FDA.reportPublic FDA data

AMPlify Relief MM

Product NDC
69837-019
11-digit product format
698370019
Labeler code
69837
Product ID
69837-019_6b074006-0212-4147-a5fa-2b1b85b1fb1f
Type
HUMAN OTC DRUG
Nonproprietary name
METHYL SALICYLATE, MENTHOL
Dosage form
CREAM
Route
TOPICAL
Labeler
International Brand Management, LLC
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2017-01-17
Marketing end
0000-00-00
Substance
METHYL SALICYLATE; MENTHOL
Active strength
3 g/10g; g/10g
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
111d457e-3138-4512-b0ba-d0cd760c4055Product name320250225
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
0426261e-1bb9-b78b-abd2-80da765a7e3eProduct name220240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7Product name520240320
0ac2f11f-f58d-baf2-71a0-680993b48a61Product name220231211
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
855d63c3-b090-4636-8fc7-6d39ad23c44fProduct name120230829
bb58f410-04be-65dd-9211-e89ead899698Product name620230323
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
0fcbc38a-8b29-3348-1cef-5222ea53484fProduct name420220516
c4e1eedc-aca2-4551-8382-89144ed9d049Product name320220126
8d368a34-1453-43ea-828d-0dbcd72b8794Product name820210622
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
d6bab9d2-edce-a213-4796-226ab15472c3Product name620200616
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
2487e6ef-d419-42fc-aaf8-7acc805d2370Product name220170718
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
e071c814-e5e7-e7ed-ec76-428765d9c66bProduct name220151120
93148e06-b8d7-4e6c-853e-62f807d17fbbProduct name120151014
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
dbb00be6-fb1c-4b0a-a770-31f7e05e247eProduct name120150316
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69837-019-012020-01-31C16284748780-19d75b9d1-0507-f424-e053-dadaa90a57ceef713a9f-4210-454c-8349-4f5e8b52000d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69837-019-01PainGo KFT1 in 1 CARTONCREAM1 g in 10g13
69837-019-02PainGo KFT118 g in 1 TUBECREAM118 g3 g in 10g13
69837-019-01LidoPR1 in 1 CARTONCREAM3 g in 10g5
69837-019-02LidoPR118 g in 1 TUBECREAM118 g1 g in 10g5
69837-019-01AMPlify Relief MM1 in 1 CARTONCREAM14
69837-019-02AMPlify Relief MM118 g in 1 TUBECREAM1184
69837-019-01DicloPR1 in 1 CARTONCREAM3 g in 10g3
69837-019-02DicloPR118 g in 1 TUBECREAM118 g3 g in 10g3
69837-019-01WPR Plus118 g in 1 TUBECREAM118 g3 g in 10g2
69837-019-01WPR Plus1 in 1 CARTONCREAM3 g in 10g2
69837-019-02WPR Plus118 g in 1 TUBECREAM118 g3 g in 10g2
69837-019-01WPR Plus118 g in 1 TUBECREAM118 g3 g in 10g1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69837-019-01GM - Gram69837-0191e8ada3b-d342-48b2-a84e-c5dca3bfe5d512017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69837-019PAINGO KFT (PRILOCAINE, LIDOCAINE, METHYL SALICYLATE, MENTHOL) KIT [INTERNATIONAL BRAND MANAGEMENT, LLC]13Legacy NDC20170308_cd9ca2e8-14fb-4d1e-bb31-7f354666e563.zip
69837-019LIDOPR (DICLOFENAC GEL, METHYL SALICYLATE, MENTHOL CREAM) KIT [19 AND PACIFIC, LLC]5Legacy NDC20171029_ec864730-a727-4a3d-a752-b03f4bd86988.zip
69837-019AMPLIFY RELIEF MM (METHYL SALICYLATE, MENTHOL) CREAM [INTERNATIONAL BRAND MANAGEMENT, LLC]4Legacy NDC, 2 package rows20170314_ef713a9f-4210-454c-8349-4f5e8b52000d.zip
69837-019DICLOPR (DICLOFENAC GEL, METHYL SALICYLATE, MENTHOL CREAM) KIT [19 AND PACIFIC, LLC]3Legacy NDC20171113_fa136af1-d3ea-4038-95af-e937555f8f5d.zip
