FDA.reportPublic FDA data

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

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 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