FDA.reportPublic FDA data

Silvera Pain Relief Patch

Product NDC
69379-037
11-digit product format
693790037
Labeler code
69379
Product ID
69379-037_093edffd-e151-5f8e-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Silvera Pain Relief Patch
Dosage form
PATCH
Route
TOPICAL
Labeler
Home Aide Diagnostics, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2014-11-18
Marketing end
0000-00-00
Substance
LIDOCAINE; CAPSAICIN; MENTHOL
Active strength
1 g/100g; g/100g; g/100g
Pharmacologic classes
Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE]
NDC exclude flag
E
Listing certified through
2017-12-31
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
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69379-037-152020-01-31C16284748780-19d75b9cf-e32d-f424-e053-dadaa90a57ceSILVERA PAIN RELIEF PATCH
69379-037-162020-01-31C16284748780-19d75b9cf-e32d-f424-e053-dadaa90a57ceSILVERA PAIN RELIEF PATCH
69379-037-172020-01-31C16284748780-19d75b9cf-e32d-f424-e053-dadaa90a57ceSILVERA PAIN RELIEF PATCH
69379-037-202020-01-31C16284748780-19d75b9cf-ee3d-f424-e053-dadaa90a57ceSilvera External Pain Relief Patch

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69379-037-15Silvera Pain Relief Patch100 g in 1 PACKAGEPATCH1001
69379-037-16Silvera Pain Relief Patch3 in 1 PACKAGEPATCH31
69379-037-16Silvera Pain Relief Patch15 in 1 BOXPATCH151
69379-037-17Silvera Pain Relief Patch5 in 1 BOXPATCH51
69379-037-17Silvera Pain Relief Patch3 in 1 PACKAGEPATCH31
69379-037-20Silvera Pain Relief Patch3 in 1 PACKAGEPATCH31
69379-037-20Silvera Pain Relief Patch5 in 1 BOXPATCH51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69379-037-17EA - Each69379-037d1535bf1-ff01-4c32-a2e4-5b34e052c96512015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CapsaicinACTIVE INGREDIENTS07O44R1ZMSILVERA PAIN RELIEF PATCH PATCH [HOME AIDE DIAGNOSTICS, INC.]1
CAPSAICINACTIVE INGREDIENTS07O44R1ZMSILVERA PAIN RELIEF PATCH PATCH [HOME AIDE DIAGNOSTICS, INC.]1
LidocaineACTIVE INGREDIENT98PI200987SILVERA PAIN RELIEF PATCH PATCH [HOME AIDE DIAGNOSTICS, INC.]1
LIDOCAINEACTIVE INGREDIENT98PI200987SILVERA PAIN RELIEF PATCH PATCH [HOME AIDE DIAGNOSTICS, INC.]1
MentholACTIVE INGREDIENTL7T10EIP3ASILVERA PAIN RELIEF PATCH PATCH [HOME AIDE DIAGNOSTICS, INC.]1
MENTHOLACTIVE INGREDIENTL7T10EIP3ASILVERA PAIN RELIEF PATCH PATCH [HOME AIDE DIAGNOSTICS, INC.]1
CapsaicinACTIVE MOIETYS07O44R1ZMSILVERA PAIN RELIEF PATCH PATCH [HOME AIDE DIAGNOSTICS, INC.]1
CAPSAICINACTIVE MOIETYS07O44R1ZMSILVERA PAIN RELIEF PATCH PATCH [HOME AIDE DIAGNOSTICS, INC.]1
LidocaineACTIVE MOIETY98PI200987SILVERA PAIN RELIEF PATCH PATCH [HOME AIDE DIAGNOSTICS, INC.]1
LIDOCAINEACTIVE MOIETY98PI200987SILVERA PAIN RELIEF PATCH PATCH [HOME AIDE DIAGNOSTICS, INC.]1
MentholACTIVE MOIETYL7T10EIP3ASILVERA PAIN RELIEF PATCH PATCH [HOME AIDE DIAGNOSTICS, INC.]1
MENTHOLACTIVE MOIETYL7T10EIP3ASILVERA PAIN RELIEF PATCH PATCH [HOME AIDE DIAGNOSTICS, INC.]1
BORNEOLINACTIVE INGREDIENTM89NIB437XSILVERA PAIN RELIEF PATCH PATCH [HOME AIDE DIAGNOSTICS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69379-037SILVERA PAIN RELIEF PATCH PATCH [HOME AIDE DIAGNOSTICS, INC.]1Legacy NDC, 2 package rows20150528_17261c31-21aa-5e21-e054-00144ff88e88.zip
69379-037SILVERA PAIN RELIEF PATCH PATCH [HOME AIDE DIAGNOSTICS, INC.]1Legacy NDC, 5 package rows20141202_093edffd-e150-5f8e-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1608258capsaicin 0.0375 % / lidocaine 1 % / menthol 5 % Medicated PatchPSN093edffd-e150-5f8e-e054-00144ff8d46c1
1608258capsaicin 0.0375 % / lidocaine 1 % / menthol 5 % Medicated PatchPSN17261c31-21aa-5e21-e054-00144ff88e881
1608258capsaicin 0.000375 MG/MG / lidocaine 0.01 MG/MG / menthol 0.05 MG/MG Medicated PatchSCD093edffd-e150-5f8e-e054-00144ff8d46c1
1608258capsaicin 0.000375 MG/MG / lidocaine 0.01 MG/MG / menthol 0.05 MG/MG Medicated PatchSCD17261c31-21aa-5e21-e054-00144ff88e881
1608258capsaicin 0.0375 % / lidocaine 1 % / menthol 5 % Medicated PatchSY093edffd-e150-5f8e-e054-00144ff8d46c1
1608258capsaicin 0.0375 % / lidocaine 1 % / menthol 5 % Medicated PatchSY17261c31-21aa-5e21-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
69379-037-1569379003715100 g in 1 PACKAGE100 gHistorical
69379-037-16693790037163 in 1 PACKAGEHistorical
69379-037-17693790037175 in 1 BOXHistorical
69379-037-20693790037203 in 1 PACKAGEHistorical