All Day Allergy

Product NDC: 36800-211
Requested package NDC: 36800-211-25
11-digit product format: 368000211
Labeler code: 36800
Product ID: 36800-211_1506580b-b2fa-4193-aa97-3627b9e26587
Type: HUMAN OTC DRUG
Nonproprietary name: Cetirizine HCl
Dosage form: CAPSULE
Route: ORAL
Labeler: TOP CARE (Topco Associates LLC)
Application: NDA022429
Marketing category: NDA
Marketing start: 2013-04-30
Marketing end: 2021-12-31
Substance: CETIRIZINE HYDROCHLORIDE
Active strength: 10 mg/1
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	36800-211	36800-211-25	D	Discontinued by firm		2026-08-10

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N022429-001	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	RLD	2009-07-23
N022429-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23
N022429-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	5MG	CAPSULE / ORAL	RLD	2009-07-23
N022429-004	CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23

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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022429-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	CAPSULE / ORAL	RLD	2009-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022429-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022429-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	CAPSULE / ORAL	RLD	2009-07-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022429-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022429-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	CAPSULE / ORAL	RLD	2009-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022429-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022429-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	CAPSULE / ORAL	RLD	2009-07-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022429-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022429-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	CAPSULE / ORAL	RLD	2009-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022429-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022429-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	CAPSULE / ORAL	RLD	2009-07-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022429-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022429-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	CAPSULE / ORAL	RLD	2009-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022429-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022429-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	CAPSULE / ORAL	RLD	2009-07-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022429-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022429-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	CAPSULE / ORAL	RLD	2009-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022429-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022429-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	CAPSULE / ORAL	RLD	2009-07-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022429-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022429-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	CAPSULE / ORAL	RLD	2009-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022429-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022429-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	CAPSULE / ORAL	RLD	2009-07-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022429-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022429-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	CAPSULE / ORAL	RLD	2009-07-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022429-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022429-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	CAPSULE / ORAL	RLD	2009-07-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022429-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022429-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	CAPSULE / ORAL	RLD	2009-07-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022429-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022429-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	CAPSULE / ORAL	RLD	2009-07-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022429-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022429-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	CAPSULE / ORAL	RLD	2009-07-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022429-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022429-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	CAPSULE / ORAL	RLD	2009-07-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022429-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022429-001	CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	CAPSULE / ORAL	RLD	2009-07-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022429-002	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022429-003	CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	CAPSULE / ORAL	RLD	2009-07-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022429-004	CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	CAPSULE / ORAL	RLD, RS	2009-07-23	`d06236e962d9…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CETIRIZINE HYDROCHLORIDE	ACTIVE INGREDIENT	64O047KTOA	ALL DAY ALLERGY (CETIRIZINE HCL) CAPSULE [TOP CARE (TOPCO ASSOCIATES LLC)]	1
CETIRIZINE	ACTIVE MOIETY	YO7261ME24	ALL DAY ALLERGY (CETIRIZINE HCL) CAPSULE [TOP CARE (TOPCO ASSOCIATES LLC)]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ALL DAY ALLERGY (CETIRIZINE HCL) CAPSULE [TOP CARE (TOPCO ASSOCIATES LLC)]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	ALL DAY ALLERGY (CETIRIZINE HCL) CAPSULE [TOP CARE (TOPCO ASSOCIATES LLC)]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ALL DAY ALLERGY (CETIRIZINE HCL) CAPSULE [TOP CARE (TOPCO ASSOCIATES LLC)]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	ALL DAY ALLERGY (CETIRIZINE HCL) CAPSULE [TOP CARE (TOPCO ASSOCIATES LLC)]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	ALL DAY ALLERGY (CETIRIZINE HCL) CAPSULE [TOP CARE (TOPCO ASSOCIATES LLC)]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	ALL DAY ALLERGY (CETIRIZINE HCL) CAPSULE [TOP CARE (TOPCO ASSOCIATES LLC)]	1
SORBITAN	INACTIVE INGREDIENT	6O92ICV9RU	ALL DAY ALLERGY (CETIRIZINE HCL) CAPSULE [TOP CARE (TOPCO ASSOCIATES LLC)]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	ALL DAY ALLERGY (CETIRIZINE HCL) CAPSULE [TOP CARE (TOPCO ASSOCIATES LLC)]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ALL DAY ALLERGY (CETIRIZINE HCL) CAPSULE [TOP CARE (TOPCO ASSOCIATES LLC)]	1

