FDA.reportPublic FDA data

QUALITY CHOICE LUBRICANT EYE

Product NDC
63868-968
11-digit product format
638680968
Labeler code
63868
Product ID
63868-968_0e4d5583-a1fa-4792-b8af-7a7846d8bec9
Type
HUMAN OTC DRUG
Nonproprietary name
POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
CHAIN DRUG MARKETING ASSOCIATION INC
Application
part349
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-09-30
Marketing end
0000-00-00
Substance
POLYETHYLENE GLYCOL 400; PROPYLENE GLYCOL
Active strength
4 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
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-968-152020-01-31C16284748780-19d75b9d0-0f4f-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-968-15QUALITY CHOICE LUBRICANT EYE15 mL in 1 BOTTLESOLUTION/ DROPS152
63868-968-15QUALITY CHOICE LUBRICANT EYE1 in 1 CARTONSOLUTION/ DROPS12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POLYETHYLENE GLYCOL 400ACTIVE INGREDIENTB697894SGQQUALITY CHOICE LUBRICANT EYE (POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL) SOLUTION/ DROPS [CHAIN DRUG MARKETING ASSOCIATION INC]2
PROPYLENE GLYCOLACTIVE INGREDIENT6DC9Q167V3QUALITY CHOICE LUBRICANT EYE (POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL) SOLUTION/ DROPS [CHAIN DRUG MARKETING ASSOCIATION INC]2
POLYETHYLENE GLYCOL 400ACTIVE MOIETYB697894SGQQUALITY CHOICE LUBRICANT EYE (POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL) SOLUTION/ DROPS [CHAIN DRUG MARKETING ASSOCIATION INC]2
PROPYLENE GLYCOLACTIVE MOIETY6DC9Q167V3QUALITY CHOICE LUBRICANT EYE (POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL) SOLUTION/ DROPS [CHAIN DRUG MARKETING ASSOCIATION INC]2
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4QUALITY CHOICE LUBRICANT EYE (POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL) SOLUTION/ DROPS [CHAIN DRUG MARKETING ASSOCIATION INC]2
CALCIUM CHLORIDEINACTIVE INGREDIENTM4I0D6VV5MQUALITY CHOICE LUBRICANT EYE (POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL) SOLUTION/ DROPS [CHAIN DRUG MARKETING ASSOCIATION INC]2
CHLORHEXIDINE GLUCONATEINACTIVE INGREDIENTMOR84MUD8EQUALITY CHOICE LUBRICANT EYE (POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL) SOLUTION/ DROPS [CHAIN DRUG MARKETING ASSOCIATION INC]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBQUALITY CHOICE LUBRICANT EYE (POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL) SOLUTION/ DROPS [CHAIN DRUG MARKETING ASSOCIATION INC]2
MAGNESIUM CHLORIDEINACTIVE INGREDIENT02F3473H9OQUALITY CHOICE LUBRICANT EYE (POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL) SOLUTION/ DROPS [CHAIN DRUG MARKETING ASSOCIATION INC]2
POTASSIUM CHLORIDEINACTIVE INGREDIENT660YQ98I10QUALITY CHOICE LUBRICANT EYE (POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL) SOLUTION/ DROPS [CHAIN DRUG MARKETING ASSOCIATION INC]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XQUALITY CHOICE LUBRICANT EYE (POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL) SOLUTION/ DROPS [CHAIN DRUG MARKETING ASSOCIATION INC]2
WATERINACTIVE INGREDIENT059QF0KO0RQUALITY CHOICE LUBRICANT EYE (POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL) SOLUTION/ DROPS [CHAIN DRUG MARKETING ASSOCIATION INC]2
ZINC CHLORIDEINACTIVE INGREDIENT86Q357L16BQUALITY CHOICE LUBRICANT EYE (POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL) SOLUTION/ DROPS [CHAIN DRUG MARKETING ASSOCIATION INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-968QUALITY CHOICE LUBRICANT EYE (POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL) SOLUTION/ DROPS [CHAIN DRUG MARKETING ASSOCIATION INC]2Legacy NDC, 2 package rows20121013_a829b0de-65dd-4e60-8090-64d0a064df32.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
477589polyethylene glycol 400, 0.4 % / propylene glycol 0.3 % Ophthalmic SolutionPSNa829b0de-65dd-4e60-8090-64d0a064df322
477589polyethylene glycol 400 4 MG/ML / propylene glycol 3 MG/ML Ophthalmic SolutionSCDa829b0de-65dd-4e60-8090-64d0a064df322
477589PEG 400 0.4 % / propylene glycol 0.3 % Ophthalmic SolutionSYa829b0de-65dd-4e60-8090-64d0a064df322

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
63868-968-156386809681515 mL in 1 BOTTLE15 mlHistorical