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 22 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eagle Brand Muscle RubMENTHOL, METHYL SALICYLATEBorden Company (Private) Limited06cb845c-cc53-1f1d-e063-6394a90a8c012026-04-27WarningsExact identifier
application number: M017
Eagle Brand Medicated Oil AromaticCAMPHOR, MENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA0ef7c3aa-94a3-9fe9-e063-6394a90ab13d2026-04-27WarningsExact identifier
application number: M017
Eagle Brand Medicated OilMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA5071f145-49f7-0855-e063-6394a90a8f262026-04-27WarningsExact identifier
application number: M017
Eagle Brand Medicated Oil RefreshCAMPHOR, MENTHOLPT. EAGLE INDO PHARMA09260c31-56a3-07aa-e063-6394a90a95fd2026-04-27WarningsExact identifier
application number: M017
Eagle Brand Muscle RubMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA5072ad57-9fa7-ddba-e063-6394a90a319b2026-04-27WarningsExact identifier
application number: M017
Eagle Brand Medicated Roll On RefreshCAMPHOR, MENTHOLPT. EAGLE INDO PHARMA09235f26-2262-6ca2-e063-6394a90ad8f12026-04-27WarningsExact identifier
application number: M017
Eagle Brand Medicated Roll On AromaticCAMPHOR, MENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA0f333f93-bec6-72d5-e063-6394a90a4e3f2026-04-27WarningsExact identifier
application number: M017
HIP PAIN RELIEF ROLL-ONLIDOCAINE AND MENTHOLGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.502f1f9e-8552-ca7b-e063-6394a90a7c532026-04-24WarningsExact identifier
application number: M017
SOMBRA WARM THERAPYMENTHOL CAMPHORSOMBRA COSMETICS INC.de78dba9-53b3-4dbd-9dd2-6a692378da342026-04-24WarningsExact identifier
application number: M017
Rite Aid Itch ReliefDIPHENHYDRAMINE HCL 2%, ZINC ACETATE 0.1%Rite Aide285df43-317c-d862-e053-2a95a90acdce2026-04-23WarningsExact identifier
application number: M017
FixMySkin Healing Balm UnflavoredHYDROCORTISONELovely Skin, Inc.9ff8db07-ad6d-4865-a534-94bd8312957e2026-04-23WarningsExact identifier
application number: M017
DCH Labs CortisoneHYDROCORTISONE 1%Derma Care Research Labs5025f53a-02e0-0f6a-e063-6394a90adbbf2026-04-23WarningsExact identifier
application number: M017
Hydrocortisone 1%HYDROCORTISONEPreferred Pharmaceuticals Inc.e0f46445-64c5-4f5d-90b0-3fa07ed7d1b42026-04-22WarningsExact identifier
application number: M017
Dr. Carrasco Pain ReliefMENTHOLCarrasco Enterprises, Inc.befa8526-f468-428e-a829-422c2ea486122026-04-21WarningsExact identifier
application number: M017
HealthWise Feminine Anti-itch CreamBENZOCAINE, RESORCINOLVeridian Healthcare4ff88b9e-5869-a1cb-e063-6294a90a87b72026-04-21WarningsExact identifier
application number: M017
SOMBRA COOL THERAPYMENTHOLSOMBRA COSMETICS INC.87e9b16b-1cab-48f7-b9e4-1c3eaeeb3ca32026-04-21WarningsExact identifier
application number: M017
Careland Lidocaine Pain RelievingLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.c4c86a8f-1d57-49d2-a65f-acb0dccf2f872026-04-21WarningsExact identifier
application number: M017
KOXUO Arnica Bruise CreamARNICA BRUISE CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5003bf83-fa01-b01a-e063-6294a90ad37f2026-04-21WarningsExact identifier
application number: M017
KT Pain Relief Cream Magnesium with Arnica and 4% LidocaineKT PAIN RELIEF CREAM MAGNESIUM WITH ARNICA AND 4% LIDOCAINE ROLLONClarion Brands LLC4f82993c-ebc4-5787-e063-6294a90a12d62026-04-20WarningsExact identifier
application number: M017
KT Pain Relief Cream Magnesium with Cooling 5% MentholKT PAIN RELIEF CREAM MAGNESIUM WITH COOLING 5% MENTHOLClarion Brands LLC4fe64056-f3c6-bc76-e063-6294a90a7e622026-04-20WarningsExact 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