FDA.reportPublic FDA data

Lido Rx

Product NDC
35781-0300
Requested package NDC
35781-0300-1
11-digit product format
357810300
Labeler code
35781
Product ID
35781-0300_ea39df29-909f-0f1d-e053-2995a90aa417
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine
Dosage form
GEL
Route
TOPICAL
Labeler
Gensco Laboratories, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2013-03-01
Marketing end
0000-00-00
Substance
LIDOCAINE
Active strength
30 mg/g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage35781-030035781-0300-1IInactivated by FDA2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 16 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…

Reported adverse events (FAERS/openFDA)#

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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
35781-0300-12023-07-28LiDORx These highlights do not include all the information needed to use Lido see full prescribing information for safety and efficacy data and Initial U.S. Approval
35781-0300-32023-07-28LiDORx These highlights do not include all the information needed to use Lido see full prescribing information for safety and efficacy data and Initial U.S. Approval
35781-0300-92023-07-28LiDORx These highlights do not include all the information needed to use Lido see full prescribing information for safety and efficacy data and Initial U.S. Approval
35781-0300-12022-10-05LiDORx These highlights do not include all the information needed to use Lido see full prescribing information for safety and efficacy data and Initial U.S. Approval
35781-0300-32022-10-05LiDORx These highlights do not include all the information needed to use Lido see full prescribing information for safety and efficacy data and Initial U.S. Approval
35781-0300-92022-10-05LiDORx These highlights do not include all the information needed to use Lido see full prescribing information for safety and efficacy data and Initial U.S. Approval
35781-0300-12022-07-29LiDORx These highlights do not include all the information needed to use Lido see full prescribing information for safety and efficacy data and Initial U.S. Approval
35781-0300-32022-07-29LiDORx These highlights do not include all the information needed to use Lido see full prescribing information for safety and efficacy data and Initial U.S. Approval
35781-0300-92022-07-29LiDORx These highlights do not include all the information needed to use Lido see full prescribing information for safety and efficacy data and Initial U.S. Approval
35781-0300-12020-09-14LiDORx These highlights do not include all the information needed to use Lido see full prescribing information for safety and efficacy data and Initial U.S. Approval
35781-0300-32020-09-14LiDORx These highlights do not include all the information needed to use Lido see full prescribing information for safety and efficacy data and Initial U.S. Approval
35781-0300-92020-09-14LiDORx These highlights do not include all the information needed to use Lido see full prescribing information for safety and efficacy data and Initial U.S. Approval
35781-0300-12020-07-22LiDORx These highlights do not include all the information needed to use Lido see full prescribing information for safety and efficacy data and Initial U.S. Approval
35781-0300-32020-07-22LiDORx These highlights do not include all the information needed to use Lido see full prescribing information for safety and efficacy data and Initial U.S. Approval
35781-0300-92020-07-22LiDORx These highlights do not include all the information needed to use Lido see full prescribing information for safety and efficacy data and Initial U.S. Approval

