FDA.reportPublic FDA data

Lidocaine

Product NDC
58980-824
11-digit product format
589800824
Labeler code
58980
Product ID
58980-824_6d26e7b3-bcd8-46de-9ae1-6010b4014fc1
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine
Dosage form
CREAM
Route
TOPICAL
Labeler
Stratus Pharmaceuticals Inc
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-02-15
Substance
LIDOCAINE
Active strength
40 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
Lidocaine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE40 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
98PI200987Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1421893Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e1a8d4a7-01f7-4bab-8d09-875c461b3b61Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58980-824-05Lidocaine1 in 1 BOXCREAM12
58980-824-05Lidocaine14.17 g in 1 TUBECREAM14.172
58980-824-15Lidocaine5 in 1 BOX, UNIT-DOSECREAM52
58980-824-15Lidocaine5 g in 1 TUBECREAM52
58980-824-30Lidocaine28.35 g in 1 TUBECREAM28.352
58980-824-30Lidocaine1 in 1 BOXCREAM12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58980-824-05GM - Gram58980-82413fde5f1-ab56-4bf0-b57c-7280acc43dab12024-10-04
58980-824-15GM - Gram58980-8242d5aa8ba-de05-43b4-8a77-5776bb3c148f12024-10-04
58980-824-30GM - Gram58980-824a8dfea61-8933-4b05-83f6-d835c8e9c95812024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58980-824LIDOCAINE CREAM [STRATUS PHARMACEUTICALS INC]2Current NDC, 6 package rows20240922_e1a8d4a7-01f7-4bab-8d09-875c461b3b61.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 77 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Xpect Extra Strength Itch ReliefDIPHENHYDRAMINE HYDROCHLORIDECintas Corporationa373b2c3-5c58-4b64-9358-bdf42dfce08c2025-09-24WarningsExact identifier
application number: M017
Xpect Burn CareBURN CARECintas Corp3665eb99-9602-4949-8af4-3ce7ed24303c2025-09-23WarningsExact identifier
application number: M017
Sheffield Arthritis and Muscle Pain ReliefCAPSICUM OLEORESINSheffield Pharmaceuticals LLC80a1bc65-2986-491f-a062-307d28b08ccb2025-09-22WarningsExact identifier
application number: M017
TheraCare Roll-on Menthol 16% Pain Relief LiquidMENTHOLVeridian Healthcared932050d-2a9a-4a5e-b45d-0a7a864582e02025-09-22WarningsExact identifier
application number: M017
TheraCare Roll-on Menthol 4% Pain ReliefMENTHOLVeridian Healthcarefa121e5f-94b5-4c1d-9c4e-85bb8ede39452025-09-22WarningsExact identifier
application number: M017
Asper FlexLIDOCAINEAkron Pharma Inc.06ddae64-cda7-4eb9-872f-5182c83cb00c2025-09-19WarningsExact identifier
application number: M017
Good Neighbor Pain Relief Patch With Lidocaine 4%LIDOCAINEAmerisource Bergen5f5cc887-d479-4c9a-affc-49d0c331f7422025-09-18WarningsExact identifier
application number: M017
TheraCare Roll-on Lidocaine Pain Relief LiquidLIDOCAINE HCIVeridian Healthcaree942d447-754d-4683-9c99-57c7e83d7ea82025-09-18WarningsExact identifier
application number: M017
TheraCare Roll-on Lidocaine Pain Relief Liquid - LavenderLIDOCAINE HCIVeridian Healthcare6bebce76-30f6-4070-b0fe-58246d0713282025-09-18WarningsExact identifier
application number: M017
HealthWise Roll-On Lidocaine Pain Relief LiquidLIDOCAINE HCIVeridian Healthcare1133f6d4-f4c0-4ce9-e063-6394a90a5f4e2025-09-18WarningsExact identifier
application number: M017
InkKulture NumbingLIDOCAINE HCLProdigy Media Inc85a64315-dfa5-4f23-9f61-1cce694ea6bd2025-09-17WarningsExact identifier
application number: M017
Ink Scribd NumbingLIDOCAINE HCLProdigy Media Inc54173858-aff0-43b2-bc7b-c4ecab9bc3e52025-09-17WarningsExact identifier
application number: M017
Inkorporated NumbingLIDOCAINE HCLProdigy Media Inc3017056c-f3c6-4300-8344-bf6e7d32e8702025-09-17WarningsExact identifier
application number: M017
TattooGirl NumbingLIDOCAINE HCLProdigy Media Inc6abe4540-f6c9-412a-83f3-682df77150572025-09-17WarningsExact identifier
application number: M017
Dr Tatty NumbingLIDOCAINE HCLProdigy Media Inc5bb558c1-bf8f-4956-8732-e19720f62f312025-09-17WarningsExact identifier
application number: M017
Burn Ease CoolingLIDOCAINEProStat First Aid LLCec201ca1-efa0-4797-aec3-115647c29abd2025-09-17WarningsExact identifier
application number: M017
MedFreeze Naturally Cool Pain ReliefMENTHOLMEDKO LLC240f2346-c585-4334-997c-45db6268d7c42025-09-15WarningsExact identifier
application number: M017
MEDISTIK DUAL HOT AND COLDMETHYL SALICYLATE, MENTHOLNatureteq Inc.ba5f4626-f077-4a28-8dcc-dacd50741ead2025-09-15WarningsExact identifier
application number: M017
MEDISTIK ICEMENTHOL, CAMPHORNatureteq Inc.c1077744-7b9a-4536-8faf-e21994a43ea52025-09-15WarningsExact identifier
application number: M017
Caring Mills Vaginal Anti-Itch CreamBENZOCAINE, RESORCINOLVeridian Healthcarecd379e74-2841-47e4-b95a-de1b341b397f2025-09-15WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1421893lidocaine 4 % Topical CreamPSNe1a8d4a7-01f7-4bab-8d09-875c461b3b612
1421893lidocaine 40 MG/ML Topical CreamSCDe1a8d4a7-01f7-4bab-8d09-875c461b3b612
1421893lidocaine 4 % Topical CreamSYe1a8d4a7-01f7-4bab-8d09-875c461b3b612

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58980-824-05589800824051 TUBE in 1 BOX (58980-824-05) / 14.17 g in 1 TUBE1 tube2024-09-20NoNoCurrent
58980-824-15589800824155 TUBE in 1 BOX, UNIT-DOSE (58980-824-15) / 5 g in 1 TUBE5 tube2024-09-20NoNoCurrent
58980-824-30589800824301 TUBE in 1 BOX (58980-824-30) / 28.35 g in 1 TUBE1 tube2024-02-15NoNoCurrent