FDA.reportPublic FDA data

ELECTRUM NUMB ANESTHETIC

Product NDC
76348-600
11-digit product format
763480600
Labeler code
76348
Product ID
76348-600_d57c0e4a-ee74-e438-e053-2a95a90aeda5
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE HCl
Dosage form
SPRAY
Route
TOPICAL
Labeler
RENU LABORATORIES, INC.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-11-23
Marketing end
0000-00-00
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
4 g/112g
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct76348-600IInactivated by FDA2026-10-05
excluded packagepackage76348-60076348-600-04IInactivated 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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage76348-600-04d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage76348-600-04f5e01cc5f278…a2eaf40c39c3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage76348-600-041332a3947898…d4bfe170f9cd…

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
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76348-600-042025-07-29C16284748780-11030e365-4e38-111a-e063-dadaa90a10e2ELECTRUM NUMB SPRAY ANESTHETIC
76348-600-042024-03-21C16284748780-11030e365-4e38-111a-e063-dadaa90a10e2ELECTRUM NUMB SPRAY ANESTHETIC
76348-600-042024-01-30C16284748780-11030e365-4e38-111a-e063-dadaa90a10e2ELECTRUM NUMB SPRAY ANESTHETIC

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76348-600-04ELECTRUM NUMB ANESTHETIC112 g in 1 BOTTLE, SPRAYSPRAY1123

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76348-600ELECTRUM NUMB ANESTHETIC (LIDOCAINE HCL) SPRAY [RENU LABORATORIES, INC.]3Legacy NDC, 1 package rows20240322_b4ca450f-0833-c299-e053-2995a90afd56.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1045432lidocaine HCl 4 % Topical SprayPSNb4ca450f-0833-c299-e053-2995a90afd563
1045432lidocaine hydrochloride 40 MG/ML Topical SpraySCDb4ca450f-0833-c299-e053-2995a90afd563
1045432lidocaine HCl 4 % Topical SpraySYb4ca450f-0833-c299-e053-2995a90afd563
1045432lidocaine HCl 4 % Topical Spray GelSYb4ca450f-0833-c299-e053-2995a90afd563

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76348-600-0476348060004112 g in 1 BOTTLE, SPRAY (76348-600-04) 112 g2020-11-230000-00-00NoNoCurrent