FDA.reportPublic FDA data

Artificial Tears Lubricant Eye Drops

Product NDC
69842-454
11-digit product format
698420454
Labeler code
69842
Product ID
69842-454_4f5f11ed-66ec-7b64-e063-6294a90affb3
Type
HUMAN OTC DRUG
Nonproprietary name
glycerin, propylene glycol
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
CVS Pharmacy
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-09-01
Substance
GLYCERIN; PROPYLENE GLYCOL
Active strength
3; 10 mg/mL; mg/mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Artificial Tears Lubricant Eye Drops
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCERIN3 mg/mL
PROPYLENE GLYCOL10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PDC6A3C0OXInternal UNII lookup
6DC9Q167V3Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
259195Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
28297fee-8185-4869-8f39-5bfbf8bf8bfdAvailable on FDA.report

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
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
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
69842-454-15Artificial Tears Lubricant Eye Drops15 mL in 1 BOTTLESOLUTION/ DROPS157
69842-454-15Artificial Tears Lubricant Eye Drops1 in 1 CARTONSOLUTION/ DROPS17
69842-454-30Artificial Tears Lubricant Eye Drops30 mL in 1 BOTTLESOLUTION/ DROPS307
69842-454-30Artificial Tears Lubricant Eye Drops1 in 1 CARTONSOLUTION/ DROPS17
69842-454-45Artificial Tears Lubricant Eye Drops15 mL in 1 BOTTLESOLUTION/ DROPS157
69842-454-45Artificial Tears Lubricant Eye Drops2 in 1 CARTONSOLUTION/ DROPS27

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-454ARTIFICIAL TEARS LUBRICANT EYE DROPS (GLYCERIN, PROPYLENE GLYCOL) SOLUTION/ DROPS [CVS PHARMACY]4Current NDC, Legacy NDC, 6 package rows20241012_28297fee-8185-4869-8f39-5bfbf8bf8bfd.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 25 of 25 · 486 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
REFRESH TEARSCARBOXYMETHYLCELLULOSE SODIUMAllergan, Inc.329d1fe0-4432-4565-b7b1-65666bd865262022-06-30WarningsExact identifier
application number: M018
REFRESH Optive Mega-3CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.c5f2b3f2-2071-45bd-a010-67f848bc02332022-06-30WarningsExact identifier
application number: M018
REFRESH P.M.MINERAL OIL, PETROLATUMAllergan, Inc.24365d64-cd94-41cc-a7e1-033102d981142022-06-30WarningsExact identifier
application number: M018
REFRESH PLUSCARBOXYMETHYLCELLULOSE SODIUMAllergan, Inc.0f6a4b4b-cde6-4518-84b5-ce997f1154a72022-06-28WarningsExact identifier
application number: M018
CIRCLE K sterile eye dropsTETRAHYDROZOLINE HCLLil' Drug Store Products, Inc.2c0e106c-16f6-ff4e-e063-6294a90a7dbb2018-07-30WarningsExact identifier
application number: M018
Lil Drug Store Sterile Eye Drops Redness RelieverTETRAHYDROZOLINE HCLLil' Drug Store Products, Inc.2c0ea35c-ac52-1043-e063-6394a90a061c2018-04-30WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259195glycerin 0.3 % / propylene glycol 1 % Ophthalmic SolutionPSN28297fee-8185-4869-8f39-5bfbf8bf8bfd7
259195glycerin 3 MG/ML / propylene glycol 10 MG/ML Ophthalmic SolutionSCD28297fee-8185-4869-8f39-5bfbf8bf8bfd7
259195glycerin 0.3 % / propylene glycol 1 % Ophthalmic SolutionSY28297fee-8185-4869-8f39-5bfbf8bf8bfd7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-454-15698420454151 BOTTLE in 1 CARTON (69842-454-15) / 15 mL in 1 BOTTLE1 bottle2026-04-09NoNoCurrent
69842-454-30698420454301 BOTTLE in 1 CARTON (69842-454-30) / 30 mL in 1 BOTTLE1 bottle2010-09-010000-00-00NoNoCurrent
69842-454-45698420454452 BOTTLE in 1 CARTON (69842-454-45) / 15 mL in 1 BOTTLE2 bottle2026-04-09NoNoCurrent