ALLERGY RELIEF

Product NDC: 73581-201
Requested package NDC: 73581-201-36
11-digit product format: 735810201
Labeler code: 73581
Product ID: 73581-201_5bc38f40-5a86-6dba-e063-6394a90ab9bd
Type: HUMAN OTC DRUG
Nonproprietary name: LEVOCETIRIZINE DIHYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: YYBA CORP
Application: ANDA213513
Marketing category: ANDA
Marketing start: 2020-06-30
Substance: LEVOCETIRIZINE DIHYDROCHLORIDE
Active strength: 5 mg/1
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL			2020-04-29

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213513-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2020-04-29	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: ALLERGY RELIEF
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LEVOCETIRIZINE DIHYDROCHLORIDE	5 mg/1

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
73581-201-10	ALLERGY RELIEF	1 in 1 BOX	TABLET	1	6
73581-201-10	ALLERGY RELIEF	10 in 1 BOTTLE	TABLET	10	6
73581-201-18	ALLERGY RELIEF	1 in 1 BOX	TABLET	1	6
73581-201-18	ALLERGY RELIEF	18 in 1 BOTTLE	TABLET	18	6
73581-201-80	ALLERGY RELIEF	180 in 1 BOTTLE	TABLET	180	6
73581-201-80	ALLERGY RELIEF	1 in 1 BOX	TABLET	1	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73581-201	ALLERGY RELIEF (LEVOCETIRIZINE DIHYDROCHLORIDE) TABLET [YYBA CORP]	4	Current NDC, Legacy NDC, 6 package rows	20241004_8ee69332-742d-4071-95df-84bc42e170e7.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Goodmeds Levocetirizine Dihydrochloride 5mg 365 count	LEVOCETIRIZINE DIHYDROCHLORIDE 5MG	Cabinet Health P.B.C.	54f34304-952e-2f07-e063-6394a90a80ee	2026-06-23	Warnings	Exact identifier application applno (ANDA): 213513 application number: ANDA213513
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Farmacias De Similares TX LLC	4ed17484-5609-d993-e063-6294a90a82a2	2026-04-06	Warnings	Exact identifier application applno (ANDA): 213513 application number: ANDA213513
Curist Allergy Relief	LEVOCETIRIZINE DIHYDROCHLORIDE 5 MG	Little Pharma, Inc.	f2a2a5bc-2efa-c550-e053-2a95a90a55ff	2026-03-05	Warnings	Exact identifier application applno (ANDA): 213513 application number: ANDA213513
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Sportpharm LLC	8c00c74f-4377-4f2c-943e-e55afa5a824f	2026-02-14		Exact identifier application applno (ANDA): 213513 application number: ANDA213513
Curist Allergy Relief	LEVOCETIRIZINE DIHYDROCHLORIDE 5 MG	Little Pharma, Inc.	feabf140-e283-dcd5-e053-6394a90a2917	2025-04-16	Warnings	Exact identifier application applno (ANDA): 213513 application number: ANDA213513
Allery Relief 24HR	ALLERY RELIEF 24HR	Allegiant Health	c523c210-b1c4-4049-9c72-2b31c9c93137	2024-04-02	Warnings	Exact identifier application applno (ANDA): 213513 application number: ANDA213513
Levocetirizine Dihydrochloride	LEVOCETIRIZINE DIHYDROCHLORIDE	Camber Consumer Care Inc	be72dafb-62ae-40b2-874f-1d8920fad19d	2020-11-30		Exact identifier application applno (ANDA): 213513 application number: ANDA213513

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	8ee69332-742d-4071-95df-84bc42e170e7	6
855172	levocetirizine dihydrochloride 5 MG Oral Tablet	SCD	8ee69332-742d-4071-95df-84bc42e170e7	6
855172	levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet	SY	8ee69332-742d-4071-95df-84bc42e170e7	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
73581-201-36	73581020136	2 BOTTLE in 1 CARTON (73581-201-36) / 180 TABLET in 1 BOTTLE	2 bottle	2020-06-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
YYBA - WELMATE ALLERGY RELIEF - LEVOCETRIZINE DIHYDROCHLORIDE, 5 MG (73581-201)	YYBA CORP	2026-09-18	HUMAN OTC DRUG LABEL	7