FDA.reportPublic FDA data

Lidocaine

Product NDC
41520-162
11-digit product format
415200162
Labeler code
41520
Product ID
41520-162_422a7da3-a992-d61d-e063-6294a90a3789
Type
HUMAN OTC DRUG
Nonproprietary name
Burn Relief
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
Foodhold USA
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-12-19
Substance
LIDOCAINE
Active strength
.64 g/127g
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

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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage41520-162-45fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage41520-162-4586f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage41520-162-45bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage41520-162-458dfbde2a14a4…c9ff85d89658…

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
LIDOCAINE.64 g/127g

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
1442274Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b25dc0df-02d0-41ac-b36c-2c04baa77ef2Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-01-17Burn Relief Spray
2024-01-17Burn Relief Spray
2021-07-23Burn Relief Spray
2021-07-23Burn Relief Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-162-45Lidocaine127 g in 1 CANAEROSOL, SPRAY1279

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-162LIDOCAINE (BURN RELIEF) AEROSOL, SPRAY [FOODHOLD USA]8Current NDC, Legacy NDC, 1 package rows20241220_b25dc0df-02d0-41ac-b36c-2c04baa77ef2.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 117 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MYCO Clinic Pain ReliefMENTHOLAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions604a30c9-2306-47a1-bd31-94b63639dd902024-11-20WarningsExact identifier
application number: M017
MYCO Clinic Pain ReliefCAMPHOR, MENTHOLAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions0b489420-3b5c-43c5-aab4-0e3720acf9ce2024-11-20WarningsExact identifier
application number: M017
MYCO Clinic Pain ReliefCAMPHOR, MENTHOLAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutionsdd906129-a787-4352-856d-d7a915031a6e2024-11-20WarningsExact identifier
application number: M017
Walgreens Arthritis Pain Relief CreamHISTAMINE DIHYDROCHLORIDEWalgreens Company80d3031a-7fa9-4f5b-b85e-c7c6ef3148012024-11-20WarningsExact identifier
application number: M017
Anti-Itch Medicated Maximum StrengthBENZOCAINE AND RESORCINOLWalgreens Company7fd86dcb-edef-4d0d-b389-7ecea595fe672024-11-20WarningsExact identifier
application number: M017
Walgreens Pain ReliefBENZOCAINEWalgreens Company7cee7234-32cd-4bf3-8a6c-0882585eec7f2024-11-20WarningsExact identifier
application number: M017
Walgreens Advanced Scar GelADVANCED SCAR GELWalgreens Company2c040475-a124-485c-933e-66b452f5ab462024-11-20WarningsExact identifier
application number: M017
LidoPro Pain ReliefCAPSAICIN AND LIDOCAINEClinic Pharma274611ea-7fc2-ba3f-e063-6294a90aa50f2024-11-19WarningsExact identifier
application number: M017
First Aid Only Sting Relief PadBENZOCAINEAcme United Corporation5087cbbd-1bbe-62ed-e054-00144ff8d46c2024-11-19WarningsExact identifier
application number: M017
Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOLAcme United Corporation6bb9a782-2394-4c8c-e053-2991aa0a08d42024-11-19WarningsExact identifier
application number: M017
First Aid Only Sting ReliefBENZOCAINEAcme United Corporation697127d1-c02e-16d2-e053-2a91aa0a39fd2024-11-19WarningsExact identifier
application number: M017
First Aid Only Hydrocortisone 1% Anti-ItchHYDROCORTISONEAcme United Corporatione5597b11-b08e-99e1-e053-2a95a90a15a52024-11-19WarningsExact identifier
application number: M017
Equate Cold Therapy Pain Relieving Roll-on AnalgesicMENTHOL, UNSPECIFIED FORMWal-Mart Stores, Inc.4115f0ac-e12a-4e59-94f5-a47dcc7f87662024-11-18WarningsExact identifier
application number: M017
Equate Cold Therapy Pain Relieving AnalgesicMENTHOL, UNSPECIFIED FORMWal-Mart Stores, Inc.ac6c2112-8692-4628-97d8-3a5a9f5097662024-11-18WarningsExact identifier
application number: M017
Equate Odor-Free Therapy Arthritis AnalgesicTROLAMINE SALICYLATEWal-Mart Stores, Inc.1d73e7b6-c7f9-4680-b3e3-a954b91e18632024-11-18WarningsExact identifier
application number: M017
First Aid Only BurnLIDOCAINE HYDROCHLORIDEAcme United Corporation9af39fcd-0a57-26d0-e053-2a95a90a99a02024-11-17WarningsExact identifier
application number: M017
First Aid Only First Aid/BurnLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEAcme United Corporationcaa67a05-bdbd-c380-e053-2995a90a0bf12024-11-17WarningsExact identifier
application number: M017
Meijer Pain Lidocaine Plus Relieving AnalgesicBENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDEMeijer Distribution, Incb7385140-3f63-4cbc-b557-de1d29d1ea362024-11-15WarningsExact identifier
application number: M017
Signature Care HydrocortisoneHYDROCORTISONESafewayc6b9c4e1-bab8-490d-8c00-c43377ad08572024-11-15WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEWalgreen Company1a9b8b4c-3e15-49e6-af91-76ed0dc0829e2024-11-15WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1442274lidocaine 0.5 % Topical SprayPSNb25dc0df-02d0-41ac-b36c-2c04baa77ef29
1442274lidocaine 5 MG/ML Topical SpraySCDb25dc0df-02d0-41ac-b36c-2c04baa77ef29
1442274lidocaine 0.5 % Topical SpraySYb25dc0df-02d0-41ac-b36c-2c04baa77ef29

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-162-4541520016245127 g in 1 CAN (41520-162-45) 127 g2017-12-190000-00-00NoNoCurrent