FDA.reportPublic FDA data

Lidozen

Product NDC
71205-348
11-digit product format
712050348
Labeler code
71205
Product ID
71205-348_f687fe54-1e59-45c2-859f-cb3279ed259d
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE, MENTHOL
Dosage form
PATCH
Route
TOPICAL
Labeler
Proficient Rx LP
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-09-16
Substance
LIDOCAINE; MENTHOL, UNSPECIFIED FORM
Active strength
40; 10 mg/g; 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
Lidozen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE40 mg/g
MENTHOL, UNSPECIFIED FORM10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii98PI200987, L7T10EIP3A
Rxcui1249758, 2201504

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
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
71205-348-05Lidozen1 g in 1 PATCHPATCH16
71205-348-05Lidozen5 in 1 BOXPATCH56
71205-348-15Lidozen1 g in 1 PATCHPATCH16
71205-348-15Lidozen15 in 1 BOXPATCH156
71205-348-30Lidozen30 in 1 BOXPATCH306
71205-348-30Lidozen1 g in 1 PATCHPATCH16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-348-05EA - Each71205-34887096a05-d1bb-4561-b1f0-8e69f2c0fd5012021-09-07
71205-348-15EA - Each71205-348e3618ca9-5cf7-4e6b-ab05-6787ea0d814a12022-03-09
71205-348-30EA - Each71205-348ba0b5e5c-6ca3-4489-8c33-04a255109ca612020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-348LIDOZEN (LIDOCAINE, MENTHOL) PATCH [PROFICIENT RX LP]6Current NDC, Legacy NDC, 6 package rows20231207_488d665c-a4fe-4a69-bab3-34b2347f4b05.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1249758lidocaine 4 % / menthol 1 % Medicated PatchPSN488d665c-a4fe-4a69-bab3-34b2347f4b056
2201504Lidozen 4 % / 1 % Medicated PatchPSN488d665c-a4fe-4a69-bab3-34b2347f4b056
2201504lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated Patch [Lidozen]SBD488d665c-a4fe-4a69-bab3-34b2347f4b056
1249758lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCD488d665c-a4fe-4a69-bab3-34b2347f4b056
1249758lidocaine 4 % / menthol 1 % Medicated PatchSY488d665c-a4fe-4a69-bab3-34b2347f4b056
2201504Lidozen (lidocaine 4 % / menthol 1 % ) Medicated PatchSY488d665c-a4fe-4a69-bab3-34b2347f4b056

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-348-05712050348055 PATCH in 1 BOX (71205-348-05) / 1 g in 1 PATCH5 patch2021-08-240000-00-00NoNoCurrent
71205-348-157120503481515 PATCH in 1 BOX (71205-348-15) / 1 g in 1 PATCH15 patch2021-08-240000-00-00NoNoCurrent
71205-348-307120503483030 PATCH in 1 BOX (71205-348-30) / 1 g in 1 PATCH30 patch2019-11-010000-00-00NoNoCurrent