FDA.reportPublic FDA data

Lidonexe

Product NDC
69329-002
11-digit product format
693290002
Labeler code
69329
Product ID
69329-002_081c276b-f716-081e-e054-00144ff88e88
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE, MENTHOL
Dosage form
PATCH
Route
TOPICAL
Labeler
Patchwerx Labs, Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-11-10
Marketing end
0000-00-00
Substance
LIDOCAINE HYDROCHLORIDE; MENTHOL
Active strength
4 g/100g; g/100g
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69329-002-052020-01-31C16284748780-19d75b9d0-e9ec-f424-e053-dadaa90a57ceLidonexe Patch
69329-002-252020-01-31C16284748780-19d75b9d0-e9ec-f424-e053-dadaa90a57ceLidonexe Patch

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69329-002-05Lidonexe10 g in 1 PATCHPATCH101
69329-002-05Lidonexe5 in 1 BOXPATCH51
69329-002-25Lidonexe25 in 1 BOXPATCH251
69329-002-25Lidonexe10 g in 1 PATCHPATCH101

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41ALIDONEXE (LIDOCAINE, MENTHOL) PATCH [PATCHWERX LABS, INC.]1
MENTHOLACTIVE INGREDIENTL7T10EIP3ALIDONEXE (LIDOCAINE, MENTHOL) PATCH [PATCHWERX LABS, INC.]1
LIDOCAINEACTIVE MOIETY98PI200987LIDONEXE (LIDOCAINE, MENTHOL) PATCH [PATCHWERX LABS, INC.]1
MENTHOLACTIVE MOIETYL7T10EIP3ALIDONEXE (LIDOCAINE, MENTHOL) PATCH [PATCHWERX LABS, INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XLIDONEXE (LIDOCAINE, MENTHOL) PATCH [PATCHWERX LABS, INC.]1
ARNICA MONTANAINACTIVE INGREDIENTO80TY208ZWLIDONEXE (LIDOCAINE, MENTHOL) PATCH [PATCHWERX LABS, INC.]1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PLIDONEXE (LIDOCAINE, MENTHOL) PATCH [PATCHWERX LABS, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLIDONEXE (LIDOCAINE, MENTHOL) PATCH [PATCHWERX LABS, INC.]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MLIDONEXE (LIDOCAINE, MENTHOL) PATCH [PATCHWERX LABS, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLIDONEXE (LIDOCAINE, MENTHOL) PATCH [PATCHWERX LABS, INC.]1
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B0LIDONEXE (LIDOCAINE, MENTHOL) PATCH [PATCHWERX LABS, INC.]1
INDIAN FRANKINCENSEINACTIVE INGREDIENT4PW41QCO2MLIDONEXE (LIDOCAINE, MENTHOL) PATCH [PATCHWERX LABS, INC.]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSLIDONEXE (LIDOCAINE, MENTHOL) PATCH [PATCHWERX LABS, INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TLIDONEXE (LIDOCAINE, MENTHOL) PATCH [PATCHWERX LABS, INC.]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQLIDONEXE (LIDOCAINE, MENTHOL) PATCH [PATCHWERX LABS, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLIDONEXE (LIDOCAINE, MENTHOL) PATCH [PATCHWERX LABS, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLIDONEXE (LIDOCAINE, MENTHOL) PATCH [PATCHWERX LABS, INC.]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKLIDONEXE (LIDOCAINE, MENTHOL) PATCH [PATCHWERX LABS, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RLIDONEXE (LIDOCAINE, MENTHOL) PATCH [PATCHWERX LABS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69329-002LIDONEXE (LIDOCAINE, MENTHOL) PATCH [PATCHWERX LABS, INC.]1Legacy NDC, 4 package rows20141118_081c276b-f715-081e-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1373130lidocaine HCl 4 % / menthol 1 % Medicated PatchPSN081c276b-f715-081e-e054-00144ff88e881
1373130lidocaine hydrochloride 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCD081c276b-f715-081e-e054-00144ff88e881
1373130lidocaine HCl 4 % / menthol 1 % Medicated PatchSY081c276b-f715-081e-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
69329-002-056932900020510 g in 1 PATCH10 gHistorical
69329-002-256932900022525 in 1 BOXHistorical