allergy relief

Product NDC: 0363-3901
11-digit product format: 003633901
Labeler code: 0363
Product ID: 0363-3901_9f9913a7-9054-4d73-b480-e9a5f6446373
Type: HUMAN OTC DRUG
Nonproprietary name: levocetirizine dihydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Walgreen Company
Application: ANDA211983
Marketing category: ANDA
Marketing start: 2021-09-23
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: 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
A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL			2019-03-28

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	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211983-001	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	TABLET / ORAL	2019-03-28	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: allergy relief
Listing expiration: 2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SOD6A38AGA	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
855172	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
5033f8e3-c1c4-44e9-a774-703d9b04e82c	Available on FDA.report

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
0363-3901-01	allergy relief	1 in 1 CARTON	TABLET, FILM COATED	1	3
0363-3901-01	allergy relief	35 in 1 BOTTLE	TABLET, FILM COATED	35	3
0363-3901-27	allergy relief	80 in 1 BOTTLE	TABLET, FILM COATED	80	3
0363-3901-27	allergy relief	1 in 1 CARTON	TABLET, FILM COATED	1	3
0363-3901-76	allergy relief	120 in 1 BOTTLE	TABLET, FILM COATED	120	3
0363-3901-76	allergy relief	1 in 1 CARTON	TABLET, FILM COATED	1	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0363-3901	ALLERGY RELIEF (LEVOCETIRIZINE DIHYDROCHLORIDE) TABLET, FILM COATED [WALGREEN COMPANY]	2	Current NDC, Legacy NDC, 6 package rows	20211001_5033f8e3-c1c4-44e9-a774-703d9b04e82c.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ALLERGY RELIEF	LEVOCETIRIZINE DIHYDROCHLORIDE	Amazon.com Services LLC	9ba39415-34af-49ca-b5cb-464e75517917	2026-08-12	Warnings	Exact identifier application applno (ANDA): 211983 application number: ANDA211983
good sense levocetirizine	LEVOCETIRIZINE DIHYDROCHLORIDE	L. Perrigo Company	0b482364-a00a-4b95-975a-f403a3ae4d2e	2026-07-13	Warnings	Exact identifier application applno (ANDA): 211983 application number: ANDA211983
allergy relief	LEVOCETIRIZINE DIHYDROCHLORIDE	Rite Aid Corporation	c6f826a4-cb8d-4a9f-99cc-5041f65801ca	2025-10-09	Warnings	Exact identifier application applno (ANDA): 211983 application number: ANDA211983
allergy relief	LEVOCETIRIZINE DIHYDROCHLORIDE	Walgreen Company	5033f8e3-c1c4-44e9-a774-703d9b04e82c	2025-07-16	Warnings	Exact identifier application applno (ANDA): 211983 application number: ANDA211983 ndc (product): 0363-3901
Allergy Relief	LEVOCETIRIZINE DIHYDROCHLORIDE	Meijer Distribution Inc	ca6d0ba0-96af-41e9-a3e9-0c7783db3011	2025-05-20	Warnings	Exact identifier application applno (ANDA): 211983 application number: ANDA211983
Topcare All Day Allergy	LEVOCETIRIZINE DIHYDROCHLORIDE	Topco Associates LLC	393616df-52f1-4e77-b69c-8239ca193d5b	2022-02-21	Warnings	Exact identifier application applno (ANDA): 211983 application number: ANDA211983
DG Health Allergy Relief	LEVOCETIRIZINE DIHYDROCHLORIDE	Dolgencorp, LLC	470fee97-daab-4967-9c0e-77bacfb2ccd8	2021-06-24	Warnings	Exact identifier application applno (ANDA): 211983 application number: ANDA211983
basic care allergy relief	LEVOCETIRIZINE DIHYDROCHLORIDE	Amazon.com Services LLC	fe965a15-7789-4ea5-b33e-2d3513409e1a	2020-11-02	Warnings	Exact identifier application applno (ANDA): 211983 application number: ANDA211983

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	5033f8e3-c1c4-44e9-a774-703d9b04e82c	3
855172	levocetirizine dihydrochloride 5 MG Oral Tablet	SCD	5033f8e3-c1c4-44e9-a774-703d9b04e82c	3
855172	levocetirizine dihydrochloride 5 MG 24 HR Oral Tablet	SY	5033f8e3-c1c4-44e9-a774-703d9b04e82c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0363-3901-01	00363390101	1 BOTTLE in 1 CARTON (0363-3901-01) / 35 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2021-09-23	0000-00-00	No	No	Current
0363-3901-27	00363390127	1 BOTTLE in 1 CARTON (0363-3901-27) / 80 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2021-09-23	0000-00-00	No	No	Current
0363-3901-76	00363390176	1 BOTTLE in 1 CARTON (0363-3901-76) / 120 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2021-09-23	0000-00-00	No	No	Current