FDA.reportPublic FDA data

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 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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
ndc (product): 0363-3901
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

Additional Listing Data#

Finished product
Yes
Brand name base
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
5033f8e3-c1c4-44e9-a774-703d9b04e82cAvailable 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
0363-3901-01allergy relief1 in 1 CARTONTABLET, FILM COATED13
0363-3901-01allergy relief35 in 1 BOTTLETABLET, FILM COATED353
0363-3901-27allergy relief80 in 1 BOTTLETABLET, FILM COATED803
0363-3901-27allergy relief1 in 1 CARTONTABLET, FILM COATED13
0363-3901-76allergy relief120 in 1 BOTTLETABLET, FILM COATED1203
0363-3901-76allergy relief1 in 1 CARTONTABLET, FILM COATED13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-3901ALLERGY RELIEF (LEVOCETIRIZINE DIHYDROCHLORIDE) TABLET, FILM COATED [WALGREEN COMPANY]2Current NDC, Legacy NDC, 6 package rows20211001_5033f8e3-c1c4-44e9-a774-703d9b04e82c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855172levocetirizine dihydrochloride 5 MG Oral TabletPSN5033f8e3-c1c4-44e9-a774-703d9b04e82c3
855172levocetirizine dihydrochloride 5 MG Oral TabletSCD5033f8e3-c1c4-44e9-a774-703d9b04e82c3
855172levocetirizine dihydrochloride 5 MG 24 HR Oral TabletSY5033f8e3-c1c4-44e9-a774-703d9b04e82c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-3901-01003633901011 BOTTLE in 1 CARTON (0363-3901-01) / 35 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-09-230000-00-00NoNoCurrent
0363-3901-27003633901271 BOTTLE in 1 CARTON (0363-3901-27) / 80 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-09-230000-00-00NoNoCurrent
0363-3901-76003633901761 BOTTLE in 1 CARTON (0363-3901-76) / 120 TABLET, FILM COATED in 1 BOTTLE1 bottle2021-09-230000-00-00NoNoCurrent