FDA.reportPublic FDA data

Artifical Tears

Product NDC
49035-454
11-digit product format
490350454
Labeler code
49035
Product ID
49035-454_5ce0e2fd-1e13-2114-e063-6394a90ac022
Type
HUMAN OTC DRUG
Nonproprietary name
Glycerin and Propylene Glycol
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Wal-Mart Stores Inc
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
Artifical Tears
Listing expiration
2027-12-31

Active Ingredients#

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

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
49035-454-15Artifical Tears1 in 1 CARTONSOLUTION/ DROPS18
49035-454-15Artifical Tears15 mL in 1 BOTTLESOLUTION/ DROPS158
49035-454-30Artifical Tears30 mL in 1 BOTTLESOLUTION/ DROPS308
49035-454-30Artifical Tears1 in 1 CARTONSOLUTION/ DROPS18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-454-15ML - Milliliter49035-45445864127-b36b-4899-a992-cc73d3fb755912013-05-02
49035-454-30ML - Milliliter49035-4545e232964-1a2b-4377-97b6-b2223929c74b12020-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLYCERINACTIVE INGREDIENTPDC6A3C0OXARTIFICAL TEARS (GLYCERIN AND PROPYLENE GLYCOL) SOLUTION/ DROPS [WAL-MART STORES INC]2
PROPYLENE GLYCOLACTIVE INGREDIENT6DC9Q167V3ARTIFICAL TEARS (GLYCERIN AND PROPYLENE GLYCOL) SOLUTION/ DROPS [WAL-MART STORES INC]2
GLYCERINACTIVE MOIETYPDC6A3C0OXARTIFICAL TEARS (GLYCERIN AND PROPYLENE GLYCOL) SOLUTION/ DROPS [WAL-MART STORES INC]2
PROPYLENE GLYCOLACTIVE MOIETY6DC9Q167V3ARTIFICAL TEARS (GLYCERIN AND PROPYLENE GLYCOL) SOLUTION/ DROPS [WAL-MART STORES INC]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7ARTIFICAL TEARS (GLYCERIN AND PROPYLENE GLYCOL) SOLUTION/ DROPS [WAL-MART STORES INC]2
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4ARTIFICAL TEARS (GLYCERIN AND PROPYLENE GLYCOL) SOLUTION/ DROPS [WAL-MART STORES INC]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KARTIFICAL TEARS (GLYCERIN AND PROPYLENE GLYCOL) SOLUTION/ DROPS [WAL-MART STORES INC]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBARTIFICAL TEARS (GLYCERIN AND PROPYLENE GLYCOL) SOLUTION/ DROPS [WAL-MART STORES INC]2
POTASSIUM CHLORIDEINACTIVE INGREDIENT660YQ98I10ARTIFICAL TEARS (GLYCERIN AND PROPYLENE GLYCOL) SOLUTION/ DROPS [WAL-MART STORES INC]2
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QOARTIFICAL TEARS (GLYCERIN AND PROPYLENE GLYCOL) SOLUTION/ DROPS [WAL-MART STORES INC]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XARTIFICAL TEARS (GLYCERIN AND PROPYLENE GLYCOL) SOLUTION/ DROPS [WAL-MART STORES INC]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IARTIFICAL TEARS (GLYCERIN AND PROPYLENE GLYCOL) SOLUTION/ DROPS [WAL-MART STORES INC]2
WATERINACTIVE INGREDIENT059QF0KO0RARTIFICAL TEARS (GLYCERIN AND PROPYLENE GLYCOL) SOLUTION/ DROPS [WAL-MART STORES INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-454ARTIFICAL TEARS (GLYCERIN AND PROPYLENE GLYCOL) SOLUTION/ DROPS [WAL-MART STORES INC]7Current NDC, Legacy NDC, 4 package rows20241012_99cfea82-afb8-4c5f-ac0c-492204a42c08.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 16 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Systane COMPLETE PFPROPYLENE GLYCOLAlcon Laboratories, Inc.99b63d62-1cf0-4f28-8760-773917c2538a2025-07-29WarningsExact identifier
application number: M018
LubriFresh PMLIGHT MINERAL OIL, WHITE PETROLATUMMajor Pharmaceuticals3ab32e69-b8da-f187-e063-6294a90afa9a2025-07-24WarningsExact identifier
application number: M018
