FDA.reportPublic FDA data

Solarcaine

Product NDC
11523-0404
Requested package NDC
11523-0404-1
11-digit product format
115230404
Labeler code
11523
Product ID
11523-0404_eb02ce89-78d1-3eed-e053-2995a90ac52a
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine
Dosage form
SPRAY
Route
TOPICAL
Labeler
Bayer HealthCare LLC.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-04-06
Marketing end
0000-00-00
Substance
LIDOCAINE
Active strength
5 mg/g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage11523-040411523-0404-1DDiscontinued by firm2026-09-14

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, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LidocaineACTIVE INGREDIENT98PI200987SOLARCAINE (LIDOCAINE) SPRAY [MSD CONSUMER CARE, INC.]2
LidocaineACTIVE MOIETY98PI200987SOLARCAINE (LIDOCAINE) SPRAY [MSD CONSUMER CARE, INC.]2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0SOLARCAINE (LIDOCAINE) SPRAY [MSD CONSUMER CARE, INC.]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XSOLARCAINE (LIDOCAINE) SPRAY [MSD CONSUMER CARE, INC.]2
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4SOLARCAINE (LIDOCAINE) SPRAY [MSD CONSUMER CARE, INC.]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSOLARCAINE (LIDOCAINE) SPRAY [MSD CONSUMER CARE, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSOLARCAINE (LIDOCAINE) SPRAY [MSD CONSUMER CARE, INC.]2
ISOBUTANEINACTIVE INGREDIENTBXR49TP611SOLARCAINE (LIDOCAINE) SPRAY [MSD CONSUMER CARE, INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSOLARCAINE (LIDOCAINE) SPRAY [MSD CONSUMER CARE, INC.]2
PROPANEINACTIVE INGREDIENTT75W9911L6SOLARCAINE (LIDOCAINE) SPRAY [MSD CONSUMER CARE, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SOLARCAINE (LIDOCAINE) SPRAY [MSD CONSUMER CARE, INC.]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHSOLARCAINE (LIDOCAINE) SPRAY [MSD CONSUMER CARE, INC.]2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKSOLARCAINE (LIDOCAINE) SPRAY [MSD CONSUMER CARE, INC.]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11523-0404-111523040401127 g in 1 CAN (11523-0404-1) 127 g2016-03-010000-00-00NoNoCurrent