good neighbor pharmacy all day allergy d

Product NDC: 46122-626
11-digit product format: 461220626
Labeler code: 46122
Product ID: 46122-626_5030343f-d4db-45fa-aa8a-ef474a5a2fa0
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine hydrochloride, Pseudoephedrine hydrochloride
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Amerisource Bergen
Application: ANDA210719
Marketing category: ANDA
Marketing start: 2020-03-30
Substance: CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength: 5; 120 mg/1; mg/1
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: good neighbor pharmacy all day allergy d
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CETIRIZINE HYDROCHLORIDE	5 mg/1
PSEUDOEPHEDRINE HYDROCHLORIDE	120 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
64O047KTOA	Internal UNII lookup
6V9V2RYJ8N	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1014571	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a7c7b475-ca3c-4e3c-bc6b-a0e1362ded3b	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
46122-626-62	good neighbor pharmacy all day allergy d	1 in 1 BLISTER PACK	TABLET, FILM COATED, EXTENDED RE	1		3
46122-626-62	good neighbor pharmacy all day allergy d	24 in 1 CARTON	TABLET, FILM COATED, EXTENDED RE	24		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
46122-626-62	EA - Each	46122-626	0dcd3748-8e05-45b2-a029-d362f93ba07f	1	2020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46122-626	GOOD NEIGHBOR PHARMACY ALL DAY ALLERGY D (CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [AMERISOURCE BERGEN]	3	Current NDC, Legacy NDC, 2 package rows	20250108_a7c7b475-ca3c-4e3c-bc6b-a0e1362ded3b.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 ndc (product): 46122-626
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	a7c7b475-ca3c-4e3c-bc6b-a0e1362ded3b	3
1014571	12 HR cetirizine hydrochloride 5 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet	SCD	a7c7b475-ca3c-4e3c-bc6b-a0e1362ded3b	3
1014571	cetirizine dihydrochloride 5 MG / pseudoephedrine HCl 120 MG 12 HR Extended Release Oral Tablet	SY	a7c7b475-ca3c-4e3c-bc6b-a0e1362ded3b	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
46122-626-62	46122062662	24 BLISTER PACK in 1 CARTON (46122-626-62) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK	24 blister pack	2020-03-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Amerisource Bergen All Day Allergy-D Drug Facts	Amerisource Bergen	2025-01-03	HUMAN OTC DRUG LABEL	3