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 103 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Arthritis HotMENTHOL AND METHYL SALICYLATEChattem, Inc.cc57b9b6-8ba5-4ff3-a5df-97d8f5b1bebd2025-01-13WarningsExact identifier
application number: M017
Re-Lieved Lidocaine PatchLIDOCAINE PATCH 4%Transfer Technology00b40dda-53ad-0458-e063-6394a90aa8352025-01-11WarningsExact identifier
application number: M017
Re-Lieved Lidocaine PatchLIDOCAINE PATCH 4%Transfer Technology00b47eb7-6b43-d9e2-e063-6294a90a9a382025-01-11WarningsExact identifier
application number: M017
Re-Lieved 4% Lidocaine Fabric TapeLIDOCAINE 4% FABRIC TAPETransfer Technologye9a894b0-54f2-707e-e053-2a95a90a0f0d2025-01-11WarningsExact identifier
application number: M017
Re-Lieved 3 in 1 PatchMENTHOL, CAMPHOR, METHYL SALICYLATE PATCHTransfer Technologye9ab9a03-b9e3-7317-e053-2995a90a99502025-01-11WarningsExact identifier
application number: M017
ASTRAPHARM CHILLI BRANDCAPSAICINDersan Pharmaceutical Co., Ltdb4c2d4fd-7d5d-4156-ac27-e72ebc9671ec2025-01-10WarningsExact identifier
application number: M017
LABOFLEX Lidocaine Pain Relieving PatchLIDOCAINE 4%Laboflex, Inc.31995f31-c272-afdb-e063-6294a90af3f92025-01-10WarningsExact identifier
application number: M017
Anti-Itch CreamDIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1%Chain Drug Marketing Association Inc.2b48cb2f-e6bf-f9de-e063-6394a90a42d42025-01-09WarningsExact identifier
application number: M017
PAIN-XMENTHOLOL PHARMA TECH,LLCb22bb19a-14e5-3d32-e053-2a95a90ae5202025-01-09WarningsExact identifier
application number: M017
MUSCLE RUBMENTHOLOL PHARMA TECH,LLCb22c7999-52d5-25c3-e053-2a95a90a01f52025-01-09WarningsExact identifier
application number: M017
Biofreeze Professional Colorless Roll-OnMENTHOL, UNSPECIFIED FORMA-S Medication Solutionsce392c4f-cc43-484d-9c49-18fa25e4e5e92025-01-09WarningsExact identifier
application number: M017
NEW TEROCINMETHYL SALICYLATE, CAPSAICIN, AND MENTHOLA-S Medication Solutions43e5eb27-5541-4b7b-80de-55a79a4dce552025-01-09WarningsExact identifier
application number: M017
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMA-S Medication Solutionscbeac814-59d8-4c13-8e73-bca66f797f8d2025-01-09WarningsExact identifier
application number: M017
Bactine MaxLIDOCAINEWellSpring Pharmaceutical Corporationacd7ae37-7c42-4ec7-a2ef-42e7f628388d2025-01-08WarningsExact identifier
application number: M017
THERABLAST MAXIMUM RELIEFLIDOCAINE, MENTHOLReleaf Technologies LLC09809985-3a88-9bb7-e063-6394a90a2f5f2025-01-08WarningsExact identifier
application number: M017
ANTI ITCHHYDROCORTISONESafeway0bfa1653-76b7-48ed-a896-a0b5fc3bd7942025-01-08WarningsExact identifier
application number: M017
Sting Relief SwabBENZOCAINEEpic Medical Supply Corp259fbfe4-d67c-ea1e-e063-6294a90a0fb02025-01-07WarningsExact identifier
application number: M017
Sinsin MulpasCAMPHOR, MENTHOL, METHYL SALICYLATESinsin Pharmaceutical Co., Ltd.22ea8a51-fdee-4650-abf8-f996268c93032025-01-07WarningsExact identifier
application number: M017
SINSINPAP COOLLEVOMENTHOL, THYMOL, CAMPHOR, MENTHA, EUCALYPTUSSinsin Pharmaceutical Co., Ltd.9d47855f-ccb5-4557-a31a-a2b336fa98062025-01-07WarningsExact identifier
application number: M017
Burn JelLIDOCAINE HYDROCHLORIDEWater-Jel Technologiesff621b46-2342-41db-994d-851a09796d082025-01-06WarningsExact 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