FDA.reportPublic FDA data

Lidenza Patch

Product NDC
69329-017
11-digit product format
693290017
Labeler code
69329
Product ID
69329-017_07e9972b-b74c-4eb5-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
PATCH
Route
TOPICAL
Labeler
Patchwerx Labs, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2013-10-01
Marketing end
0000-00-00
Substance
LIDOCAINE HYDROCHLORIDE; MENTHOL
Active strength
4 g/100g; g/100g
Pharmacologic classes
Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE]
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
69329-017-152020-01-31C16284748780-19d75b9d0-0eb9-f424-e053-dadaa90a57ceLidenza Patch
69329-017-252020-01-31C16284748780-19d75b9d0-0eb9-f424-e053-dadaa90a57ceLidenza Patch

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69329-017-15Lidenza Patch100 g in 1 PACKAGEPATCH1001
69329-017-25Lidenza Patch100 g in 1 PACKAGEPATCH1001

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41ALIDENZA PATCH (LIDOCAINE HYDROCHLORIDE) PATCH [PATCHWERX LABS, INC.]1
MENTHOLACTIVE INGREDIENTL7T10EIP3ALIDENZA PATCH (LIDOCAINE HYDROCHLORIDE) PATCH [PATCHWERX LABS, INC.]1
LIDOCAINEACTIVE MOIETY98PI200987LIDENZA PATCH (LIDOCAINE HYDROCHLORIDE) PATCH [PATCHWERX LABS, INC.]1
MENTHOLACTIVE MOIETYL7T10EIP3ALIDENZA PATCH (LIDOCAINE HYDROCHLORIDE) PATCH [PATCHWERX LABS, INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XLIDENZA PATCH (LIDOCAINE HYDROCHLORIDE) PATCH [PATCHWERX LABS, INC.]1
ARNICA MONTANAINACTIVE INGREDIENTO80TY208ZWLIDENZA PATCH (LIDOCAINE HYDROCHLORIDE) PATCH [PATCHWERX LABS, INC.]1
BOSWELLIA SACRA WHOLEINACTIVE INGREDIENT8O600AZL0WLIDENZA PATCH (LIDOCAINE HYDROCHLORIDE) PATCH [PATCHWERX LABS, INC.]1
CARBOMER 1342INACTIVE INGREDIENT809Y72KV36LIDENZA PATCH (LIDOCAINE HYDROCHLORIDE) PATCH [PATCHWERX LABS, INC.]1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PLIDENZA PATCH (LIDOCAINE HYDROCHLORIDE) PATCH [PATCHWERX LABS, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDLIDENZA PATCH (LIDOCAINE HYDROCHLORIDE) PATCH [PATCHWERX LABS, INC.]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MLIDENZA PATCH (LIDOCAINE HYDROCHLORIDE) PATCH [PATCHWERX LABS, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLIDENZA PATCH (LIDOCAINE HYDROCHLORIDE) PATCH [PATCHWERX LABS, INC.]1
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B0LIDENZA PATCH (LIDOCAINE HYDROCHLORIDE) PATCH [PATCHWERX LABS, INC.]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSLIDENZA PATCH (LIDOCAINE HYDROCHLORIDE) PATCH [PATCHWERX LABS, INC.]1
PEG-8 GLYCERYL ISOSTEARATEINACTIVE INGREDIENT74QQ5X3KL1LIDENZA PATCH (LIDOCAINE HYDROCHLORIDE) PATCH [PATCHWERX LABS, INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TLIDENZA PATCH (LIDOCAINE HYDROCHLORIDE) PATCH [PATCHWERX LABS, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLIDENZA PATCH (LIDOCAINE HYDROCHLORIDE) PATCH [PATCHWERX LABS, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLIDENZA PATCH (LIDOCAINE HYDROCHLORIDE) PATCH [PATCHWERX LABS, INC.]1
TRIETHANOLAMINE BENZOATEINACTIVE INGREDIENTM3EN4GC19WLIDENZA PATCH (LIDOCAINE HYDROCHLORIDE) PATCH [PATCHWERX LABS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RLIDENZA PATCH (LIDOCAINE HYDROCHLORIDE) PATCH [PATCHWERX LABS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69329-017LIDENZA PATCH (LIDOCAINE HYDROCHLORIDE) PATCH [PATCHWERX LABS, INC.]1Legacy NDC, 2 package rows20141117_07e9972b-b74b-4eb5-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1373130lidocaine HCl 4 % / menthol 1 % Medicated PatchPSN07e9972b-b74b-4eb5-e054-00144ff88e881
1373130lidocaine hydrochloride 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCD07e9972b-b74b-4eb5-e054-00144ff88e881
1373130lidocaine HCl 4 % / menthol 1 % Medicated PatchSY07e9972b-b74b-4eb5-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
69329-017-1569329001715100 g in 1 PACKAGE100 gHistorical
69329-017-2569329001725100 g in 1 PACKAGE100 gHistorical