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 74 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nufabrx Medicine Infused SocksCAPSAICINNufabrx LLC00d7d5bf-ee03-e73d-e063-6394a90a5d942025-10-15WarningsExact identifier
application number: M017
Nufabrx Medicine Infused Elbow SleeveCAPSAICINNufabrx LLC27ef3ef0-2f98-6672-e063-6294a90aeca42025-10-15WarningsExact identifier
application number: M017
Nufabrx Medicine Infused Wrist SleeveCAPSAICINNufabrx LLC22572cf9-fc0c-d327-e063-6394a90a21862025-10-15WarningsExact identifier
application number: M017
Antibacterial Lidocaine Wound GelBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEWALGREENSeff77965-dc7f-49af-e053-2995a90a1a972025-10-14WarningsExact identifier
application number: M017
Pleasure Balm Kama SutraBENZOCAINECosmetic Enterprises Ltdf370e3c4-65ca-4f3c-a5aa-70e198e681a22025-10-14WarningsExact identifier
application number: M017
Vanicream HC Anti-ItchHYDROCORTISONEPharmaceutical Specialties, Inc.28b06507-27a5-2cb1-e054-00144ff8d46c2025-10-14WarningsExact identifier
application number: M017
TrilogelLIDOCAINE HYDROCHLORIDETrifluent Pharma LLC22af7d63-6a56-4a38-a95b-0f88410b23cb2025-10-14WarningsExact identifier
application number: M017
PROINNATE Numbing CreamMENTHOLGuangzhou Haishi Biological Technology Co., Ltd.40c63645-8ed3-82b3-e063-6294a90a52672025-10-13WarningsExact identifier
application number: M017
CramergesicMENTHOL, METHYL SALICYLATEThe Hygenic Company, LLCd0ffde7a-6942-74fc-e053-2a95a90a484a2025-10-13WarningsExact identifier
application number: M017
TricylateMENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATETrifluent Pharma LLC4869b63a-e01e-4a79-a493-7a1b4d3e914b2025-10-13WarningsExact identifier
application number: M017
Doloflex Pain ReliefMENTHOL, METHYL SALICYLATEUnited Health & Beauty Corp32a830cc-04d3-102e-e063-6294a90a1cad2025-10-12WarningsExact identifier
application number: M017
Lidocaine Pain Relieving Gel-PatchLIDOCAINENanjing Anxing Medical Technology Co., Ltd.40c9b132-57ce-865e-e063-6394a90a20802025-10-10WarningsExact identifier
application number: M017
KinesysZINC OXIDEWilc Healthcare Inca32b44c3-eda0-48ea-95fc-250a2c2396ca2025-10-10WarningsExact identifier
application number: M017
Te-Fu Recovery MassageMENTHOL, METHYL SALICYLATEWasatch Product Development7bc2989f-dfb6-e8af-e053-2991aa0a0bf22025-10-10WarningsExact identifier
application number: M017
Anti-itchHYDROCORTISONEMedline Industries, LPb0947381-c0db-4253-ab40-3d45603ae65d2025-10-09WarningsExact identifier
application number: M017
Kalaya Pain ReliefMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corpe2452c4b-2548-497f-828b-5d960402522a2025-10-08WarningsExact identifier
application number: M017
Kalaya Pain Relief 6X with ArnicaPAIN RELIEF CREAMAvaria Health & Beauty Corp60198d2e-4de3-3fa0-e053-2a91aa0afaf72025-10-08WarningsExact identifier
application number: M017
KALAYA PAIN RELIEF 6X WITH ARNICA - Pain ReliefMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corp9b9b7cad-a5e2-4445-856b-4aa439d77a802025-10-08WarningsExact identifier
application number: M017
KALAYA FOAMING PAIN RELIEFMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corpd5021e6d-f29f-446b-874c-bdcabd9cf4f62025-10-08WarningsExact identifier
application number: M017
KALAYA EXTRA STRENGTH FOAMING PAIN RELIEFMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corpe0c9f22a-165a-4558-ba3c-8592f1bd00162025-10-08WarningsExact 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