Rugby Polyvinyl Alcohol 1.4% Lubricating Eye DropsPOLYVINYL ALCOHOLA-S Medication Solutions2653e4fc-4f08-426d-a0a4-31d647c1de562025-07-18WarningsExact identifier
application number: M018
Focus Tears PFCARBOXYMETHYLCELLULOSE SODIUMCovalent Medical772c7070-82ff-4371-b071-940ff91372c62025-07-17WarningsExact identifier
application number: M018
SilkTearsGLYCERIN OPHTHALMIC SOLUTIONSilkTears3866e2c1-051b-0b01-e063-6394a90af5cf2025-07-16WarningsExact identifier
application number: M018
Eyeleve MGDMINERAL OILBruder Healthcare145b66e2-00e1-410e-8539-e12ffc4f6f822025-07-15WarningsExact identifier
application number: M018
Quality Choice Eye Drops Redness ReliefTETRAHYDROZOLINE HCLChain Drug Marketing Assoc., Inc.38d2bc34-c6f0-a09c-e063-6394a90a69e12025-06-26WarningsExact identifier
application number: M018
Visine Red Eye Hydrating Comfort Eye DropsTETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400Morning Star OTCdcd4164c-aa1e-4f07-ab2c-b439275629db2025-06-16WarningsExact identifier
application number: M018
Code Red Eye Drops MicroGLYCERIN AND NAPHAZOLINE HYDROCHLORIDE4 Trees LLC2a15ea9a-ff67-446b-8b83-6517d25ff38a2025-05-29WarningsExact identifier
application number: M018
Biotrue Hydration BoostGLYCERINBausch & Lomb Incorporatede2621477-e6ee-4275-ba0a-939dca2550c42025-05-19WarningsExact identifier
application number: M018
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
application number: M018
Splash Redness RelieverHYPROMELLOSE, NAPHAZOLINE HYDROCHLORIDELABORATORIOS SOPHIA, S.A. DE C.V.fa4140e6-dc80-da99-e053-6294a90a194f2025-05-09WarningsExact identifier
application number: M018
Vista Gonio Eye LubricantHYPROMELLOSE OPHTHALMIC SOLUTIONRed Wedding LLC00da365d-2988-9c9e-e063-6294a90a89312025-03-25WarningsExact identifier
application number: M018
Sodium ChlorideSODIUM CHLORIDE TABLETBelleview Bioscience LLC31195e8f-d4de-9e37-e063-6294a90a41562025-03-24WarningsExact identifier
application number: M018
Leader Nighttime Relief Lubricant EyeLIGHT MINERAL OIL, WHITE PETROLATUMLEADER/Cardinal Health 110, Inc.308772fc-d6f6-da9f-e063-6394a90a41db2025-03-12WarningsExact identifier
application number: M018
Clear Eyes Maximum Redness ReliefNAPHAZOLINE HYDROCHLORIDE AND GLYCERINPrestige Brands Holdings, Inc.c3b0e344-68dd-4c35-bf46-744e612a5b152025-02-28WarningsExact identifier
application number: M018
Blink Nourish Dry EyeGLYCERINBausch & Lomb Incorporatedcf2b4e19-af0a-472e-9a2d-9b4fa3e9c9a42025-02-25WarningsExact identifier
application number: M018
Advanced Eye Relief Eye WashWATER SOLUTIONBausch & Lomb Incorporated9caccce1-4530-441d-bf76-244edeb9dedc2025-02-17WarningsExact identifier
application number: M018
Hydropure Lubricating Eye DropsGLYCERINOTE North America17f5b6e5-dc14-45c7-e063-6294a90af43d2025-02-14WarningsExact identifier
application number: M018
Walgreens Soothing Eye Relief Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEWalgreens Co.29b7387b-ad65-3a11-e063-6394a90a6a152025-02-14WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259195glycerin 0.3 % / propylene glycol 1 % Ophthalmic SolutionPSN99cfea82-afb8-4c5f-ac0c-492204a42c088
259195glycerin 3 MG/ML / propylene glycol 10 MG/ML Ophthalmic SolutionSCD99cfea82-afb8-4c5f-ac0c-492204a42c088
259195glycerin 0.3 % / propylene glycol 1 % Ophthalmic SolutionSY99cfea82-afb8-4c5f-ac0c-492204a42c088

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-454-15490350454151 BOTTLE in 1 CARTON (49035-454-15) / 15 mL in 1 BOTTLE1 bottle2010-09-010000-00-00NoNoCurrent
49035-454-30490350454301 BOTTLE in 1 CARTON (49035-454-30) / 30 mL in 1 BOTTLE1 bottle2017-05-312028-01-01NoNoCurrent