Lydexa 4.12%

Product NDC
59088-429
Requested package NDC
59088-429-07
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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V13007Z41AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1947197Internal RxNorm lookup
2474489Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
aa1c9d39-1283-8c6b-e053-2a95a90af5b5Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lydexa 4.12%LIDOCAINE HYDROCHLORIDEPureTek Corporationaa1c9d39-1283-8c6b-e053-2a95a90af5b52022-03-02Warnings, Adverse reactionsExact identifier
ndc (package): 59088-429-07
ndc (product): 59088-429
ndc11 (package): 59088042907

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
59088-429-07590880429071 TUBE in 1 CARTON (59088-429-07) / 85 g in 1 TUBE1 tube2022-03-020000-00-00NoNoCurrent