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 28 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LIDOGUARDLIDOCAINE 4%ViolaCare, Inc.d8b021b6-cf71-4f7e-9d27-92d0982bd34f2026-03-25WarningsExact identifier
application number: M017
LactiGoMENTHOLLactiGo, Inc.4dda6ac4-d849-69a6-e063-6394a90a3c542026-03-25WarningsExact identifier
application number: M017
Alocane MaxLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEQuest Products LLC0a33f9a9-1fdc-7cdf-e063-6294a90adca12026-03-25WarningsExact identifier
application number: M017
EjaGuardLIDOCAINEMOLANSPACE INC475f64ef-d636-7e87-e063-6294a90ae32f2026-03-25WarningsExact identifier
application number: M017
Hydrocortisone 1%HYDROCORTISONEProStat First Aid4e53d29c-ed3c-f481-e063-6294a90a31812026-03-25WarningsExact identifier
application number: M017
Topicaine UltraTOPICAINE ULTRAOncora Pharma, LLCe052f718-700a-44e0-8770-65451b812ee12026-03-24WarningsExact identifier
application number: M017
Hot Pap CataplasmaMETHYL SALICYLATE, VANILLYL NONYLAMIDEMasaem Company4dbeda13-b198-0cf0-e063-6294a90a81802026-03-24WarningsExact identifier
application number: M017
Barmicil Anti-itchHYDROCORTISONEOPMX LLC850084c3-1dd4-eb8d-e053-2a91aa0a130b2026-03-24WarningsExact identifier
application number: M017
Jeil Hangbang Paff Soo S CataplasmaGLYCOL SALICYLATE, L-MENTHOLMasaem Company4dd040db-07cf-361a-e063-6394a90a80012026-03-24WarningsExact identifier
application number: M017
Zenol Double ActionMETHYL SALICYLATE, L-MENTHOLBA TRADE INC4da998fc-75a3-583f-e063-6394a90a59c72026-03-23WarningsExact identifier
application number: M017
Ultra Strength Topical Pain Relief CreamCAMPHOR, MENTHOL, METHYL SALICYLATEJ C UDEOZOR & SONS GLOBAL INDUSTRIES LTD4db9ae57-4ab4-8fe4-e063-6394a90a7e512026-03-23WarningsExact identifier
application number: M017
DR. SANA ALIVIO TOTAL ALIVIO TOTAL ROLL ONALIVIO TOTAL ROLL ONEVI LABS4da01338-8739-08a8-e063-6294a90ae1572026-03-22WarningsExact identifier
application number: M017
DR SANA ALIVIO TOTAL ALIVIO TOTALALIVIO TOTALEVI LABS4da1c3b8-9af2-6e9f-e063-6394a90a86ae2026-03-22WarningsExact identifier
application number: M017
SORE NO MOREMENTHOL CAMPHORSOMBRA COSMETICS INC.80d97c80-bdc0-4d5d-b6e2-86dfdb15d7bd2026-03-20WarningsExact identifier
application number: M017
CVS Health Antiseptic Wound WashLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDECVS Pharmacy53ac017a-eccb-3b24-e054-00144ff88e882026-03-20WarningsExact identifier
application number: M017
Tecnu Diphenhydramine HCl Pain Relieving Anti Itch Gel 2%ANTI ITCH GELWalgreens3d6e8c62-2fcc-51c2-e063-6394a90a33f72026-03-20WarningsExact identifier
application number: M017
ANIXIKE NumbingMENTHOL 5% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4d5c52d7-8e81-b62f-e063-6394a90ad03e2026-03-19WarningsExact identifier
application number: M017
SYLVIRENE NUMBINGMENTHOL 5% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4d47e8c7-d293-bf63-e063-6294a90a5fd92026-03-18WarningsExact identifier
application number: M017
Antibiotic and Pain ReliefNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLCf7aa9330-c47c-4d2f-b784-11b831d919d62026-03-18WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEBryant Ranch Prepack99726aa3-3b45-4175-8471-279419af54572026-03-18WarningsExact 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