Soundbody Seasonal itchy and Red eye relief

Product NDC
67510-0651
11-digit product format
675100651
Labeler code
67510
Product ID
67510-0651_e3575286-2db2-d528-e053-2a95a90a19a8
Type
HUMAN OTC DRUG
Nonproprietary name
tetrahydrozoline HCl, Zinc sulfate
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
TETRAHYDROZOLINE HYDROCHLORIDE; ZINC SULFATE
Active strength
0 mg/mL; mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
27945931-b6e2-158e-d615-4ef21e2af974Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67510-0651-52024-01-30C16284748780-11030e365-4186-111a-e063-dadaa90a10e2Soundbody Eye drops Seasonal Itchy & Red Eye Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67510-0651-5Soundbody Seasonal itchy and Red eye relief15 mL in 1 BOTTLELIQUID153
67510-0651-5Soundbody Seasonal itchy and Red eye relief1 in 1 CARTONLIQUID13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67510-0651SOUNDBODY SEASONAL ITCHY AND RED EYE RELIEF (TETRAHYDROZOLINE HCL, ZINC SULFATE) LIQUID [KAREWAY PRODUCT, INC.]3Legacy NDC, 2 package rows20220710_6d87f1d6-1c8e-778a-e053-2991aa0aaa23.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67510-0651-5675100651051 BOTTLE in 1 CARTON (67510-0651-5) > 15 mL in 1 BOTTLE1 bottle2018-05-300000-00-00NoNoCurrent