENTHOL, AND METHYL SALICYLATEPreferred Pharmaceuticals Inc.6c9a076e-6316-427b-9ce6-c8fe2d3888372026-05-21WarningsExact identifier
application number: M017
Medi-First Capsaicin CreamCAPSAICINUnifirst First Aid Corporation49eb807b-fa31-3d84-e063-6394a90acfcf2026-05-20WarningsExact identifier
application number: M017
Biofreeze Triple Target Roll-OnCAMPHOR, CAPSAICIN, MENTHOLReckitt Benckiser LLC5089c088-3026-233a-e063-6394a90a93b62026-05-19WarningsExact identifier
application number: M017
Lidocaine Pain Relief PatchLIDOCAINEGERI-CARE PHARMACEUTICAL CORP522f1521-f9f2-4c26-e063-6394a90a9e052026-05-19WarningsExact identifier
application number: M017
Easment 0.1% Capsaicin Roll onCAPSAICIN 0.1%Easment LLC521212d6-57fd-4a7a-e063-6294a90a2a182026-05-18WarningsExact identifier
application number: M017
Burn ReliefLIDOCAINEWALMART INC.15af4557-4baf-c177-e063-6294a90a7a5b2026-05-18WarningsExact identifier
application number: M017
Blistex Maximum Hydration LipCAMPHOR (SYNTHETIC), DIMETHICONE, UNSPECIFIED, MENTHOL, UNSPECIFIED FORM, AND PHENOLBlistex Inc.fed223bc-edf3-46eb-b678-acb906f9ef112026-05-18WarningsExact identifier
application number: M017
Tiger BalmCAMPHOR (SYNTHETIC), MENTHOL, AND CAPSICUMHaw Par Healthcare Ltd.5066dc10-e4d5-49e9-9a5f-0ac220cfbf282026-05-18WarningsExact identifier
application number: M017
Deep Blue MiniMENTHOLdoTERRA International, LLC51dd58a8-1fd5-9cd7-e063-6394a90a1f722026-05-15WarningsExact identifier
application number: M017
Biofreeze Overnight GelMENTHOLReckitt Benckiser LLCf5c8c08b-c7c0-f84d-e053-2a95a90add152026-05-15WarningsExact identifier
application number: M017
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC00bba5d2-b0e0-701c-e063-6294a90a57412026-05-15WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1422103L-M-X-4 4 % Topical CreamPSNf0e7c92f-8b0b-4045-b659-af9f6e81260f6
1421893lidocaine 4 % Topical CreamPSNf0e7c92f-8b0b-4045-b659-af9f6e81260f6
1422103lidocaine 40 MG/ML Topical Cream [LMX]SBDf0e7c92f-8b0b-4045-b659-af9f6e81260f6
1421893lidocaine 40 MG/ML Topical CreamSCDf0e7c92f-8b0b-4045-b659-af9f6e81260f6
1422103L-M-X-4 4 % Topical CreamSYf0e7c92f-8b0b-4045-b659-af9f6e81260f6
1422103L-M-X-4 40 MG/ML Topical CreamSYf0e7c92f-8b0b-4045-b659-af9f6e81260f6
1421893lidocaine 4 % Topical CreamSYf0e7c92f-8b0b-4045-b659-af9f6e81260f6
1422103LMX 40 MG/ML Topical CreamSYf0e7c92f-8b0b-4045-b659-af9f6e81260f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0496-0882-05004960882055 g in 1 TUBE (0496-0882-05) 5 g2011-01-030000-00-00NoNoCurrent
0496-0882-06004960882065 TUBE in 1 CARTON (0496-0882-06) / 5 g in 1 TUBE (0496-0882-05) 5 tube2011-01-030000-00-00NoNoCurrent
0496-0882-07004960882075 TUBE in 1 BOX (0496-0882-07) / 5 g in 1 TUBE (0496-0882-05) 5 tube2011-01-030000-00-00NoNoCurrent
0496-0882-150049608821515 g in 1 TUBE (0496-0882-15) 15 g2011-01-030000-00-00NoNoCurrent
0496-0882-300049608823030 g in 1 TUBE (0496-0882-30) 30 g2011-01-030000-00-00NoNoCurrent
0496-0882-71004960882711 TUBE in 1 BOX (0496-0882-71) / 30 g in 1 TUBE (0496-0882-30) 1 tube2011-01-030000-00-00NoNoCurrent