Soundbody Advanced relief

Product NDC
67510-0652
11-digit product format
675100652
Labeler code
67510
Product ID
67510-0652_e3575e0b-76d2-83a7-e053-2a95a90a5409
Type
HUMAN OTC DRUG
Nonproprietary name
dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline HCl
Dosage form
LIQUID
Route
OPHTHALMIC
Labeler
Kareway Product, Inc.
Application
part349
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2018-05-30
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
Pharmacologic classes
Increased Intravascular Volume [PE], Osmotic Activity [MoA], Plasma Volume Expander [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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
67510-0652-52024-01-30C16284748780-11030e365-6cb7-111a-e063-dadaa90a10e2Soundbody Advanced Relief Eye Drops

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67510-0652-5Soundbody Advanced relief15 mL in 1 BOTTLELIQUID153
67510-0652-5Soundbody Advanced relief1 in 1 BOXLIQUID13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67510-0652SOUNDBODY ADVANCED RELIEF (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) LIQUID [KAREWAY PRODUCT, INC.]3Legacy NDC, 2 package rows20220710_6d88761a-b765-b938-e053-2a91aa0a7625.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67510-0652-5675100652051 BOTTLE in 1 BOX (67510-0652-5) > 15 mL in 1 BOTTLE1 bottle2018-05-300000-00-00NoNoCurrent