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NDC 00065-0816-01 PATADAY ONCE DAILY RELIEF 7 mg/mL Details

PATADAY ONCE DAILY RELIEF 7 mg/mL

PATADAY ONCE DAILY RELIEF is a OPHTHALMIC SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Alcon Laboratories, Inc.. The primary component is OLOPATADINE HYDROCHLORIDE.

MedlinePlus Drug Summary

Prescription ophthalmic olopatadine (Pazeo) and nonprescription ophthalmic olopatadine (Pataday) are used to relieve itchy eyes caused by allergic reactions to pollen, ragweed, grass, animal hair, or pet dander. Olopatadine is in a class of medications called mast cell stabilizers. It works by preventing the release of substances that cause eye itching.

Related Packages: 00065-0816-01
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Olopatadine Ophthalmic

Product Information

NDC	00065-0816
Product ID	0065-0816_c6eef41b-de2a-4461-9880-bc220176e886
Associated GPIs	86802065102040
GCN Sequence Number	073483
GCN Sequence Number Description	olopatadine HCl DROPS 0.7 % OPHTHALMIC
HIC3	Q6R
HIC3 Description	EYE ANTIHISTAMINES
GCN	37855
HICL Sequence Number	012815
HICL Sequence Number Description	OLOPATADINE HCL
Brand/Generic	Brand
Proprietary Name	PATADAY ONCE DAILY RELIEF
Proprietary Name Suffix	n/a
Non-Proprietary Name	OLOPATADINE HYDROCHLORIDE
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	OPHTHALMIC
Active Ingredient Strength	7
Active Ingredient Units	mg/mL
Substance Name	OLOPATADINE HYDROCHLORIDE
Labeler Name	Alcon Laboratories, Inc.
Pharmaceutical Class	Decreased Histamine Release [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Histamine-1 Receptor Inhibitor [EPC], Mast Cell Stabilizer [EPC]
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA206276
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00065-0816-01 (00065081601)

Pricing Information	N/A
NDC Package Code	0065-0816-01
Billing NDC	00065081601
Package	2 BOTTLE, PLASTIC in 1 CARTON (0065-0816-01) / 2.5 mL in 1 BOTTLE, PLASTIC
Marketing Start Date	2021-01-04
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 6d07a5d6-265c-4735-97b3-8a2575b276cb Details

SPL UNCLASSIFIED SECTION

Active Ingredients	Purpose
Olopatadine (0.7%) (equivalent to olopatadine hydrochloride 0.776%)	Antihistamine

SPL UNCLASSIFIED SECTION

Use temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander

SPL UNCLASSIFIED SECTION

Warnings

For external use only

Do not use

if solution changes color or becomes cloudy
if you are sensitive to any ingredient in this product
to treat contact lens related irritation

When using this product

do not touch tip of container to any surface to avoid contamination
remove contact lenses before use
wait at least 10 minutes before reinserting contact lenses after use
do not wear a contact lens if your eye is red

SPL UNCLASSIFIED SECTION

Stop use and ask a doctor if you experience:

eye pain
changes in vision
increased redness of the eye
itching worsens or lasts for more than 72 hours

SPL UNCLASSIFIED SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 2 years of age and older:
- put 1 drop in the affected eye(s) once daily
- do not use more than 1 drop in each eye per day
- if using other ophthalmic products while using this product, wait at least 5 minutes between each product
- replace cap after each use
children under 2 years of age: consult a doctor

Other information

only for use in the eye
store between 2°-25°C (36°-77°F)

Inactive ingredients

benzalkonium chloride 0.015%, boric acid, hydrochloric acid/sodium hydroxide (to adjust pH), hydroxypropylgamma- cyclodextrin, hypromellose, mannitol, polyethylene glycol 400, povidone, and purified water

Questions?

In the U.S., call 1-800-757-9195 or email [email protected]

PRINCIPAL DISPLAY PANEL

EXTRA STRENGTH

Pataday®

ONCE DAILY RELIEF

Olopatadine hydrochloride

ophthalmic solution 0.7%

Antihistamine

Eye Allergy Itch Relief

FULL 24 HOUR

Works in Minutes

Relief from Allergens:

   • Pet Dander

   • Pollen

• Grass

   • Ragweed

Alcon

STERILE

2.5 mL (0.085 FL OZ)

EXTRA STRENGTH

Pataday®

ONCE DAILY RELIEF

TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with Alcon around the neck. Do not use if seal is damaged or missing at time of purchase.

30 DAY SUPPLY

Eye Allergy Itch Relief

Works in Minutes

For Ages 2 and Older

________Fill Line________

Alcon Laboratories, Inc.

6201 South Freeway

Fort Worth, Texas 76134

Country of Origin: Japan

ACTUAL SIZE

NDC: 0065-0816-04

300038456-0620

LOT:                         EXP.:

3187

EXTRA STRENGTH

Pataday®

ONCE DAILY RELIEF

Olopatadine hydrochloride

ophthalmic solution 0.7% Antihistamine

2.5 mL (0.085 FL OZ)

STERILE

Only for use in the eye.

Store between 2°– 25° C (36°– 77° F)

TAMPER EVIDENT: For your protection, this bottle has a seal imprinted with Alcon around the neck. Do not use if seal is damaged or missing at time of purchase.

Alcon Laboratories, Inc.

6201 South Freeway

Fort Worth, TX 76134

LOT: EXP.:

300038442-0620

INGREDIENTS AND APPEARANCE

PATADAY ONCE DAILY RELIEF

olopatadine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0065-0816
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Olopatadine Hydrochloride (UNII: 2XG66W44KF) (Olopatadine - UNII:D27V6190PM)	Olopatadine	7 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Benzalkonium Chloride (UNII: F5UM2KM3W7)
Boric Acid (UNII: R57ZHV85D4)
Hydrochloric Acid (UNII: QTT17582CB)
Sodium Hydroxide (UNII: 55X04QC32I)
Hydroxypropyl .Gamma.-Cyclodextrin (UNII: P6BYU725IU)
Hypromellose, Unspecified (UNII: 3NXW29V3WO)
Mannitol (UNII: 3OWL53L36A)
Polyethylene Glycol 400 (UNII: B697894SGQ)
Povidone, Unspecified (UNII: FZ989GH94E)
Water (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0065-0816-04	1 in 1 CARTON	09/01/2020
1		2.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:0065-0816-01	2 in 1 CARTON	01/04/2021
2		2.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3	NDC:0065-0816-02	1 in 1 CARTON	01/04/2021
3		0.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4	NDC:0065-0816-12	3 in 1 CARTON	01/24/2022
4		2.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA206276	09/01/2020

Labeler - Alcon Laboratories, Inc. (008018525)

Name	Address	ID/FEI	Business Operations
Establishment
Alcon Research LLC		007672236	manufacture(0065-0816)

Revised: 6/2022

Document Id: c6eef41b-de2a-4461-9880-bc220176e886

Set id: 6d07a5d6-265c-4735-97b3-8a2575b276cb

Version: 4

Effective Time: 20220621

Search by Drug Name or NDC

NDC 00065-0816-01 PATADAY ONCE DAILY RELIEF 7 mg/mL Details

PATADAY ONCE DAILY RELIEF 7 mg/mL

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 00065-0816-01 (00065081601)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 6d07a5d6-265c-4735-97b3-8a2575b276cb Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Do not use

When using this product

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Directions

Other information

Inactive ingredients

Questions?

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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