FDA.reportPublic FDA data

Lidozen Gel

Product NDC
71574-305
11-digit product format
715740305
Labeler code
71574
Product ID
71574-305_43ca4fac-caaa-43e7-9c15-1ec8c69893d5
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
2022-09-01
Substance
LIDOCAINE HYDROCHLORIDE; MENTHOL, UNSPECIFIED FORM
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lidozen Gel
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE40 mg/mL
MENTHOL, UNSPECIFIED FORM10 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
71574-305-72Lidozen Gel120 mL in 1 BOTTLEGEL1203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71574-305-72ML - Milliliter71574-30562f091e3-c2a0-4437-98f0-fbac2435b93012022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71574-305LIDOZEN GEL (LIDOCAINE HYDROCHLORIDE, MENTHOL) GEL [VILLAGE PHARMA LLC]2Current NDC, Legacy NDC, 1 package rows20231201_ffb7831f-4ca9-4d73-8303-e9cd90078982.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1373137lidocaine HCl 4 % / menthol 1 % Topical GelPSNffb7831f-4ca9-4d73-8303-e9cd900789823
1939340LidozenGel 4 % / 1 % Topical GelPSNffb7831f-4ca9-4d73-8303-e9cd900789823
1939340lidocaine hydrochloride 0.04 MG/MG / menthol 0.01 MG/MG Topical Gel [Lidozen]SBDffb7831f-4ca9-4d73-8303-e9cd900789823
1373137lidocaine hydrochloride 0.04 MG/MG / menthol 0.01 MG/MG Topical GelSCDffb7831f-4ca9-4d73-8303-e9cd900789823
1373137lidocaine hydrochloride 4 % / menthol 1 % Topical GelSYffb7831f-4ca9-4d73-8303-e9cd900789823
1939340Lidozen 4 % / 1 % Topical GelSYffb7831f-4ca9-4d73-8303-e9cd900789823
1939340LidozenGel 4 % / 1 % Topical GelSYffb7831f-4ca9-4d73-8303-e9cd900789823
1373137lidocaine HCl 4 % / menthol 1 % Topical GelPSN7c300dec-cefd-4b79-a948-a917b7708a042
1939340LidozenGel 4 % / 1 % Topical GelPSN7c300dec-cefd-4b79-a948-a917b7708a042
1939340lidocaine hydrochloride 0.04 MG/MG / menthol 0.01 MG/MG Topical Gel [Lidozen]SBD7c300dec-cefd-4b79-a948-a917b7708a042
1373137lidocaine hydrochloride 0.04 MG/MG / menthol 0.01 MG/MG Topical GelSCD7c300dec-cefd-4b79-a948-a917b7708a042
1373137lidocaine hydrochloride 4 % / menthol 1 % Topical GelSY7c300dec-cefd-4b79-a948-a917b7708a042
1939340Lidozen 4 % / 1 % Topical GelSY7c300dec-cefd-4b79-a948-a917b7708a042
1939340LidozenGel 4 % / 1 % Topical GelSY7c300dec-cefd-4b79-a948-a917b7708a042

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71574-305-7271574030572120 mL in 1 BOTTLE (71574-305-72) 120 ml2022-09-010000-00-00NoNoCurrent