FDA.reportPublic FDA data

Lidocaine 5% Gel

Product NDC
59088-247
11-digit product format
590880247
Labeler code
59088
Product ID
59088-247_3f30281e-eecd-dad9-e063-6394a90a5d0e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine HCl 5%
Dosage form
GEL
Route
TOPICAL
Labeler
Puretek Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-09-19
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
50 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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine 5% GelLIDOCAINE HCL 5%Puretek Corporation3f2f0f2b-2759-c010-e063-6394a90a8e5e2025-09-19Warnings, Adverse reactionsExact identifier
ndc (product): 59088-247

Additional Listing Data#

Finished product
Yes
Brand name base
Lidocaine 5% Gel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE50 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1010057Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3f2f0f2b-2759-c010-e063-6394a90a8e5eAvailable 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
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
59088-247-07Lidocaine 5% Gel85 g in 1 TUBEGEL851

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-247-07GM - Gram59088-247c11231ab-b7dd-4a17-856e-221a7382c9a812025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1010057lidocaine HCl 5 % Topical GelPSN3f2f0f2b-2759-c010-e063-6394a90a8e5e1
1010057lidocaine hydrochloride 0.05 MG/MG Topical GelSCD3f2f0f2b-2759-c010-e063-6394a90a8e5e1
1010057lidocaine hydrochloride 5 % Topical GelSY3f2f0f2b-2759-c010-e063-6394a90a8e5e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59088-247-075908802470785 g in 1 TUBE (59088-247-07) 85 g2025-09-19NoNoCurrent