allergy relief

Product NDC
11822-0241
Requested package NDC
11822-0241-0
11-digit product format
118220241
Labeler code
11822
Product ID
11822-0241_b1f546c9-0566-4c68-bf78-e806284abd96
Type
HUMAN OTC DRUG
Nonproprietary name
levocetirizine dihydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rite Aid Corporation
Application
ANDA211983
Marketing category
ANDA
Marketing start
2020-10-05
Marketing end
2026-11-30
Substance
LEVOCETIRIZINE DIHYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage11822-024111822-0241-0DDiscontinued by firm2026-08-03

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage11822-024111822-0241-0DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211983-001LEVOCETIRIZINE DIHYDROCHLORIDELEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-283f01610625f2…
2019-09-15 20:21 UTC2019-09A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
allergy relief

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LEVOCETIRIZINE DIHYDROCHLORIDE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOD6A38AGAInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
855172Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c6f826a4-cb8d-4a9f-99cc-5041f65801caAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
36cf9111-9cc4-8f59-a74c-0c1cfbd4a760Product name720190702

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-0241-0allergy relief35 in 1 BOTTLETABLET, FILM COATED355
11822-0241-0allergy relief1 in 1 CARTONTABLET, FILM COATED15
11822-0241-1allergy relief1 in 1 CARTONTABLET, FILM COATED15
11822-0241-1allergy relief120 in 1 BOTTLETABLET, FILM COATED1205
11822-0241-2allergy relief10 in 1 CARTONTABLET, FILM COATED105
11822-0241-2allergy relief1 in 1 BLISTER PACKTABLET, FILM COATED15
11822-0241-3allergy relief1 in 1 CARTONTABLET, FILM COATED15
11822-0241-3allergy relief80 in 1 BOTTLETABLET, FILM COATED805

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-0241ALLERGY RELIEF (LEVOCETIRIZINE DIHYDROCHLORIDE) TABLET, FILM COATED [RITE AID CORPORATION]4Current NDC, Legacy NDC, 8 package rows20230829_c6f826a4-cb8d-4a9f-99cc-5041f65801ca.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
good sense levocetirizineLEVOCETIRIZINE DIHYDROCHLORIDEL. Perrigo Company0b482364-a00a-4b95-975a-f403a3ae4d2e2026-07-13WarningsExact identifier
application applno (ANDA): 211983
application number: ANDA211983
allergy reliefLEVOCETIRIZINE DIHYDROCHLORIDERite Aid Corporationc6f826a4-cb8d-4a9f-99cc-5041f65801ca2025-10-09WarningsExact identifier
application applno (ANDA): 211983
application number: ANDA211983
ndc (package): 11822-0241-0
ndc (product): 11822-0241
ndc11 (package): 11822024100
allergy reliefLEVOCETIRIZINE DIHYDROCHLORIDEWalgreen Company5033f8e3-c1c4-44e9-a774-703d9b04e82c2025-07-16WarningsExact identifier
application applno (ANDA): 211983
application number: ANDA211983
Allergy ReliefLEVOCETIRIZINE DIHYDROCHLORIDEMeijer Distribution Incca6d0ba0-96af-41e9-a3e9-0c7783db30112025-05-20WarningsExact identifier
application applno (ANDA): 211983
application number: ANDA211983
Topcare All Day AllergyLEVOCETIRIZINE DIHYDROCHLORIDETopco Associates LLC393616df-52f1-4e77-b69c-8239ca193d5b2022-02-21WarningsExact identifier
application applno (ANDA): 211983
application number: ANDA211983
DG Health Allergy ReliefLEVOCETIRIZINE DIHYDROCHLORIDEDolgencorp, LLC470fee97-daab-4967-9c0e-77bacfb2ccd82021-06-24WarningsExact identifier
application applno (ANDA): 211983
application number: ANDA211983
basic care allergy reliefLEVOCETIRIZINE DIHYDROCHLORIDEAmazon.com Services LLCfe965a15-7789-4ea5-b33e-2d3513409e1a2020-11-02WarningsExact identifier
application applno (ANDA): 211983
application number: ANDA211983

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855172levocetirizine dihydrochloride 5 MG Oral TabletPSNc6f826a4-cb8d-4a9f-99cc-5041f65801ca5
855172levocetirizine dihydrochloride 5 MG Oral TabletSCDc6f826a4-cb8d-4a9f-99cc-5041f65801ca5
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSYc6f826a4-cb8d-4a9f-99cc-5041f65801ca5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11822-0241-0118220241001 BOTTLE in 1 CARTON (11822-0241-0) > 35 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-10-050000-00-00NoNoCurrent