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35781-0300-1Lido Rx9.5 g in 1 TUBEGEL9.511
35781-0300-1Lido Rx1 in 1 CARTONGEL111
35781-0300-3Lido Rx28.5 g in 1 TUBEGEL28.511
35781-0300-3Lido Rx1 in 1 CARTONGEL111
35781-0300-9Lido Rx85.5 g in 1 TUBEGEL85.511
35781-0300-9Lido Rx1 in 1 CARTONGEL111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
35781-0300-1ML - Milliliter35781-03000aa95b02-c5cf-43bb-9155-09f95efa63fa12014-02-04
35781-0300-3ML - Milliliter35781-03001a9ca3f9-25dc-4e20-a5fc-fdf83f20c12912013-04-01
35781-0300-9ML - Milliliter35781-030028555464-3e02-4b26-bc67-1ca18300b42712015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINEACTIVE INGREDIENT98PI200987LIDOCAINE HYDROCHLORIDE (LIDOCAINE) GEL [GENSCO LABORATORIES, LLC]3
LIDOCAINEACTIVE MOIETY98PI200987LIDOCAINE HYDROCHLORIDE (LIDOCAINE) GEL [GENSCO LABORATORIES, LLC]3
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT809Y72KV36LIDOCAINE HYDROCHLORIDE (LIDOCAINE) GEL [GENSCO LABORATORIES, LLC]3
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302LIDOCAINE HYDROCHLORIDE (LIDOCAINE) GEL [GENSCO LABORATORIES, LLC]3
PETROLATUMINACTIVE INGREDIENT4T6H12BN9ULIDOCAINE HYDROCHLORIDE (LIDOCAINE) GEL [GENSCO LABORATORIES, LLC]3
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHLIDOCAINE HYDROCHLORIDE (LIDOCAINE) GEL [GENSCO LABORATORIES, LLC]3
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKLIDOCAINE HYDROCHLORIDE (LIDOCAINE) GEL [GENSCO LABORATORIES, LLC]3
WATERINACTIVE INGREDIENT059QF0KO0RLIDOCAINE HYDROCHLORIDE (LIDOCAINE) GEL [GENSCO LABORATORIES, LLC]3
LIDOCAINEACTIVE INGREDIENT98PI200987LIDOCAINE HYDROCHLORIDE (LIDOCAINE) GEL [AIDAREX PHARMACEUTICALS LLC]1
LIDOCAINEACTIVE INGREDIENT98PI200987LIDOCAINE HYDROCHLORIDE (LIDOCAINE) GEL [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
LIDOCAINEACTIVE MOIETY98PI200987LIDOCAINE HYDROCHLORIDE (LIDOCAINE) GEL [AIDAREX PHARMACEUTICALS LLC]1
LIDOCAINEACTIVE MOIETY98PI200987LIDOCAINE HYDROCHLORIDE (LIDOCAINE) GEL [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT809Y72KV36LIDOCAINE HYDROCHLORIDE (LIDOCAINE) GEL [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT809Y72KV36LIDOCAINE HYDROCHLORIDE (LIDOCAINE) GEL [AIDAREX PHARMACEUTICALS LLC]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302LIDOCAINE HYDROCHLORIDE (LIDOCAINE) GEL [AIDAREX PHARMACEUTICALS LLC]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302LIDOCAINE HYDROCHLORIDE (LIDOCAINE) GEL [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9ULIDOCAINE HYDROCHLORIDE (LIDOCAINE) GEL [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9ULIDOCAINE HYDROCHLORIDE (LIDOCAINE) GEL [AIDAREX PHARMACEUTICALS LLC]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHLIDOCAINE HYDROCHLORIDE (LIDOCAINE) GEL [AIDAREX PHARMACEUTICALS LLC]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHLIDOCAINE HYDROCHLORIDE (LIDOCAINE) GEL [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKLIDOCAINE HYDROCHLORIDE (LIDOCAINE) GEL [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKLIDOCAINE HYDROCHLORIDE (LIDOCAINE) GEL [AIDAREX PHARMACEUTICALS LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RLIDOCAINE HYDROCHLORIDE (LIDOCAINE) GEL [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RLIDOCAINE HYDROCHLORIDE (LIDOCAINE) GEL [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35781-0300LIDO RX (LIDOCAINE) GEL [GENSCO LABORATORIES, LLC]11Legacy NDC, 6 package rows20221006_909baba8-9656-4769-97cf-b642982c3c9f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1372891lidocaine HCl 3 % Topical GelPSN909baba8-9656-4769-97cf-b642982c3c9f11
1372891lidocaine hydrochloride 0.03 MG/MG Topical GelSCD909baba8-9656-4769-97cf-b642982c3c9f11
1372891lidocaine hydrochloride 3 % Topical GelSY909baba8-9656-4769-97cf-b642982c3c9f11
1372891lidocaine HCl 3 % Topical GelPSN95ae61d8-d9a2-4e50-9065-c0cb97b957431
1372891lidocaine hydrochloride 0.03 MG/MG Topical GelSCD95ae61d8-d9a2-4e50-9065-c0cb97b957431
1372891lidocaine hydrochloride 3 % Topical GelSY95ae61d8-d9a2-4e50-9065-c0cb97b957431

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
35781-0300-1357810300011 TUBE in 1 CARTON (35781-0300-1) > 9.5 g in 1 TUBE1 tube2015-09-280000-00-00NoNoCurrent