FDA.reportPublic FDA data

Lidozen

Product NDC
71574-300
11-digit product format
715740300
Labeler code
71574
Product ID
71574-300_09db59ea-79d1-56ef-e063-6294a90a0c4b
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE HYDROCHLORIDE, MENTHOL
Dosage form
GEL
Route
TOPICAL
Labeler
Village Pharma, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-07-22
Substance
LIDOCAINE HYDROCHLORIDE; MENTHOL
Active strength
40; 10 mg/mL; mg/mL
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
LIDOCAINE HYDROCHLORIDE40 mg/mL
MENTHOL10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A, L7T10EIP3A
Rxcui1373137, 1939340

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
71574-300-72Lidozen120 mL in 1 BOTTLEGEL1203
71574-300-72Lidozen1 in 1 BOXGEL13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71574-300-72ML - Milliliter71574-300222376ab-79df-474b-b2c7-7a9e9f567ca712017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71574-300LIDOZEN (LIDOCAINE HYDROCHLORIDE, MENTHOL) GEL [VILLAGE PHARMA, LLC]3Current NDC, Legacy NDC, 2 package rows20231112_55108ffd-d6a8-41de-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1373137lidocaine HCl 4 % / menthol 1 % Topical GelPSN1ebb45e5-4541-4c95-abe1-661ef763a6108
1939340LidozenGel 4 % / 1 % Topical GelPSN1ebb45e5-4541-4c95-abe1-661ef763a6108
1939340lidocaine hydrochloride 0.04 MG/MG / menthol 0.01 MG/MG Topical Gel [Lidozen]SBD1ebb45e5-4541-4c95-abe1-661ef763a6108
1373137lidocaine hydrochloride 0.04 MG/MG / menthol 0.01 MG/MG Topical GelSCD1ebb45e5-4541-4c95-abe1-661ef763a6108
1373137lidocaine hydrochloride 4 % / menthol 1 % Topical GelSY1ebb45e5-4541-4c95-abe1-661ef763a6108
1939340Lidozen 4 % / 1 % Topical GelSY1ebb45e5-4541-4c95-abe1-661ef763a6108
1939340LidozenGel 4 % / 1 % Topical GelSY1ebb45e5-4541-4c95-abe1-661ef763a6108
1373137lidocaine HCl 4 % / menthol 1 % Topical GelPSN55108ffd-d6a8-41de-e054-00144ff88e883
1939340LidozenGel 4 % / 1 % Topical GelPSN55108ffd-d6a8-41de-e054-00144ff88e883
1939340lidocaine hydrochloride 0.04 MG/MG / menthol 0.01 MG/MG Topical Gel [Lidozen]SBD55108ffd-d6a8-41de-e054-00144ff88e883
1373137lidocaine hydrochloride 0.04 MG/MG / menthol 0.01 MG/MG Topical GelSCD55108ffd-d6a8-41de-e054-00144ff88e883
1373137lidocaine hydrochloride 4 % / menthol 1 % Topical GelSY55108ffd-d6a8-41de-e054-00144ff88e883
1939340Lidozen 4 % / 1 % Topical GelSY55108ffd-d6a8-41de-e054-00144ff88e883
1939340LidozenGel 4 % / 1 % Topical GelSY55108ffd-d6a8-41de-e054-00144ff88e883

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71574-300-72715740300721 BOTTLE in 1 BOX (71574-300-72) / 120 mL in 1 BOTTLE1 bottle2017-07-220000-00-00NoNoCurrent