Artificial Tears

Product NDC
41520-865
Requested package NDC
41520-865-05
11-digit product format
415200865
Labeler code
41520
Product ID
41520-865_9602d650-fc3f-0931-e053-2995a90a8058
Type
HUMAN OTC DRUG
Nonproprietary name
glycerin, hypromellose, polyethylene glycol 400
Dosage form
LIQUID
Route
OPHTHALMIC
Labeler
American Sales Company
Application
part349
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-09-06
Marketing end
0000-00-00
Substance
GLYCERIN; POLYETHYLENE GLYCOL 400; HYPROMELLOSES
Active strength
2 mg/mL; mg/mL; mg/mL
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage41520-86541520-865-05IInactivated by FDA2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

Reported adverse events (FAERS/openFDA)#

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

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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
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
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct 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
41520-865-052022-01-28C16284748780-1d6a99b39-6aff-a426-e053-dadaa90af4c2CareOne Artificial Tears

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-865-05Artificial Tears15 mL in 1 BOTTLELIQUID154
41520-865-05Artificial Tears1 in 1 BOXLIQUID14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GLYCERINACTIVE INGREDIENTPDC6A3C0OXARTIFICIAL TEARS (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400) LIQUID [AMERICAN SALES COMPANY]2
HYPROMELLOSESACTIVE INGREDIENT3NXW29V3WOARTIFICIAL TEARS (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400) LIQUID [AMERICAN SALES COMPANY]2
POLYETHYLENE GLYCOL 400ACTIVE INGREDIENTB697894SGQARTIFICIAL TEARS (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400) LIQUID [AMERICAN SALES COMPANY]2
GLYCERINACTIVE MOIETYPDC6A3C0OXARTIFICIAL TEARS (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400) LIQUID [AMERICAN SALES COMPANY]2
HYPROMELLOSESACTIVE MOIETY3NXW29V3WOARTIFICIAL TEARS (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400) LIQUID [AMERICAN SALES COMPANY]2
POLYETHYLENE GLYCOL 400ACTIVE MOIETYB697894SGQARTIFICIAL TEARS (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400) LIQUID [AMERICAN SALES COMPANY]2
ASCORBIC ACIDINACTIVE INGREDIENTPQ6CK8PD0RARTIFICIAL TEARS (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400) LIQUID [AMERICAN SALES COMPANY]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7ARTIFICIAL TEARS (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400) LIQUID [AMERICAN SALES COMPANY]2
BORIC ACIDINACTIVE INGREDIENTR57ZHV85D4ARTIFICIAL TEARS (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400) LIQUID [AMERICAN SALES COMPANY]2
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2ARTIFICIAL TEARS (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400) LIQUID [AMERICAN SALES COMPANY]2
GLYCINEINACTIVE INGREDIENTTE7660XO1CARTIFICIAL TEARS (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400) LIQUID [AMERICAN SALES COMPANY]2
MAGNESIUM CHLORIDEINACTIVE INGREDIENT02F3473H9OARTIFICIAL TEARS (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400) LIQUID [AMERICAN SALES COMPANY]2
POTASSIUM CHLORIDEINACTIVE INGREDIENT660YQ98I10ARTIFICIAL TEARS (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400) LIQUID [AMERICAN SALES COMPANY]2
SODIUM BORATEINACTIVE INGREDIENT91MBZ8H3QOARTIFICIAL TEARS (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400) LIQUID [AMERICAN SALES COMPANY]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XARTIFICIAL TEARS (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400) LIQUID [AMERICAN SALES COMPANY]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRARTIFICIAL TEARS (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400) LIQUID [AMERICAN SALES COMPANY]2
SODIUM LACTATEINACTIVE INGREDIENTTU7HW0W0QTARTIFICIAL TEARS (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400) LIQUID [AMERICAN SALES COMPANY]2
WATERINACTIVE INGREDIENT059QF0KO0RARTIFICIAL TEARS (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400) LIQUID [AMERICAN SALES COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-865ARTIFICIAL TEARS (GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400) LIQUID [AMERICAN SALES COMPANY]4Legacy NDC, 2 package rows20191029_4c62432b-bd6d-46ac-a5fb-8dadfda04846.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259581glycerin 0.2 % / hypromellose 0.2 % / polyethylene glycol 400 1 % Ophthalmic SolutionPSN4c62432b-bd6d-46ac-a5fb-8dadfda048464
259581glycerin 2 MG/ML / hypromellose 2 MG/ML / polyethylene glycol 400 10 MG/ML Ophthalmic SolutionSCD4c62432b-bd6d-46ac-a5fb-8dadfda048464
259581glycerin 0.2 % / hypromellose 0.2 % / PEG 400 1 % Ophthalmic SolutionSY4c62432b-bd6d-46ac-a5fb-8dadfda048464

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41520-865-05415200865051 BOTTLE in 1 BOX (41520-865-05) > 15 mL in 1 BOTTLE1 bottle2010-09-100000-00-00NoNoCurrent