FDA.reportPublic FDA data

Sync Quadra

Product NDC
82944-500
11-digit product format
829440500
Labeler code
82944
Product ID
82944-500_3b01c59f-9f1a-ccbf-e063-6394a90a80ba
Type
HUMAN OTC DRUG
Nonproprietary name
Methyl salicylate, Menthol, Capsaicin, Methyl nicotinate
Dosage form
PATCH
Route
TOPICAL
Labeler
Ion Pharma, LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-01
Substance
CAPSAICIN; MENTHOL; METHYL NICOTINATE; METHYL SALICYLATE
Active strength
.025; 10; .25; 10 g/1; g/1; g/1; g/1
Pharmacologic classes
Nicotinic Acid [EPC], Nicotinic Acids [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sync Quadra
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAPSAICIN.025 g/1
MENTHOL10 g/1
METHYL NICOTINATE.25 g/1
METHYL SALICYLATE10 g/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiS07O44R1ZM, L7T10EIP3A, 7B1AVU9DJN, LAV5U5022Y
Rxcui2640874

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
e2dae634-14ed-febf-08ee-93196433b5b7Product name920190614
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8Product name120140508
d394f843-7479-dc48-dbd3-232266c5548cProduct name120140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82944-500-10Sync Quadra10 in 1 POUCHPATCH102
82944-500-10Sync Quadra1 in 1 BOXPATCH12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2640874capsaicin 0.025 % / menthol 10 % / methyl salicylate 10 % / methylnicotinate 0.25 % Medicated PatchPSN39af3350-75a8-5f8c-e063-6394a90a6e962
2640874capsaicin 0.00025 MG/MG / menthol 0.1 MG/MG / methyl salicylate 0.1 MG/MG / methylnicotinate 0.0025 MG/MG Medicated PatchSCD39af3350-75a8-5f8c-e063-6394a90a6e962
2640874capsaicin 0.025 % / menthol 10 % / methyl salicylate 10 % / methylnicotinate 0.25 % Medicated PatchSY39af3350-75a8-5f8c-e063-6394a90a6e962

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82944-500-10829440500101 POUCH in 1 BOX (82944-500-10) / 10 PATCH in 1 POUCH / 1 PATCH in 1 PATCH1 pouch2025-04-01NoNoCurrent