Home NDC 53225-1025 LIDOTHOL
Product NDC 53225-1025
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 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 · 22 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 53225-1025-1 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 53225-1025-1 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 53225-1025-1 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 53225-1025-1 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 53225-1025-1 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 53225-1025-1 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 53225-1025-1 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 53225-1025-1 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 53225-1025-1 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 53225-1025-1 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 53225-1025-1 367a005e9d99…383a685ebd0f…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LIDOCAINE ACTIVE INGREDIENT 98PI200987 LIDOTHOL (LIDOCAINE, MENTHOL) PATCH [TERRAIN PHARMACEUTICALS] 5 MENTHOL ACTIVE INGREDIENT L7T10EIP3A LIDOTHOL (LIDOCAINE, MENTHOL) PATCH [TERRAIN PHARMACEUTICALS] 5 LIDOCAINE ACTIVE MOIETY 98PI200987 LIDOTHOL (LIDOCAINE, MENTHOL) PATCH [TERRAIN PHARMACEUTICALS] 5 MENTHOL ACTIVE MOIETY L7T10EIP3A LIDOTHOL (LIDOCAINE, MENTHOL) PATCH [TERRAIN PHARMACEUTICALS] 5 ACRYLIC ACID INACTIVE INGREDIENT J94PBK7X8S LIDOTHOL (LIDOCAINE, MENTHOL) PATCH [TERRAIN PHARMACEUTICALS] 5 ALUMINUM HYDROXIDE INACTIVE INGREDIENT 5QB0T2IUN0 LIDOTHOL (LIDOCAINE, MENTHOL) PATCH [TERRAIN PHARMACEUTICALS] 5 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 LIDOTHOL (LIDOCAINE, MENTHOL) PATCH [TERRAIN PHARMACEUTICALS] 5 ETHYLHEXYL ACETATE INACTIVE INGREDIENT 2C7K8OA8SB LIDOTHOL (LIDOCAINE, MENTHOL) PATCH [TERRAIN PHARMACEUTICALS] 5 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX LIDOTHOL (LIDOCAINE, MENTHOL) PATCH [TERRAIN PHARMACEUTICALS] 5 ISOPROPYL MYRISTATE INACTIVE INGREDIENT 0RE8K4LNJS LIDOTHOL (LIDOCAINE, MENTHOL) PATCH [TERRAIN PHARMACEUTICALS] 5 METHYL ACRYLATE INACTIVE INGREDIENT WC487PR91H LIDOTHOL (LIDOCAINE, MENTHOL) PATCH [TERRAIN PHARMACEUTICALS] 5 NONOXYNOL-30 INACTIVE INGREDIENT JJX07DG188 LIDOTHOL (LIDOCAINE, MENTHOL) PATCH [TERRAIN PHARMACEUTICALS] 5 POLYACRYLIC ACID (8000 MW) INACTIVE INGREDIENT 73861X4K5F LIDOTHOL (LIDOCAINE, MENTHOL) PATCH [TERRAIN PHARMACEUTICALS] 5 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H LIDOTHOL (LIDOCAINE, MENTHOL) PATCH [TERRAIN PHARMACEUTICALS] 5 SODIUM POLYACRYLATE (2500000 MW) INACTIVE INGREDIENT 05I15JNI2J LIDOTHOL (LIDOCAINE, MENTHOL) PATCH [TERRAIN PHARMACEUTICALS] 5 SORBITAN SESQUIOLEATE INACTIVE INGREDIENT 0W8RRI5W5A LIDOTHOL (LIDOCAINE, MENTHOL) PATCH [TERRAIN PHARMACEUTICALS] 5 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LIDOTHOL (LIDOCAINE, MENTHOL) PATCH [TERRAIN PHARMACEUTICALS] 5 TALC INACTIVE INGREDIENT 7SEV7J4R1U LIDOTHOL (LIDOCAINE, MENTHOL) PATCH [TERRAIN PHARMACEUTICALS] 5 TARTARIC ACID INACTIVE INGREDIENT W4888I119H LIDOTHOL (LIDOCAINE, MENTHOL) PATCH [TERRAIN PHARMACEUTICALS] 5 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LIDOTHOL (LIDOCAINE, MENTHOL) PATCH [TERRAIN PHARMACEUTICALS] 5 WATER INACTIVE INGREDIENT 059QF0KO0R LIDOTHOL (LIDOCAINE, MENTHOL) PATCH [TERRAIN PHARMACEUTICALS] 5
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53225-1025-1 53225102501 15 PATCH in 1 BOX (53225-1025-1) > 1 PATCH in 1 PATCH 15 patch 2015-06-16 0000-00-00 No No Current