FDA.reportPublic FDA data

Lydexa 4.12%

Product NDC
59088-429
11-digit product format
590880429
Labeler code
59088
Product ID
59088-429_d9450f79-6270-8222-e053-2a95a90a0a48
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
PureTek Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2020-07-10
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
41.2 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
Lydexa 4.12%
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE41.2 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV13007Z41A
Rxcui1947197, 2474489

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-429-03Lydexa 4.12%28.3 g in 1 TUBECREAM28.35
59088-429-03Lydexa 4.12%1 in 1 CARTONCREAM15
59088-429-07Lydexa 4.12%85 g in 1 TUBECREAM855
59088-429-07Lydexa 4.12%1 in 1 CARTONCREAM15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-429-03GM - Gram59088-4296ae1b160-1535-417f-96c8-00867100ddb912020-09-14
59088-429-07GM - Gram59088-429109c2716-ba5d-4743-8afc-3898d37aaffa12022-04-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-429LYDEXA 4.12% (LIDOCAINE HYDROCHLORIDE) CREAM [PURETEK CORPORATION]5Current NDC, Legacy NDC, 4 package rows20220303_aa1c9d39-1283-8c6b-e053-2a95a90af5b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1947197lidocaine HCl 4.12 % Topical CreamPSNaa1c9d39-1283-8c6b-e053-2a95a90af5b55
2474489Lydexa 4.12 % Topical CreamPSNaa1c9d39-1283-8c6b-e053-2a95a90af5b55
2474489lidocaine hydrochloride 41.2 MG/ML Topical Cream [Lydexa]SBDaa1c9d39-1283-8c6b-e053-2a95a90af5b55
1947197lidocaine hydrochloride 41.2 MG/ML Topical CreamSCDaa1c9d39-1283-8c6b-e053-2a95a90af5b55
1947197lidocaine HCl 4.12 % Topical CreamSYaa1c9d39-1283-8c6b-e053-2a95a90af5b55
2474489Lydexa 4.12 % Topical CreamSYaa1c9d39-1283-8c6b-e053-2a95a90af5b55
2474489Lydexa 41.2 MG/ML Topical CreamSYaa1c9d39-1283-8c6b-e053-2a95a90af5b55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59088-429-03590880429031 TUBE in 1 CARTON (59088-429-03) / 28.3 g in 1 TUBE1 tube2020-07-100000-00-00NoNoCurrent
59088-429-07590880429071 TUBE in 1 CARTON (59088-429-07) / 85 g in 1 TUBE1 tube2022-03-020000-00-00NoNoCurrent