Allergy Relief 24HR

Product NDC: 73226-001
Requested package NDC: 73226-001-00
11-digit product format: 732260001
Labeler code: 73226
Product ID: 73226-001_b8a3181d-990f-454f-e053-2995a90a96c0
Type: HUMAN OTC DRUG
Nonproprietary name: Levocetirizine dihydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Vitesse Pharma LLC
Application: ANDA211551
Marketing category: ANDA
Marketing start: 2019-07-02
Marketing end: 0000-00-00
Substance: LEVOCETIRIZINE DIHYDROCHLORIDE
Active strength: 5 mg/1
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	73226-001	73226-001-00	I	Inactivated by FDA		2026-08-11

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 · 15 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…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A211551-001	LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL			2018-11-20

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	A211551-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211551-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-11-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211551-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-11-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211551-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-11-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211551-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-11-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211551-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-11-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211551-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-11-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211551-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-11-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211551-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-11-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211551-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-11-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211551-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-11-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211551-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-11-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211551-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-11-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211551-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-11-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211551-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-11-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211551-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-11-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211551-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-11-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211551-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-11-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211551-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-11-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211551-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-11-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211551-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-11-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211551-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-11-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211551-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-11-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211551-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-11-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211551-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-11-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211551-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-11-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211551-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-11-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211551-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-11-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211551-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-11-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211551-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-11-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211551-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-11-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211551-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-11-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211551-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-11-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211551-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-11-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211551-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-11-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211551-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-11-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211551-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-11-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211551-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-11-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211551-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-11-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211551-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2018-11-20	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
36cf9111-9cc4-8f59-a74c-0c1cfbd4a760	Product name	7	20190702

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
73226-001-00	2023-01-30	C162847	48780-1	f386c64a-1ee8-0266-e053-dadaa90a7c1a	Allergy Relief 24HR

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
73226-001-00	Allergy Relief 24HR	40 in 1 CARTON	TABLET	40		3
73226-001-00	Allergy Relief 24HR	2500 in 1 BAG	TABLET	2500		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73226-001	ALLERGY RELIEF 24HR (LEVOCETIRIZINE DIHYDROCHLORIDE) TABLET [VITESSE PHARMA LLC]	3	Legacy NDC, 2 package rows	20210112_64077f58-3e20-4af0-89b8-ca50f43a32f6.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Micro Labs Limited	78ff8e86-ee5b-4626-aa81-49e974febf1d	2025-02-16	Warnings	Exact identifier application applno (ANDA): 211551 application number: ANDA211551
Allergy Relief 24HR	LEVOCETIRIZINE DIHYDROCHLORIDE	VELOCITY PHARMA LLC	8ba208dc-34fe-453a-8658-ed4f232e1a94	2024-10-29	Warnings	Exact identifier application applno (ANDA): 211551 application number: ANDA211551

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOD6A38AGA	LEVOCETIRIZINE DIHYDROCHLORIDE	130018-87-0	LEVOCETIRIZINE DIHYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
855172	levocetirizine dihydrochloride 5 MG Oral Tablet	PSN	64077f58-3e20-4af0-89b8-ca50f43a32f6	3
855172	levocetirizine dihydrochloride 5 MG Oral Tablet	SCD	64077f58-3e20-4af0-89b8-ca50f43a32f6	3
855172	levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet	SY	64077f58-3e20-4af0-89b8-ca50f43a32f6	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
73226-001-00	73226000100	40 BAG in 1 CARTON (73226-001-00) > 2500 TABLET in 1 BAG	40 bag	2019-07-02	0000-00-00	No	No	Current