FDA.reportPublic FDA data

1ST MEDXPATCH

Product NDC
72137-113
11-digit product format
721370113
Labeler code
72137
Product ID
72137-113_47e43c9c-990e-c2e4-e063-6394a90a3265
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LIDOCAINE, CAPSAICIN, MENTHOL, METHYL SALICYLATE
Dosage form
PATCH
Route
TOPICAL
Labeler
1ST MEDX LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2018-03-15
Substance
CAPSAICIN; LIDOCAINE; MENTHOL; METHYL SALICYLATE
Active strength
.0375; 4; 5; 20 g/1; g/1; g/1; g/1
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
1ST MEDXPATCH
Brand name suffix
WITH LIDOCAINE 4%-RX
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPSAICIN.0375 g/1
LIDOCAINE4 g/1
MENTHOL5 g/1
METHYL SALICYLATE20 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiS07O44R1ZM, 98PI200987, L7T10EIP3A, LAV5U5022Y
Rxcui2001686

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72137-113-152022-02-01C16284748780-1d6a99b39-84cb-a426-e053-dadaa90af4c21ST MEDX (as PLD) - PATCH WITH LIDOCAINE 4%-RX (72137-113) - DELIST
72137-113-152022-02-01C16284748780-1d6a99b39-84cb-a426-e053-dadaa90af4c21ST MEDX (as PLD) - PATCH WITH LIDOCAINE 4%-RX (72137-113) - DELIST
72137-113-152022-01-28C16284748780-1d6a99b39-84cb-a426-e053-dadaa90af4c21ST MEDX (as PLD) - PATCH WITH LIDOCAINE 4%-RX (72137-113) - DELIST
72137-113-152022-01-28C16284748780-1d6a99b39-84cb-a426-e053-dadaa90af4c21ST MEDX (as PLD) - PATCH WITH LIDOCAINE 4%-RX (72137-113) - DELIST

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72137-113-011ST MEDXPATCHWITH LIDOCAINE 4%-RX1 in 1 PATCHPATCH111
72137-113-151ST MEDXPATCHWITH LIDOCAINE 4%-RX10 in 1 POUCHPATCH1011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72137-113-01EA - Each72137-1133df4bb61-25c6-4ac6-9b41-5591e4af92a912022-06-06
72137-113-15EA - Each72137-1134a157ee1-ff39-4b0b-a228-1d67b113d3c912018-04-19

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2001686capsaicin 0.0375 % / lidocaine 4 % / menthol 5 % / methyl salicylate 20 % Medicated PatchPSNb55585cf-45da-4b78-b68e-f7dddf23bfe711
2001686capsaicin 0.000375 MG/MG / lidocaine 0.04 MG/MG / menthol 0.05 MG/MG / methyl salicylate 0.2 MG/MG Medicated PatchSCDb55585cf-45da-4b78-b68e-f7dddf23bfe711
2001686capsaicin 0.0375 % / lidocaine 4 % / menthol 5 % / methyl salicylate 20 % Medicated PatchSYb55585cf-45da-4b78-b68e-f7dddf23bfe711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72137-113-01721370113011 in 1 PATCHHistorical
72137-113-157213701131510 PATCH in 1 POUCH (72137-113-15) / 1 PATCH in 1 PATCH (72137-113-01) 10 patch2018-03-180000-00-00NoNoCurrent