FDA.reportPublic FDA data

Ztlido

Product NDC
69557-111
11-digit product format
695570111
Labeler code
69557
Product ID
69557-111_25e03ec1-e3a9-2483-e063-6394a90ad2d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine
Dosage form
PATCH
Route
TOPICAL
Labeler
Scilex Pharmaceuticals Inc.
Application
NDA207962
Marketing category
NDA
Marketing start
2018-04-26
Substance
LIDOCAINE
Active strength
36 mg/1
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
Ztlido
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE36 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii98PI200987
Rxcui2001434, 2001439

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69557-111-01Ztlido1 in 1 POUCHPATCH126
69557-111-03Ztlido3 in 1 CARTONPATCH326
69557-111-03Ztlido1 in 1 POUCHPATCH126
69557-111-30Ztlido30 in 1 CARTONPATCH3026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69557-111-01EA - Each69557-111e95dcddb-7d67-47c7-b6c3-a2427a5fb42712018-10-11
69557-111-30EA - Each69557-111565c7d1f-de9c-4868-8b2b-86b460890c3812018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69557-111ZTLIDO (LIDOCAINE) PATCH [SCILEX PHARMACEUTICALS INC.]26Current NDC, Legacy NDC, 4 package rows20241105_a1b17507-4560-490d-a388-74e7fd7eaa5e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2001434lidocaine 1.8 % Topical SystemPSNa1b17507-4560-490d-a388-74e7fd7eaa5e26
2001439ZTlido 1.8 % Topical SystemPSNa1b17507-4560-490d-a388-74e7fd7eaa5e26
2001439lidocaine 0.018 MG/MG Medicated Patch [ZTlido]SBDa1b17507-4560-490d-a388-74e7fd7eaa5e26
2001434lidocaine 0.018 MG/MG Medicated PatchSCDa1b17507-4560-490d-a388-74e7fd7eaa5e26
2001434lidocaine 1.8 % Medicated PatchSYa1b17507-4560-490d-a388-74e7fd7eaa5e26
2001434lidocaine 1.8 % Topical SystemSYa1b17507-4560-490d-a388-74e7fd7eaa5e26
2001439ZTlido 1.8 % Medicated PatchSYa1b17507-4560-490d-a388-74e7fd7eaa5e26
2001439ZTlido 1.8 % Topical SystemSYa1b17507-4560-490d-a388-74e7fd7eaa5e26

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69557-111-01695570111011 in 1 POUCHHistorical
69557-111-03695570111033 POUCH in 1 CARTON (69557-111-03) / 1 PATCH in 1 POUCH3 pouch2018-04-260000-00-00YesNoCurrent
69557-111-306955701113030 POUCH in 1 CARTON (69557-111-30) / 1 PATCH in 1 POUCH (69557-111-01) 30 pouch2018-04-260000-00-00NoNoCurrent