FDA.reportPublic FDA data

Lidogel

Product NDC
80425-0372
Requested package NDC
80425-0372-1
11-digit product format
804250372
Labeler code
80425
Product ID
80425-0372_0f3e686b-dd79-7a14-e063-6394a90a472b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine HCl
Dosage form
GEL
Route
TOPICAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-01-18
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
28 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
Lidogel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE28 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
2562183Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0f3ea647-a593-017b-e063-6294a90a38caAvailable 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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
80425-0372-1Lidogel100 g in 1 TUBEGEL1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0372-1GM - Gram80425-0372d68c2a58-fd73-4661-bd9e-a189f591829812024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0372LIDOGEL (LIDOCAINE HCL) GEL [ADVANCED RX PHARMACY OF TENNESSEE, LLC]1Current NDC, 1 package rows20240119_0f3ea647-a593-017b-e063-6294a90a38ca.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
LidogelLIDOCAINE HCLAdvanced Rx Pharmacy of Tennessee, LLC0f3ea647-a593-017b-e063-6294a90a38ca2024-01-18Warnings, Adverse reactionsExact identifier
ndc (package): 80425-0372-1
ndc (product): 80425-0372
ndc11 (package): 80425037201

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2562183lidocaine HCl 2.8 % Topical GelPSN0f3ea647-a593-017b-e063-6294a90a38ca1
2562183lidocaine hydrochloride 0.028 MG/MG Topical GelSCD0f3ea647-a593-017b-e063-6294a90a38ca1
2562183lidocaine hydrochloride 2.8 % Topical GelSY0f3ea647-a593-017b-e063-6294a90a38ca1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0372-180425037201100 g in 1 TUBE (80425-0372-1) 100 g2023-01-18NoNoCurrent