SoundBody Advanced Relief

Product NDC
65923-637
11-digit product format
659230637
Labeler code
65923
Product ID
65923-637_70332973-4a38-4a69-bab3-18c91a532664
Type
HUMAN OTC DRUG
Nonproprietary name
Dextarn 70, Polyethylene glycol 400, Povidone, Tetrahydrozoline HCI
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
United Exchange Corp.
Application
part349
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-11-25
Marketing end
0000-00-00
Substance
DEXTRAN 70; POLYETHYLENE GLYCOL 400; POVIDONE; TETRAHYDROZOLINE HYDROCHLORIDE
Active strength
1 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
27945931-b6e2-158e-d615-4ef21e2af974Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65923-637-152020-01-31C16284748780-19d75b9d0-0e65-f424-e053-dadaa90a57ce8d6f13bb-0fb6-4e66-8a8b-72612d3aacf2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65923-637-15SoundBody Advanced Relief1 in 1 BOXSOLUTION/ DROPS15
65923-637-15SoundBody Advanced Relief15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS155

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DEXTRAN 70ACTIVE INGREDIENT7SA290YK68SOUNDBODY ADVANCED RELIEF (DEXTARN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCI) SOLUTION/ DROPS [UNITED EXCHANGE CORP.]5
POLYETHYLENE GLYCOL 400ACTIVE INGREDIENTB697894SGQSOUNDBODY ADVANCED RELIEF (DEXTARN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCI) SOLUTION/ DROPS [UNITED EXCHANGE CORP.]5
POVIDONEACTIVE INGREDIENTFZ989GH94ESOUNDBODY ADVANCED RELIEF (DEXTARN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCI) SOLUTION/ DROPS [UNITED EXCHANGE CORP.]5
TETRAHYDROZOLINE HYDROCHLORIDEACTIVE INGREDIENT0YZT43HS7DSOUNDBODY ADVANCED RELIEF (DEXTARN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCI) SOLUTION/ DROPS [UNITED EXCHANGE CORP.]5
DEXTRAN 70ACTIVE MOIETY7SA290YK68SOUNDBODY ADVANCED RELIEF (DEXTARN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCI) SOLUTION/ DROPS [UNITED EXCHANGE CORP.]5
POLYETHYLENE GLYCOL 400ACTIVE MOIETYB697894SGQSOUNDBODY ADVANCED RELIEF (DEXTARN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCI) SOLUTION/ DROPS [UNITED EXCHANGE CORP.]5
POVIDONEACTIVE MOIETYFZ989GH94ESOUNDBODY ADVANCED RELIEF (DEXTARN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCI) SOLUTION/ DROPS [UNITED EXCHANGE CORP.]5
TETRAHYDROZOLINEACTIVE MOIETYS9U025Y077SOUNDBODY ADVANCED RELIEF (DEXTARN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCI) SOLUTION/ DROPS [UNITED EXCHANGE CORP.]5
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7SOUNDBODY ADVANCED RELIEF (DEXTARN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCI) SOLUTION/ DROPS [UNITED EXCHANGE CORP.]5
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4SOUNDBODY ADVANCED RELIEF (DEXTARN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCI) SOLUTION/ DROPS [UNITED EXCHANGE CORP.]5
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KSOUNDBODY ADVANCED RELIEF (DEXTARN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCI) SOLUTION/ DROPS [UNITED EXCHANGE CORP.]5
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QOSOUNDBODY ADVANCED RELIEF (DEXTARN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCI) SOLUTION/ DROPS [UNITED EXCHANGE CORP.]5
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XSOUNDBODY ADVANCED RELIEF (DEXTARN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCI) SOLUTION/ DROPS [UNITED EXCHANGE CORP.]5
WATERINACTIVE INGREDIENT059QF0KO0RSOUNDBODY ADVANCED RELIEF (DEXTARN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCI) SOLUTION/ DROPS [UNITED EXCHANGE CORP.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65923-637SOUNDBODY ADVANCED RELIEF (DEXTARN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCI) SOLUTION/ DROPS [UNITED EXCHANGE CORP.]5Legacy NDC, 2 package rows20141125_8d6f13bb-0fb6-4e66-8a8b-72612d3aacf2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
996202dextran 70 0.1 % / polyethylene glycol 400 1 % / povidone 1 % / tetrahydrozoline HCl 0.05 % Ophthalmic SolutionPSN8d6f13bb-0fb6-4e66-8a8b-72612d3aacf25
996202dextran 70 1 MG/ML / polyethylene glycol 400 10 MG/ML / povidone 10 MG/ML / tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic SolutionSCD8d6f13bb-0fb6-4e66-8a8b-72612d3aacf25
996202dextran 70 0.1 % / polyethylene glycol 400 1 % / povidone 1 % / tetrahydrozoline HCl 0.05 % Ophthalmic SolutionSY8d6f13bb-0fb6-4e66-8a8b-72612d3aacf25

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
65923-637-15659230637151 in 1 BOXHistorical