DermacinRx Lidotral

Product NDC
59088-371
11-digit product format
590880371
Labeler code
59088
Product ID
59088-371_36a4cb7d-d1e8-4056-8344-c9f110820fcc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
PureTek Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2015-12-03
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
38.8 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
DermacinRx Lidotral
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE38.8 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
1723991Internal RxNorm lookup
1723996Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
23efec58-67cc-418d-85f5-7ef156443cbfAvailable on FDA.report

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
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
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
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
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
59088-371-07DermacinRx Lidotral1 in 1 CARTONCREAM12
59088-371-07DermacinRx Lidotral85 g in 1 TUBECREAM852

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-371-07GM - Gram59088-371b492bf4c-65d2-454c-a06e-b6728d1de17c12016-01-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-371DERMACINRX LIDOTRAL (LIDOCAINE HYDROCHLORIDE) CREAM [PURETEK CORPORATION]2Current NDC, Legacy NDC, 2 package rows20190205_23efec58-67cc-418d-85f5-7ef156443cbf.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
DermacinRx LidotralLIDOCAINE HYDROCHLORIDEPureTek Corporation23efec58-67cc-418d-85f5-7ef156443cbf2019-02-04Warnings, Adverse reactionsExact identifier
ndc (product): 59088-371

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1723991lidocaine HCl 3.88 % Topical CreamPSN23efec58-67cc-418d-85f5-7ef156443cbf2
1723996Lidotral 3.88 % Topical CreamPSN23efec58-67cc-418d-85f5-7ef156443cbf2
1723996lidocaine hydrochloride 38.8 MG/ML Topical Cream [Lidotral]SBD23efec58-67cc-418d-85f5-7ef156443cbf2
1723991lidocaine hydrochloride 38.8 MG/ML Topical CreamSCD23efec58-67cc-418d-85f5-7ef156443cbf2
1723991lidocaine hydrochloride 3.88 % Topical CreamSY23efec58-67cc-418d-85f5-7ef156443cbf2
1723996Lidotral 3.88 % Topical CreamSY23efec58-67cc-418d-85f5-7ef156443cbf2
1723996Lidotral 38.8 MG/ML Topical CreamSY23efec58-67cc-418d-85f5-7ef156443cbf2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59088-371-07590880371071 TUBE in 1 CARTON (59088-371-07) / 85 g in 1 TUBE1 tube2015-12-030000-00-00NoNoCurrent