FDA.reportPublic FDA data

LIDOTHOL

Product NDC
53225-1025
Requested package NDC
53225-1025-1
11-digit product format
532251025
Labeler code
53225
Product ID
53225-1025_eeb78341-71f3-1dfc-e053-2a95a90afcb5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LIDOCAINE, MENTHOL
Dosage form
PATCH
Route
TOPICAL
Labeler
Terrain Pharmaceuticals
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2015-06-16
Marketing end
0000-00-00
Substance
LIDOCAINE; MENTHOL
Active strength
5 g/1; g/1
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 packagepackage53225-102553225-1025-1DDiscontinued by firm2026-10-05

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 · 11 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…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53225-1025-1EA - Each53225-102578560d8e-5146-45fe-b34e-de608d3c1f1412015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINEACTIVE INGREDIENT98PI200987LIDOTHOL (LIDOCAINE, MENTHOL) PATCH [TERRAIN PHARMACEUTICALS]5
MENTHOLACTIVE INGREDIENTL7T10EIP3ALIDOTHOL (LIDOCAINE, MENTHOL) PATCH [TERRAIN PHARMACEUTICALS]5
LIDOCAINEACTIVE MOIETY98PI200987LIDOTHOL (LIDOCAINE, MENTHOL) PATCH [TERRAIN PHARMACEUTICALS]5
MENTHOLACTIVE MOIETYL7T10EIP3ALIDOTHOL (LIDOCAINE, MENTHOL) PATCH [TERRAIN PHARMACEUTICALS]5
ACRYLIC ACIDINACTIVE INGREDIENTJ94PBK7X8SLIDOTHOL (LIDOCAINE, MENTHOL) PATCH [TERRAIN PHARMACEUTICALS]5
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN0LIDOTHOL (LIDOCAINE, MENTHOL) PATCH [TERRAIN PHARMACEUTICALS]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48LIDOTHOL (LIDOCAINE, MENTHOL) PATCH [TERRAIN PHARMACEUTICALS]5
ETHYLHEXYL ACETATEINACTIVE INGREDIENT2C7K8OA8SBLIDOTHOL (LIDOCAINE, MENTHOL) PATCH [TERRAIN PHARMACEUTICALS]5
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLIDOTHOL (LIDOCAINE, MENTHOL) PATCH [TERRAIN PHARMACEUTICALS]5
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSLIDOTHOL (LIDOCAINE, MENTHOL) PATCH [TERRAIN PHARMACEUTICALS]5
METHYL ACRYLATEINACTIVE INGREDIENTWC487PR91HLIDOTHOL (LIDOCAINE, MENTHOL) PATCH [TERRAIN PHARMACEUTICALS]5
NONOXYNOL-30INACTIVE INGREDIENTJJX07DG188LIDOTHOL (LIDOCAINE, MENTHOL) PATCH [TERRAIN PHARMACEUTICALS]5
POLYACRYLIC ACID (8000 MW)INACTIVE INGREDIENT73861X4K5FLIDOTHOL (LIDOCAINE, MENTHOL) PATCH [TERRAIN PHARMACEUTICALS]5
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HLIDOTHOL (LIDOCAINE, MENTHOL) PATCH [TERRAIN PHARMACEUTICALS]5
SODIUM POLYACRYLATE (2500000 MW)INACTIVE INGREDIENT05I15JNI2JLIDOTHOL (LIDOCAINE, MENTHOL) PATCH [TERRAIN PHARMACEUTICALS]5
SORBITAN SESQUIOLEATEINACTIVE INGREDIENT0W8RRI5W5ALIDOTHOL (LIDOCAINE, MENTHOL) PATCH [TERRAIN PHARMACEUTICALS]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLIDOTHOL (LIDOCAINE, MENTHOL) PATCH [TERRAIN PHARMACEUTICALS]5
TALCINACTIVE INGREDIENT7SEV7J4R1ULIDOTHOL (LIDOCAINE, MENTHOL) PATCH [TERRAIN PHARMACEUTICALS]5
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HLIDOTHOL (LIDOCAINE, MENTHOL) PATCH [TERRAIN PHARMACEUTICALS]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLIDOTHOL (LIDOCAINE, MENTHOL) PATCH [TERRAIN PHARMACEUTICALS]5
WATERINACTIVE INGREDIENT059QF0KO0RLIDOTHOL (LIDOCAINE, MENTHOL) PATCH [TERRAIN PHARMACEUTICALS]5

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1653326lidocaine 4.5 % / menthol 5 % Medicated PatchPSNac3979c4-78b9-4122-bbcc-a3e6293fc9519
1653326lidocaine 0.045 MG/MG / menthol 0.05 MG/MG Medicated PatchSCDac3979c4-78b9-4122-bbcc-a3e6293fc9519
1653326lidocaine 4.5 % / menthol 5 % Medicated PatchSYac3979c4-78b9-4122-bbcc-a3e6293fc9519

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53225-1025-15322510250115 PATCH in 1 BOX (53225-1025-1) > 1 PATCH in 1 PATCH15 patch2015-06-160000-00-00NoNoCurrent