FDA.reportPublic FDA data

Advanced relief

Product NDC
41520-532
Requested package NDC
41520-532-05
11-digit product format
415200532
Labeler code
41520
Product ID
41520-532_961038fc-fff0-2300-e053-2995a90a8dc1
Type
HUMAN OTC DRUG
Nonproprietary name
dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline HCl
Dosage form
LIQUID
Route
OPHTHALMIC
Labeler
American Sales Company
Application
part349
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-09-07
Marketing end
0000-00-00
Substance
TETRAHYDROZOLINE HYDROCHLORIDE; DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE
Active strength
1 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTRAN 70ACTIVE INGREDIENT7SA290YK68ADVANCED RELIEF (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) LIQUID [AMERICAN SALES COMPANY]1
POLYETHYLENE GLYCOL 400ACTIVE INGREDIENTB697894SGQADVANCED RELIEF (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) LIQUID [AMERICAN SALES COMPANY]1
POVIDONEACTIVE INGREDIENTFZ989GH94EADVANCED RELIEF (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) LIQUID [AMERICAN SALES COMPANY]1
TETRAHYDROZOLINE HYDROCHLORIDEACTIVE INGREDIENT0YZT43HS7DADVANCED RELIEF (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) LIQUID [AMERICAN SALES COMPANY]1
DEXTRAN 70ACTIVE MOIETY7SA290YK68ADVANCED RELIEF (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) LIQUID [AMERICAN SALES COMPANY]1
POLYETHYLENE GLYCOL 400ACTIVE MOIETYB697894SGQADVANCED RELIEF (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) LIQUID [AMERICAN SALES COMPANY]1
POVIDONEACTIVE MOIETYFZ989GH94EADVANCED RELIEF (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) LIQUID [AMERICAN SALES COMPANY]1
TETRAHYDROZOLINEACTIVE MOIETYS9U025Y077ADVANCED RELIEF (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) LIQUID [AMERICAN SALES COMPANY]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7ADVANCED RELIEF (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) LIQUID [AMERICAN SALES COMPANY]1
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4ADVANCED RELIEF (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) LIQUID [AMERICAN SALES COMPANY]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KADVANCED RELIEF (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) LIQUID [AMERICAN SALES COMPANY]1
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QOADVANCED RELIEF (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) LIQUID [AMERICAN SALES COMPANY]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XADVANCED RELIEF (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) LIQUID [AMERICAN SALES COMPANY]1
WATERINACTIVE INGREDIENT059QF0KO0RADVANCED RELIEF (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) LIQUID [AMERICAN SALES COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-532ADVANCED RELIEF (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) LIQUID [AMERICAN SALES COMPANY]5Legacy NDC20250104_806197fc-5d1f-4e88-b6f2-76034042cac8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-532-05415200532051 BOTTLE in 1 BOX (41520-532-05) > 15 mL in 1 BOTTLE1 bottle2011-09-110000-00-00NoNoCurrent