FDA.reportPublic FDA data

Optimis7

Product NDC
58697-064
11-digit product format
586970064
Labeler code
58697
Product ID
58697-064_2d80ae24-1f9c-43d2-e054-00144ff88e88
Type
HUMAN OTC DRUG
Nonproprietary name
dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline HCl
Dosage form
LIQUID
Route
OPHTHALMIC
Labeler
Pacific Health Collaborative, Inc.
Application
part349
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-08-11
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
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
58697-064-052020-01-31C16284748780-19d75b9d0-31ea-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58697-064-05Optimis71 in 1 BOXLIQUID11
58697-064-05Optimis715 mL in 1 BOTTLELIQUID151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58697-064OPTIMIS7 (DEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL) LIQUID [PACIFIC HEALTH COLLABORATIVE, INC.]1Legacy NDC, 2 package rows20160308_2d80ae24-1f9b-43d2-e054-00144ff88e88.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 SolutionPSN2d80ae24-1f9b-43d2-e054-00144ff88e881
1741538Optimis7 (0.1 % / 1 % / 1 % / 0.05 % ) Ophthalmic SolutionPSN2d80ae24-1f9b-43d2-e054-00144ff88e881
1741538dextran 70 1 MG/ML / polyethylene glycol 400 10 MG/ML / povidone 10 MG/ML / tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic Solution [Optimis7]SBD2d80ae24-1f9b-43d2-e054-00144ff88e881
996202dextran 70 1 MG/ML / polyethylene glycol 400 10 MG/ML / povidone 10 MG/ML / tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic SolutionSCD2d80ae24-1f9b-43d2-e054-00144ff88e881
996202dextran 70 0.1 % / polyethylene glycol 400 1 % / povidone 1 % / tetrahydrozoline HCl 0.05 % Ophthalmic SolutionSY2d80ae24-1f9b-43d2-e054-00144ff88e881
1741538Optimis7 (dextran 70 0.1 % / polyethylene glycol 400 1 % / povidone 1 % / tetrahydrozoline HCl 0.05 % ) Ophthalmic SolutionSY2d80ae24-1f9b-43d2-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
58697-064-05586970064051 in 1 BOXHistorical