WAL ZYR D

Product NDC: 0363-1147
11-digit product format: 003631147
Labeler code: 0363
Product ID: 0363-1147_c73e13a0-6791-48ac-b158-4b5e72c7a837
Type: HUMAN OTC DRUG
Nonproprietary name: cetirizine hydrochloride, pseudoephedrine hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Walgreen Company
Application: ANDA210719
Marketing category: ANDA
Marketing start: 2020-03-26
Marketing end: 0000-00-00
Substance: CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength: 5 mg/1; mg/1
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0363-1147		I	Inactivated by FDA	2026-08-03
excluded package	package	0363-1147	0363-1147-53	D	Discontinued by firm	2026-08-03
excluded package	package	0363-1147	0363-1147-62	D	Discontinued by firm	2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 33 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0363-1147-53	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0363-1147-62	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0363-1147-53	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0363-1147-62	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0363-1147-53	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0363-1147-62	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0363-1147-53	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0363-1147-62	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0363-1147-53	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0363-1147-62	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0363-1147-53	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0363-1147-62	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0363-1147-53	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0363-1147-62	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0363-1147-53	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0363-1147-62	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0363-1147-53	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0363-1147-62	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0363-1147-53	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0363-1147-62	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0363-1147-53	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0363-1147-62	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0363-1147-53	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0363-1147-62	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210719-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL			2018-11-16

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210719-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210719-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210719-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210719-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210719-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210719-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210719-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210719-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210719-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210719-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210719-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210719-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210719-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210719-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210719-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210719-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210719-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210719-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210719-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210719-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210719-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210719-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210719-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210719-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210719-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210719-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210719-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210719-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210719-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210719-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210719-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210719-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210719-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210719-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210719-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210719-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210719-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210719-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210719-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210719-001	CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	TABLET, EXTENDED RELEASE / ORAL	2018-11-16	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35be	Product name	1	20200304
a255659f-db40-429d-8c07-5f173f330d9c	Product name	1	20190402
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66	Product name	1	20140508
70a83adc-6047-bbea-5a08-dfd304aa47d2	Product name	1	20140508
858ce051-9941-aafc-8c7c-44a8e0227463	Product name	1	20140508
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0363-1147-53	2025-01-30	C162847	48780-1	2cef2736-8fba-d83d-e063-dadaa90ab31f	Walgreen Co. Wal-Zyr ™ D Drug Facts
0363-1147-62	2025-01-30	C162847	48780-1	2cef2736-8fba-d83d-e063-dadaa90ab31f	Walgreen Co. Wal-Zyr ™ D Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0363-1147-53	WAL ZYR D	1 in 1 BLISTER PACK	TABLET, FILM COATED, EXTENDED RE	1	3
0363-1147-53	WAL ZYR D	12 in 1 CARTON	TABLET, FILM COATED, EXTENDED RE	12	3
0363-1147-62	WAL ZYR D	1 in 1 BLISTER PACK	TABLET, FILM COATED, EXTENDED RE	1	3
0363-1147-62	WAL ZYR D	24 in 1 CARTON	TABLET, FILM COATED, EXTENDED RE	24	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-1147	WAL ZYR D (CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [WALGREEN COMPANY]	3	Legacy NDC, 4 package rows	20231121_f1448ef3-64fd-491f-a79d-cb974fc669c6.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 20 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
allergy relief-D	CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE	Rite Aid Corporation	fdf98201-661c-4b1e-97f6-265807d90f76	2026-05-27	Warnings	Exact identifier application applno (ANDA): 210719 application number: ANDA210719
allergy relief D12	CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE	Walgreen Company	aa515879-9851-4915-bd41-51d81e585dd7	2026-02-28	Warnings	Exact identifier application applno (ANDA): 210719 application number: ANDA210719
ALLERGY RELIEF D12	CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	5b6cd5ba-bdca-434e-b024-0089aeeec6a1	2026-02-17	Warnings	Exact identifier application applno (ANDA): 210719 application number: ANDA210719
Allergy and Sinus Relief	CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE	Kroger Company	28d3aee3-52fb-4e87-a6f2-4634f1770a70	2026-01-19	Warnings	Exact identifier application applno (ANDA): 210719 application number: ANDA210719
FOSTER AND THRIVE ALL DAY ALLERGY D	CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE	Strategic Sourcing Services LLC	796bea75-847a-40cd-892c-0905caae5c4e	2025-12-10	Warnings	Exact identifier application applno (ANDA): 210719 application number: ANDA210719
All Day Allergy D	CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE	L. Perrigo Company	b38cb1c8-3575-4283-8692-00cd4cd8d5cc	2025-10-02	Warnings	Exact identifier application applno (ANDA): 210719 application number: ANDA210719
12 hour allergy d	CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE	Meijer Distribution Inc	b7019ea1-ca3d-4ddb-8cf4-e4ca7cb95e77	2025-06-19	Warnings	Exact identifier application applno (ANDA): 210719 application number: ANDA210719
allergy relief d	CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE	Publix Super Markets Inc	821c3880-303d-470a-af6a-e13be7ab313f	2025-02-12	Warnings	Exact identifier application applno (ANDA): 210719 application number: ANDA210719
Cetirizine hydrochloride and Pseudoephedrine hydrochloride	CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE	Padagis Israel Pharmaceuticals Ltd	3260111b-35da-4f95-8081-51eae4b1ef45	2025-02-12	Warnings	Exact identifier application applno (ANDA): 210719 application number: ANDA210719
topcare all day allergy d	CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE	Topco Associates LLC	103df878-1455-414f-94cb-5b32a2d3e4b8	2025-02-12	Warnings	Exact identifier application applno (ANDA): 210719 application number: ANDA210719
equate allergy relief d nasal decongestant	CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE	WALMART INC.	7b7b8cce-ede6-47c6-91c8-88fd94cb292d	2025-02-12	Warnings	Exact identifier application applno (ANDA): 210719 application number: ANDA210719
all day allergy d	CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE	Kroger Company	2f1df816-311b-444a-8040-21227016614b	2025-02-12	Warnings	Exact identifier application applno (ANDA): 210719 application number: ANDA210719
allergy relief d	CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE	CVS Pharmacy	fe26cba3-5b84-462c-ac2b-e9e09612ad1d	2025-02-12	Warnings	Exact identifier application applno (ANDA): 210719 application number: ANDA210719
Rugby Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride	CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE	Rugby Laboratories	5c6ac9a2-4f0a-4297-9b83-988d54598f75	2025-02-12	Warnings	Exact identifier application applno (ANDA): 210719 application number: ANDA210719
signature care allergy relief d	CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE	Safeway	8f2bcfe7-aac3-4a57-8ebb-c6f8a5829c80	2025-02-12	Warnings	Exact identifier application applno (ANDA): 210719 application number: ANDA210719
allergy relief d	CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE	H E B	b3ca8aae-04f2-4c00-9fb5-ce3ed7e6f1bb	2025-02-11	Warnings	Exact identifier application applno (ANDA): 210719 application number: ANDA210719
kirkland signature aller tec d	CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE	Costco Wholesale Company	a8e57b21-4622-4315-8e8e-437243be2fe1	2025-02-04	Warnings	Exact identifier application applno (ANDA): 210719 application number: ANDA210719
good sense all day allergy d	CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE	L. Perrigo Company	c7154370-5d91-4dc4-90ed-1d07d9bc5943	2025-02-04	Warnings	Exact identifier application applno (ANDA): 210719 application number: ANDA210719
good neighbor pharmacy all day allergy d	CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE	Amerisource Bergen	a7c7b475-ca3c-4e3c-bc6b-a0e1362ded3b	2025-01-03	Warnings	Exact identifier application applno (ANDA): 210719 application number: ANDA210719
Leader Allergy Relief D	CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE	Cardinal Health 110, LLC. dba Leader	3152060c-f613-49db-91d4-356d2070c466	2023-06-15	Warnings	Exact identifier application applno (ANDA): 210719 application number: ANDA210719

