FDA.reportPublic FDA data

artificial tears

Product NDC
11822-0011
11-digit product format
118220011
Labeler code
11822
Product ID
11822-0011_6d14ded0-27cb-49e4-b8d1-3860d1211675
Type
HUMAN OTC DRUG
Nonproprietary name
lubricant eye drops
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
RITE AID CORPORATION
Application
part349
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2017-01-01
Marketing end
0000-00-00
Substance
GLYCERIN; PROPYLENE GLYCOL
Active strength
3 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct11822-0011DDiscontinued by firm2026-10-05
excluded packagepackage11822-001111822-0011-3DDiscontinued by firm2026-10-05
excluded packagepackage11822-001111822-0011-5DDiscontinued by firm2026-10-05

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
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
11822-0011-3artificial tears30 mL in 1 BOTTLESOLUTION/ DROPS304
11822-0011-3artificial tears1 in 1 CARTONSOLUTION/ DROPS14
11822-0011-5artificial tears1 in 1 CARTONSOLUTION/ DROPS14
11822-0011-5artificial tears15 mL in 1 BOTTLESOLUTION/ DROPS154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0011ARTIFICIAL TEARS (LUBRICANT EYE DROPS) SOLUTION/ DROPS [RITE AID CORPORATION]4Legacy NDC, 4 package rows20240720_fd799b50-68ac-4d9a-8975-d0bfa465a4c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259195glycerin 0.3 % / propylene glycol 1 % Ophthalmic SolutionPSNfd799b50-68ac-4d9a-8975-d0bfa465a4c34
259195glycerin 3 MG/ML / propylene glycol 10 MG/ML Ophthalmic SolutionSCDfd799b50-68ac-4d9a-8975-d0bfa465a4c34
259195glycerin 0.3 % / propylene glycol 1 % Ophthalmic SolutionSYfd799b50-68ac-4d9a-8975-d0bfa465a4c34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0011-3118220011031 BOTTLE in 1 CARTON (11822-0011-3) > 30 mL in 1 BOTTLE1 bottle2017-01-010000-00-00NoNoCurrent
11822-0011-5118220011051 BOTTLE in 1 CARTON (11822-0011-5) > 15 mL in 1 BOTTLE1 bottle2017-01-010000-00-00NoNoCurrent