Eye Allergy Itch Relief

Product NDC
0363-1325
11-digit product format
003631325
Labeler code
0363
Product ID
0363-1325_728c16c0-cc2b-10c0-6ee8-cedb095a0c4b
Type
HUMAN OTC DRUG
Nonproprietary name
olopatadine hydrochloride ophthalmic
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Walgreen Company
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
Eye Allergy Itch Relief
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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1601086olopatadine HCl 0.7 % Ophthalmic SolutionPSN56a99d87-b88b-d140-2dc7-08af5a9f45fb1
1601086olopatadine 7 MG/ML Ophthalmic SolutionSCD56a99d87-b88b-d140-2dc7-08af5a9f45fb1
1601086olopatadine 0.7 % Ophthalmic SolutionSY56a99d87-b88b-d140-2dc7-08af5a9f45fb1
1601086olopatadine 7 MG/ML (as olopatadine HCl 7.76 MG/ML) Ophthalmic SolutionSY56a99d87-b88b-d140-2dc7-08af5a9f45fb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-1325-01003631325011 BOTTLE in 1 CARTON (0363-1325-01) / 2.5 mL in 1 BOTTLE1 bottle2026-01-15NoNoHistorical
0363-1325-02003631325022 BOTTLE in 1 CARTON (0363-1325-02) / 2.5 mL in 1 BOTTLE2 bottle2026-01-15NoNoHistorical