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
64O047KTOA	CETIRIZINE HYDROCHLORIDE	83881-52-1	CETIRIZINE HYDROCHLORIDE
6V9V2RYJ8N	PSEUDOEPHEDRINE HYDROCHLORIDE	345-78-8	PSEUDOEPHEDRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1014571	cetirizine HCl 5 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral Tablet	PSN	f1448ef3-64fd-491f-a79d-cb974fc669c6	3
1014580	WAL-ZYR D ALLERGY & CONGESTION 5 MG / 120 MG 12HR Extended Release Oral Tablet	PSN	f1448ef3-64fd-491f-a79d-cb974fc669c6	3
1014580	12 HR cetirizine hydrochloride 5 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet [Wal Zyr D]	SBD	f1448ef3-64fd-491f-a79d-cb974fc669c6	3
1014571	12 HR cetirizine hydrochloride 5 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet	SCD	f1448ef3-64fd-491f-a79d-cb974fc669c6	3
1014571	cetirizine dihydrochloride 5 MG / pseudoephedrine HCl 120 MG 12 HR Extended Release Oral Tablet	SY	f1448ef3-64fd-491f-a79d-cb974fc669c6	3
1014580	Wal Zyr D (cetirizine dihydrochloride 5 MG / pseudoephedrine hydrochloride 120 MG) 12 HR Extended Release Oral Tablet	SY	f1448ef3-64fd-491f-a79d-cb974fc669c6	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0363-1147-53	00363114753	12 BLISTER PACK in 1 CARTON (0363-1147-53) > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK	12 blister pack	2020-03-26	0000-00-00	No	No	Current
0363-1147-62	00363114762	24 BLISTER PACK in 1 CARTON (0363-1147-62) > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK	24 blister pack	2020-03-26	0000-00-00	No	No	Current