All Day Allergy

Product NDC: 41520-212
11-digit product format: 415200212
Labeler code: 41520
Product ID: 41520-212_67a5a75a-7a28-4d07-99b4-8325d1776f3a
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine HCl
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Care One (American Sales Company)
Application: ANDA205291
Marketing category: ANDA
Marketing start: 2024-12-31
Substance: CETIRIZINE HYDROCHLORIDE
Active strength: 10 mg/1
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	CAPSULE / ORAL			2017-07-21

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205291-001	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	2017-07-21	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: All Day Allergy
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
CETIRIZINE HYDROCHLORIDE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1014675	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
01d0729f-11ef-4ec5-8d8e-2863407c3f95	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35be	Product name	1	20200304
a255659f-db40-429d-8c07-5f173f330d9c	Product name	1	20190402
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
41520-212-25	All Day Allergy	1 in 1 BOX	CAPSULE, LIQUID FILLED	1		2
41520-212-25	All Day Allergy	25 in 1 BOTTLE, PLASTIC	CAPSULE, LIQUID FILLED	25		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41520-212	ALL DAY ALLERGY (CETIRIZINE HCL) CAPSULE, LIQUID FILLED [CARE ONE (AMERICAN SALES COMPANY)]	2	Current NDC, 2 package rows	20250409_01d0729f-11ef-4ec5-8d8e-2863407c3f95.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
cetirizine hydrochloride	CETIRIZINE HYDROCHLORIDE	Strides Pharma, Inc.	29c433eb-6cf4-4bcf-8b2a-0398fb4cdcba	2026-08-24	Warnings	Exact identifier application applno (ANDA): 205291 application number: ANDA205291
Allergy Relief	CETIRIZINE HCL	CVS PHARMACY, INC	a57a0dbe-0926-4b25-a5d7-b8d499d67158	2026-05-11	Warnings	Exact identifier application applno (ANDA): 205291 application number: ANDA205291
Allergy Relief	CETIRIZINE HCL	WALMART INC. (see also Equate)	41bc1339-7137-4472-b47b-a7a36e24a9bb	2025-04-29	Warnings	Exact identifier application applno (ANDA): 205291 application number: ANDA205291
All Day Allergy	CETIRIZINE HCL	Care One (American Sales Company)	01d0729f-11ef-4ec5-8d8e-2863407c3f95	2025-04-07	Warnings	Exact identifier application applno (ANDA): 205291 application number: ANDA205291 ndc (product): 41520-212

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1014675	cetirizine HCl 10 MG 24HR Oral Capsule	PSN	01d0729f-11ef-4ec5-8d8e-2863407c3f95	2
1014675	cetirizine hydrochloride 10 MG Oral Capsule	SCD	01d0729f-11ef-4ec5-8d8e-2863407c3f95	2
1014675	cetirizine HCl 10 MG 24 HR Oral Capsule	SY	01d0729f-11ef-4ec5-8d8e-2863407c3f95	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
41520-212-25	41520021225	1 BOTTLE, PLASTIC in 1 BOX (41520-212-25) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC	2024-12-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Cetirizine Hydrochloride Tablets	Care One (American Sales Company)	2025-04-07	HUMAN OTC DRUG LABEL	2