FDA.reportPublic FDA data

LMX5

Product NDC
0496-0883
11-digit product format
004960883
Labeler code
0496
Product ID
0496-0883_459d6bfe-7674-6302-e063-6394a90ab994
Type
HUMAN OTC DRUG
Nonproprietary name
lidocaine
Dosage form
CREAM
Route
TOPICAL
Labeler
Ferndale Laboratories, Inc.
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2003-10-01
Substance
LIDOCAINE
Active strength
50 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

Additional Listing Data#

Finished product
Yes
Brand name base
LMX5
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE50 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii98PI200987
Rxcui1366789, 1422107

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0496-0883-15LMX515 g in 1 TUBECREAM155
0496-0883-30LMX530 g in 1 TUBECREAM305
0496-0883-97LMX51 g in 1 POUCHCREAM15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0496-0883-15GM - Gram0496-0883631a04a5-c1f5-4442-9a18-21d23db6391412012-07-24
0496-0883-30GM - Gram0496-0883bda2c4f5-5a92-4a37-a3f2-ae2ec5b42e6d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINEACTIVE INGREDIENT98PI200987LMX5 (LIDOCAINE) CREAM [FERNDALE LABORATORIES, INC.]2
LIDOCAINEACTIVE MOIETY98PI200987LMX5 (LIDOCAINE) CREAM [FERNDALE LABORATORIES, INC.]2
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0LMX5 (LIDOCAINE) CREAM [FERNDALE LABORATORIES, INC.]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHLMX5 (LIDOCAINE) CREAM [FERNDALE LABORATORIES, INC.]2
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27ELMX5 (LIDOCAINE) CREAM [FERNDALE LABORATORIES, INC.]2
CHOLESTEROLINACTIVE INGREDIENT97C5T2UQ7JLMX5 (LIDOCAINE) CREAM [FERNDALE LABORATORIES, INC.]2
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSLMX5 (LIDOCAINE) CREAM [FERNDALE LABORATORIES, INC.]2
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62LMX5 (LIDOCAINE) CREAM [FERNDALE LABORATORIES, INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLMX5 (LIDOCAINE) CREAM [FERNDALE LABORATORIES, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3LMX5 (LIDOCAINE) CREAM [FERNDALE LABORATORIES, INC.]2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKLMX5 (LIDOCAINE) CREAM [FERNDALE LABORATORIES, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RLMX5 (LIDOCAINE) CREAM [FERNDALE LABORATORIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0496-0883LMX5 (LIDOCAINE) CREAM [FERNDALE LABORATORIES, INC.]4Current NDC, Legacy NDC, 3 package rows20241219_34f8ed6b-4a52-4a99-9c1b-254196dc29b0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1422107L-M-X-5 5 % Rectal CreamPSN34f8ed6b-4a52-4a99-9c1b-254196dc29b05
1366789lidocaine 5 % Rectal CreamPSN34f8ed6b-4a52-4a99-9c1b-254196dc29b05
1422107lidocaine 50 MG/ML Rectal Cream [LMX]SBD34f8ed6b-4a52-4a99-9c1b-254196dc29b05
1366789lidocaine 50 MG/ML Rectal CreamSCD34f8ed6b-4a52-4a99-9c1b-254196dc29b05
1422107L-M-X-5 5 % Rectal CreamSY34f8ed6b-4a52-4a99-9c1b-254196dc29b05
1422107L-M-X-5 50 MG/ML Rectal CreamSY34f8ed6b-4a52-4a99-9c1b-254196dc29b05
1366789lidocaine 5 % Rectal CreamSY34f8ed6b-4a52-4a99-9c1b-254196dc29b05
1422107LMX 50 MG/ML Rectal CreamSY34f8ed6b-4a52-4a99-9c1b-254196dc29b05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0496-0883-150049608831515 g in 1 TUBE (0496-0883-15) 15 g2003-10-010000-00-00NoNoCurrent
0496-0883-300049608833030 g in 1 TUBE (0496-0883-30) 30 g2003-10-010000-00-00NoNoCurrent
0496-0883-97004960883971 g in 1 POUCH (0496-0883-97) 1 g2003-10-010000-00-00YesNoCurrent