basic care allergy relief

Product NDC
72288-241
11-digit product format
722880241
Labeler code
72288
Product ID
72288-241_fe965a15-7789-4ea5-b33e-2d3513409e1a
Type
HUMAN OTC DRUG
Nonproprietary name
levocetirizine dihydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amazon.com Services LLC
Application
ANDA211983
Marketing category
ANDA
Marketing start
2020-10-29
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 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
basic care allergy relief
Listing expiration
2026-12-31

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
fe965a15-7789-4ea5-b33e-2d3513409e1aAvailable 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
72288-241-27basic care allergy relief80 in 1 BOTTLETABLET, FILM COATED801
72288-241-27basic care allergy relief1 in 1 CARTONTABLET, FILM COATED11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-241BASIC CARE ALLERGY RELIEF (LEVOCETIRIZINE DIHYDROCHLORIDE) TABLET, FILM COATED [AMAZON.COM SERVICES LLC]1Current NDC, Legacy NDC, 2 package rows20201106_fe965a15-7789-4ea5-b33e-2d3513409e1a.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
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
ndc (product): 72288-241

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855172levocetirizine dihydrochloride 5 MG Oral TabletPSNfe965a15-7789-4ea5-b33e-2d3513409e1a1
855172levocetirizine dihydrochloride 5 MG Oral TabletSCDfe965a15-7789-4ea5-b33e-2d3513409e1a1
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSYfe965a15-7789-4ea5-b33e-2d3513409e1a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72288-241-27722880241271 BOTTLE in 1 CARTON (72288-241-27) / 80 TABLET, FILM COATED in 1 BOTTLE1 bottle2020-10-290000-00-00NoNoCurrent