Allergy Relief Eye Drops

Product NDC
51316-633
11-digit product format
513160633
Labeler code
51316
Product ID
51316-633_88b43dee-d784-1e6b-63eb-34db0ac59530
Type
HUMAN OTC DRUG
Nonproprietary name
olopatadine hydrochloride ophthalmic
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
CVS Pharmacy
Application
ANDA213514
Marketing category
ANDA
Marketing start
2026-01-15
Substance
OLOPATADINE HYDROCHLORIDE
Active strength
7 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
Allergy Relief Eye Drops
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLOPATADINE HYDROCHLORIDE7 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2XG66W44KF
Rxcui1601086

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-633-01Allergy Relief Eye Drops2.5 mL in 1 BOTTLESOLUTION2.51
51316-633-02Allergy Relief Eye Drops2 in 1 CARTONSOLUTION21

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1601086olopatadine HCl 0.7 % Ophthalmic SolutionPSNdad4b9f2-f4f8-fe9a-ae9d-35511864dad01
1601086olopatadine 7 MG/ML Ophthalmic SolutionSCDdad4b9f2-f4f8-fe9a-ae9d-35511864dad01
1601086olopatadine 0.7 % Ophthalmic SolutionSYdad4b9f2-f4f8-fe9a-ae9d-35511864dad01
1601086olopatadine 7 MG/ML (as olopatadine HCl 7.76 MG/ML) Ophthalmic SolutionSYdad4b9f2-f4f8-fe9a-ae9d-35511864dad01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-633-01513160633012.5 mL in 1 BOTTLE2.5 mlHistorical
51316-633-02513160633022 BOTTLE in 1 CARTON (51316-633-02) / 2.5 mL in 1 BOTTLE (51316-633-01) 2 bottle2026-01-15NoNoHistorical