Artificial Tears Lubricant Eye

Product NDC
67091-284
11-digit product format
670910284
Labeler code
67091
Product ID
67091-284_99044b03-0baa-2697-e053-2a95a90a3d38
Type
HUMAN OTC DRUG
Nonproprietary name
polyvinyl alcohol, povidone
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
WinCo Foods, LLC
Application
part349
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-01-09
Marketing end
0000-00-00
Substance
POLYVINYL ALCOHOL; POVIDONE
Active strength
500 mg/100mL; mg/100mL
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67091-284IInactivated by FDA2026-09-14
excluded packagepackage67091-28467091-284-15IInactivated by FDA2026-09-14

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
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
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67091-284-15Winco Artificial Tears Lubricant Eye Drops15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS153
67091-284-15Winco Artificial Tears Lubricant Eye Drops1 in 1 BOXSOLUTION/ DROPS13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POLYVINYL ALCOHOLACTIVE INGREDIENT532B59J990ARTIFICIAL TEARS LUBRICANT EYE (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [WINCO FOODS, LLC]1
POVIDONEACTIVE INGREDIENTFZ989GH94EARTIFICIAL TEARS LUBRICANT EYE (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [WINCO FOODS, LLC]1
POLYVINYL ALCOHOLACTIVE MOIETY532B59J990ARTIFICIAL TEARS LUBRICANT EYE (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [WINCO FOODS, LLC]1
POVIDONEACTIVE MOIETYFZ989GH94EARTIFICIAL TEARS LUBRICANT EYE (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [WINCO FOODS, LLC]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7ARTIFICIAL TEARS LUBRICANT EYE (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [WINCO FOODS, LLC]1
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2ARTIFICIAL TEARS LUBRICANT EYE (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [WINCO FOODS, LLC]1
edetate disodiumINACTIVE INGREDIENT7FLD91C86KARTIFICIAL TEARS LUBRICANT EYE (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [WINCO FOODS, LLC]1
POTASSIUM CHLORIDEINACTIVE INGREDIENT660YQ98I10ARTIFICIAL TEARS LUBRICANT EYE (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [WINCO FOODS, LLC]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOARTIFICIAL TEARS LUBRICANT EYE (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [WINCO FOODS, LLC]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XARTIFICIAL TEARS LUBRICANT EYE (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [WINCO FOODS, LLC]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRARTIFICIAL TEARS LUBRICANT EYE (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [WINCO FOODS, LLC]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74ARTIFICIAL TEARS LUBRICANT EYE (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [WINCO FOODS, LLC]1
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWARTIFICIAL TEARS LUBRICANT EYE (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [WINCO FOODS, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RARTIFICIAL TEARS LUBRICANT EYE (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [WINCO FOODS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67091-284WINCO ARTIFICIAL TEARS LUBRICANT EYE DROPS (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [WINCO FOODS, LLC]3Legacy NDC, 2 package rows20240111_7fc30d40-4742-45f0-bf3f-7532f68fd815.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
598050polyvinyl alcohol 0.5 % / povidone 0.6 % Ophthalmic SolutionPSN7fc30d40-4742-45f0-bf3f-7532f68fd8153
598050polyvinyl alcohol 0.005 ML/ML / povidone 6 MG/ML Ophthalmic SolutionSCD7fc30d40-4742-45f0-bf3f-7532f68fd8153
598050polyvinyl alcohol 0.5 % / povidone 0.6 % Ophthalmic SolutionSY7fc30d40-4742-45f0-bf3f-7532f68fd8153

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67091-284-15670910284151 BOTTLE, DROPPER in 1 BOX (67091-284-15) > 15 mL in 1 BOTTLE, DROPPER2015-01-090000-00-00NoNoCurrent