69837-019WPR PLUS () KIT [INTERNATIONAL BRAND MANAGEMENT, LLC]2Legacy NDC20180801_9d830535-2202-482d-9d1a-bccd7bbba855.zip
69837-019WPR PLUS (METHYL SALICYLATE, MENTHOL) KIT [INTERNATIONAL BRAND MANAGEMENT, LLC]2Legacy NDC20180705_b2619163-01c4-4104-a40c-ee36e814e0c8.zip
69837-019WPR PLUS () KIT [INTERNATIONAL BRAND MANAGEMENT, LLC]1Legacy NDC20180717_793d6fad-31a7-4b28-8395-73825bc18508.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamPSNcd9ca2e8-14fb-4d1e-bb31-7f354666e56313
311500menthol 10 % / methyl salicylate 30 % Topical CreamPSNcd9ca2e8-14fb-4d1e-bb31-7f354666e56313
197877lidocaine 25 MG/ML / prilocaine 25 MG/ML Topical CreamSCDcd9ca2e8-14fb-4d1e-bb31-7f354666e56313
311500menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical CreamSCDcd9ca2e8-14fb-4d1e-bb31-7f354666e56313
197877lidocaine 2.5 % / prilocaine 2.5 % Topical CreamSYcd9ca2e8-14fb-4d1e-bb31-7f354666e56313
311500menthol 10 % / methyl salicylate 30 % Topical CreamSYcd9ca2e8-14fb-4d1e-bb31-7f354666e56313
855633diclofenac sodium 1 % Topical GelPSNec864730-a727-4a3d-a752-b03f4bd869885
311500menthol 10 % / methyl salicylate 30 % Topical CreamPSNec864730-a727-4a3d-a752-b03f4bd869885
855633diclofenac sodium 0.01 MG/MG Topical GelSCDec864730-a727-4a3d-a752-b03f4bd869885
311500menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical CreamSCDec864730-a727-4a3d-a752-b03f4bd869885
855633diclofenac sodium 1 % Topical GelSYec864730-a727-4a3d-a752-b03f4bd869885
311500menthol 10 % / methyl salicylate 30 % Topical CreamSYec864730-a727-4a3d-a752-b03f4bd869885
311500menthol 10 % / methyl salicylate 30 % Topical CreamPSNef713a9f-4210-454c-8349-4f5e8b52000d4
311500menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical CreamSCDef713a9f-4210-454c-8349-4f5e8b52000d4
311500menthol 10 % / methyl salicylate 30 % Topical CreamSYef713a9f-4210-454c-8349-4f5e8b52000d4
855633diclofenac sodium 1 % Topical GelPSNfa136af1-d3ea-4038-95af-e937555f8f5d3
311500menthol 10 % / methyl salicylate 30 % Topical CreamPSNfa136af1-d3ea-4038-95af-e937555f8f5d3
855633diclofenac sodium 0.01 MG/MG Topical GelSCDfa136af1-d3ea-4038-95af-e937555f8f5d3
311500menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical CreamSCDfa136af1-d3ea-4038-95af-e937555f8f5d3
855633diclofenac sodium 1 % Topical GelSYfa136af1-d3ea-4038-95af-e937555f8f5d3
311500menthol 10 % / methyl salicylate 30 % Topical CreamSYfa136af1-d3ea-4038-95af-e937555f8f5d3
311500menthol 10 % / methyl salicylate 30 % Topical CreamPSNb2619163-01c4-4104-a40c-ee36e814e0c82
311500menthol 10 % / methyl salicylate 30 % Topical CreamPSN9d830535-2202-482d-9d1a-bccd7bbba8552
311500menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical CreamSCDb2619163-01c4-4104-a40c-ee36e814e0c82
311500menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical CreamSCD9d830535-2202-482d-9d1a-bccd7bbba8552
311500menthol 10 % / methyl salicylate 30 % Topical CreamSYb2619163-01c4-4104-a40c-ee36e814e0c82
311500menthol 10 % / methyl salicylate 30 % Topical CreamSY9d830535-2202-482d-9d1a-bccd7bbba8552
311500menthol 10 % / methyl salicylate 30 % Topical CreamPSN793d6fad-31a7-4b28-8395-73825bc185081
311500menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical CreamSCD793d6fad-31a7-4b28-8395-73825bc185081
311500menthol 10 % / methyl salicylate 30 % Topical CreamSY793d6fad-31a7-4b28-8395-73825bc185081

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
69837-019-01698370019011 in 1 CARTONHistorical
69837-019-0269837001902118 g in 1 TUBE118 gHistorical