Wal-Zyr

Product NDC: 0363-2106
11-digit product format: 003632106
Labeler code: 0363
Product ID: 0363-2106_236ed4fb-cea6-468a-9a9c-10e346533690
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: WALGREEN COMPANY
Application: ANDA201546
Marketing category: ANDA
Marketing start: 2011-05-20
Substance: CETIRIZINE HYDROCHLORIDE
Active strength: 5 mg/5mL
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
CETIRIZINE HYDROCHLORIDE	5 mg/5mL

Field, Values table
Field	Values
Unii	64O047KTOA
Rxcui	1014673, 1482533

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a21a21e5-f36d-4c1f-8918-def921b8f7e3	Product name	3	20250124
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35be	Product name	1	20200304
a255659f-db40-429d-8c07-5f173f330d9c	Product name	1	20190402
48747306-602a-42cc-957b-5b0c69158eee	Product name	1	20180604
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b	Product name	1	20140508

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0363-2106-01	Wal-Zyr All Day Allergy	240 mL in 1 BOTTLE	SOLUTION	240	5
0363-2106-01	Wal-Zyr All Day Allergy	1 in 1 CARTON	SOLUTION	1	5
0363-2106-08	Wal-Zyr All Day Allergy	120 mL in 1 BOTTLE	SOLUTION	120	5
0363-2106-08	Wal-Zyr All Day Allergy	1 in 1 CARTON	SOLUTION	1	5

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-2106	WAL-ZYR ALL DAY ALLERGY (CETIRIZINE HYDROCHLORIDE) SOLUTION [WALGREEN COMPANY]	5	Current NDC, Legacy NDC, 4 package rows	20190208_4ce79791-748a-49d0-af34-73f589670d3f.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
64O047KTOA	CETIRIZINE HYDROCHLORIDE	83881-52-1	CETIRIZINE HYDROCHLORIDE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1014673	cetirizine HCl 5 MG in 5 mL Oral Solution	PSN	4ce79791-748a-49d0-af34-73f589670d3f	5
1482533	Wal-Zyr Children's 5 MG in 5 mL Oral Solution	PSN	4ce79791-748a-49d0-af34-73f589670d3f	5
1482533	cetirizine hydrochloride 1 MG/ML Oral Solution [Wal Zyr 24 Hour Allergy]	SBD	4ce79791-748a-49d0-af34-73f589670d3f	5
1014673	cetirizine hydrochloride 1 MG/ML Oral Solution	SCD	4ce79791-748a-49d0-af34-73f589670d3f	5
1014673	cetirizine HCl 1 MG/ML Oral Syrup	SY	4ce79791-748a-49d0-af34-73f589670d3f	5
1014673	cetirizine HCl 5 MG per 5 ML Oral Solution	SY	4ce79791-748a-49d0-af34-73f589670d3f	5
1482533	Wal Zyr 24 Hour Allergy 1 MG/ML Oral Solution	SY	4ce79791-748a-49d0-af34-73f589670d3f	5
1482533	Wal-Zyr 1 MG/ML Oral Solution	SY	4ce79791-748a-49d0-af34-73f589670d3f	5
1482533	Wal-Zyr 5 MG per 5 ML Oral Solution	SY	4ce79791-748a-49d0-af34-73f589670d3f	5

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0363-2106-01	00363210601	1 BOTTLE in 1 CARTON (0363-2106-01) / 240 mL in 1 BOTTLE	1 bottle	2011-05-20	0000-00-00	No	No	Current
0363-2106-08	00363210608	1 BOTTLE in 1 CARTON (0363-2106-08) / 120 mL in 1 BOTTLE	1 bottle	2011-05-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Wal-Zyr™ Children's Wal-Zyr	WALGREEN COMPANY \| Taro Pharmaceuticals U.S.A., Inc. \| Taro Pharmaceutical Industries, Ltd.	2019-02-07	HUMAN OTC DRUG LABEL	5