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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief	CETIRIZINE HCL	Whole Foods Market, INC.	453b20b5-72a7-ac09-e063-6394a90afc4b	2026-06-22	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
Cetirizine HCl	CETIRIZINE HCL	PUBLIX SUPER MARKETS INC	4d652305-67f3-33f3-e063-6294a90a367e	2026-06-22	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
Cetirizine HCl	CETIRIZINE HCL	AMERISOURCE BERGEN	518ed897-7365-0520-e063-6394a90a06d6	2026-05-11	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
Cetirizine HCl	CETIRIZINE HCL	TOP CARE (Topco Associates LLC)	3363bd32-cac6-e10c-e063-6294a90a2638	2026-05-11	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
Cetirizine HCl	CETIRIZINE HCL	Meijer Distribution Inc	3143de16-2006-ec2e-e063-6294a90a1f67	2026-04-20	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
Cetirizine HCl	CETIRIZINE HCL	WALGREEN COMPANY	4a181a38-ac94-8d00-e063-6394a90a6bf6	2026-04-20	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
Cetirizine HCl	CETIRIZINE HCL	Bionpharma Inc.	4fe8f764-a8e2-a432-e063-6294a90a33b0	2026-04-20	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
Cetirizine HCl	CETIRIZINE HCL	TARGET Corporation	363845a9-c379-16a7-e063-6394a90a011a	2026-04-20	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
Cetirizine HCl	CETIRIZINE HCL	KROGER COMPANY	33f181f8-6e0d-b89b-e063-6394a90aeae7	2026-04-20	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
Cetirizine HCl	CETIRIZINE HCL	Bionpharma Inc.	2c2c4828-0479-4ff3-b2b0-dde5fa74efaf	2025-12-16	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
Cetirizine HCl	CETIRIZINE HCL	TARGET Corporation	e39a1a4f-c786-479a-9c11-aaf591810fe7	2025-12-16	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
Cetirizine HCl	CETIRIZINE HCL	KROGER COMPANY	63ddeea4-d701-42b2-bcb7-81c0e43eb013	2025-11-24	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
Cetirizine HCl	CETIRIZINE HCL	Meijer Distribution Inc	235bf16e-4c23-95f8-e063-6394a90a62d5	2024-11-25	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
Cetirizine HCl	CETIRIZINE HCL	DOLGENCORP INC	235c2640-8d6a-249d-e063-6394a90a132a	2024-11-25	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
Cetirizine HCl	CETIRIZINE HCL	TOP CARE (Topco Associates LLC)	2033e2c3-81af-b1cf-e063-6394a90adbc5	2024-11-22	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
Cetirizine HCl	CETIRIZINE HCL	PUBLIX SUPER MARKETS INC	1ab5c526-b5fd-fca0-e063-6294a90ac54a	2024-10-03	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
24 HOUR ALLERGY	CETIRIZINE HCL	Walgreens	f3168f2c-27a7-4dd7-9770-e91443a580f1	2024-04-01	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
Cetirizine HCl	CETIRIZINE HCL	Northeast Pharma	0647ef4c-8912-9f44-e063-6294a90ae3a6	2023-09-26	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
All Day Allergy Relief	CETIRIZINE HCL	CHAIN DRUG MARKETING ASSOCIATION INC.	ec81dc4c-74c0-4719-be5d-686d545f4003	2022-12-29	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429
Allergy Relief	CETIRIZINE HCL	DISCOUNT DRUG MART, INC.	89c77f0d-a325-4f8f-9142-98c0d41de8b1	2022-12-29	Warnings	Exact identifier application applno (NDA): 022429 application number: NDA022429

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-211-25	36800021125	1 BOTTLE, PLASTIC in 1 BOX (36800-211-25) > 25 CAPSULE in 1 BOTTLE, PLASTIC	2013-04-30	2021-12-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	TOP CARE (Topco Associates LLC) \| P & L Development, LLC	2019-10-14	HUMAN OTC DRUG LABEL	3