FDA.reportPublic FDA data

CVS Eye Allergy Itch Relief

Product NDC
69842-269
11-digit product format
698420269
Labeler code
69842
Product ID
69842-269_d334f71b-7150-b01e-bc10-4d7e45d368c0
Type
HUMAN OTC DRUG
Nonproprietary name
Olopatadine Hydrochloride Ophthalmic
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
CVS Health Corp
Application
ANDA209752
Marketing category
ANDA
Marketing start
2020-09-20
Substance
OLOPATADINE HYDROCHLORIDE
Active strength
2 mg/mL
Pharmacologic classes
Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Histamine-1 Receptor Inhibitor [EPC], Mast Cell Stabilizer [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CVS Eye Allergy Itch Relief
Brand name suffix
Once Daily
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLOPATADINE HYDROCHLORIDE2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2XG66W44KF
Rxcui1111343

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
624001e0-0eba-4aac-a60c-c2ecb37d4f08Product name120220927
abab02bf-82c6-4b6c-8cb4-2ee39055aeb1Product name320210312
ee1438f7-d464-b7de-1b3a-aae378f7d672Product name820200121
4101b788-a943-3f81-6947-4acf7be2af4dProduct name420190703
ca2d4a1a-2b5b-4256-9aad-735e9282b3eeProduct name120150323
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69842-269-25ML - Milliliter69842-26945c10703-e213-4aa5-9efe-c97ccfbfaedd12021-08-05
69842-269-50ML - Milliliter69842-269c88e9d23-d697-451c-8dd6-b54db65e089412021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-269CVS EYE ALLERGY ITCH RELIEF ONCE DAILY (OLOPATADINE HYDROCHLORIDE OPHTHALMIC) SOLUTION [CVS HEALTH CORP]3Current NDC, Legacy NDC20231019_fd0e681a-f217-1a97-e9a7-d740816234ff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1111343olopatadine HCl 0.2 % Ophthalmic SolutionPSNfd0e681a-f217-1a97-e9a7-d740816234ff4
1111343olopatadine 2 MG/ML Ophthalmic SolutionSCDfd0e681a-f217-1a97-e9a7-d740816234ff4
1111343olopatadine 0.2 % Ophthalmic SolutionSYfd0e681a-f217-1a97-e9a7-d740816234ff4
1111343olopatadine 2 MG/ML (as olopatadine HCl 2.22 MG/ML) Ophthalmic SolutionSYfd0e681a-f217-1a97-e9a7-d740816234ff4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69842-269-25698420269251 BOTTLE, PLASTIC in 1 CARTON (69842-269-25) / 2.5 mL in 1 BOTTLE, PLASTIC2020-09-200000-00-00NoNoCurrent
69842-269-50698420269502 BOTTLE, PLASTIC in 1 CARTON (69842-269-50) / 2.5 mL in 1 BOTTLE, PLASTIC2020-09-200000-00-00NoNoCurrent