Artificial Tears

Product NDC
55651-008
11-digit product format
556510008
Labeler code
55651
Product ID
55651-008_4748d0f4-e97c-a0c1-e063-6394a90ac311
Type
HUMAN OTC DRUG
Nonproprietary name
polyvinyl alcohol, povidone
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
KC Pharmaceuticals, Inc.
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2003-11-25
Substance
POLYVINYL ALCOHOL, UNSPECIFIED; POVIDONE, UNSPECIFIED
Active strength
5; 6 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Artificial Tears
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POLYVINYL ALCOHOL, UNSPECIFIED5 mg/mL
POVIDONE, UNSPECIFIED6 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii532B59J990, FZ989GH94E
Rxcui598050

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
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
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
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
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
55651-008-01Artificial Tears15 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS154
55651-008-01Artificial Tears1 in 1 CARTONSOLUTION/ DROPS14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POLYVINYL ALCOHOLACTIVE INGREDIENT532B59J990ARTIFICIAL TEARS (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]1
POVIDONEACTIVE INGREDIENTFZ989GH94EARTIFICIAL TEARS (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]1
POLYVINYL ALCOHOLACTIVE MOIETY532B59J990ARTIFICIAL TEARS (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]1
POVIDONEACTIVE MOIETYFZ989GH94EARTIFICIAL TEARS (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7ARTIFICIAL TEARS (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]1
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2ARTIFICIAL TEARS (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KARTIFICIAL TEARS (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]1
POTASSIUM CHLORIDEINACTIVE INGREDIENT660YQ98I10ARTIFICIAL TEARS (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOARTIFICIAL TEARS (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XARTIFICIAL TEARS (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRARTIFICIAL TEARS (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]1
SODIUM PHOSPHATE, DIBASIC ANHYDROUSINACTIVE INGREDIENT22ADO53M6FARTIFICIAL TEARS (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]1
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEINACTIVE INGREDIENT593YOG76RNARTIFICIAL TEARS (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RARTIFICIAL TEARS (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55651-008ARTIFICIAL TEARS (POLYVINYL ALCOHOL, POVIDONE) SOLUTION/ DROPS [KC PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 2 package rows20250101_eb6eb6c4-1609-407b-84e4-c7509811f3c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
598050polyvinyl alcohol 0.5 % / povidone 0.6 % Ophthalmic SolutionPSNeb6eb6c4-1609-407b-84e4-c7509811f3c04
598050polyvinyl alcohol 0.005 ML/ML / povidone 6 MG/ML Ophthalmic SolutionSCDeb6eb6c4-1609-407b-84e4-c7509811f3c04
598050polyvinyl alcohol 0.5 % / povidone 0.6 % Ophthalmic SolutionSYeb6eb6c4-1609-407b-84e4-c7509811f3c04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55651-008-01556510008011 BOTTLE, DROPPER in 1 CARTON (55651-008-01) / 15 mL in 1 BOTTLE, DROPPER2003-11-250000-00-00NoNoCurrent