FDA.reportPublic FDA data

cetirizine hydrochloride

Product NDC
45802-919
11-digit product format
458020919
Labeler code
45802
Product ID
45802-919_431bdf74-dfe3-4e4f-91e9-2b638ada6d47
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
ANDA078336
Marketing category
ANDA
Marketing start
2007-12-27
Substance
CETIRIZINE HYDROCHLORIDE
Active strength
10 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 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078336-001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2007-12-27
A078336-002CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2007-12-27
A078336-003CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2007-12-27
A078336-004CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2007-12-27

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 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2784e616aacf4f…
2026-09-14 22:38:342026-08A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2784e616aacf4f…
2026-09-14 22:38:342026-08A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-2784e616aacf4f…
2026-09-14 22:38:342026-08A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-2784e616aacf4f…
2026-08-18 06:07:402026-07A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27caaa826d4ba7…
2026-08-18 06:07:402026-07A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27caaa826d4ba7…
2026-08-18 06:07:402026-07A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-27caaa826d4ba7…
2026-08-18 06:07:402026-07A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-275bbf6a4d5a75…

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
cetirizine hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
64O047KTOAInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1014678Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
91fe3ab8-c155-4482-9f06-f029d3563aadAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-919-39cetirizine hydrochloride1 in 1 CARTONTABLET, FILM COATED16
45802-919-39cetirizine hydrochloride30 in 1 BOTTLETABLET, FILM COATED306
45802-919-87cetirizine hydrochloride1 in 1 CARTONTABLET, FILM COATED16
45802-919-87cetirizine hydrochloride300 in 1 BOTTLETABLET, FILM COATED3006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-919-39EA - Each45802-919b2bd0f9b-dbad-4ac2-9772-125036bd70ee12012-07-24
45802-919-87EA - Each45802-919a145968b-3648-4a2a-9d43-0a5861dc16cb12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOACETIRIZINE (CETIRIZINE HYDROCHLORIDE) TABLET [BRYANT RANCH PREPACK]3
CETIRIZINEACTIVE MOIETYYO7261ME24CETIRIZINE (CETIRIZINE HYDROCHLORIDE) TABLET [BRYANT RANCH PREPACK]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCETIRIZINE (CETIRIZINE HYDROCHLORIDE) TABLET [BRYANT RANCH PREPACK]3
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOACETIRIZINE HYDROCHLORIDE TABLET [PERRIGO NEW YORK INC]1
CETIRIZINEACTIVE MOIETYYO7261ME24CETIRIZINE HYDROCHLORIDE TABLET [PERRIGO NEW YORK INC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCETIRIZINE HYDROCHLORIDE TABLET [PERRIGO NEW YORK INC]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GCETIRIZINE HYDROCHLORIDE TABLET [PERRIGO NEW YORK INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CETIRIZINE HYDROCHLORIDE TABLET [PERRIGO NEW YORK INC]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IECETIRIZINE HYDROCHLORIDE TABLET [PERRIGO NEW YORK INC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACETIRIZINE HYDROCHLORIDE TABLET [PERRIGO NEW YORK INC]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ECETIRIZINE HYDROCHLORIDE TABLET [PERRIGO NEW YORK INC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCETIRIZINE HYDROCHLORIDE TABLET [PERRIGO NEW YORK INC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCETIRIZINE HYDROCHLORIDE TABLET [PERRIGO NEW YORK INC]1
TRIACETININACTIVE INGREDIENTXHX3C3X673CETIRIZINE HYDROCHLORIDE TABLET [PERRIGO NEW YORK INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-919CETIRIZINE HYDROCHLORIDE TABLET, FILM COATED [PADAGIS ISRAEL PHARMACEUTICALS LTD]6Current NDC, Legacy NDC, 4 package rows20250313_91fe3ab8-c155-4482-9f06-f029d3563aad.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 3 of 3 · 44 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
betr remedies all day allergy reliefCETIRIZINE HYDROCHLORIDELive Betr LLC4a017852-db01-4085-8947-d92a19ec4e5c2023-05-10WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEProficient Rx LP198ca875-bb8a-49d5-8809-7121ba1193812022-04-01WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
rexall all day allergy reliefCETIRIZINE HYDROCHLORIDEDolgencorp, LLC4d79fb74-1895-4efe-8016-c0dd5ed10f7a2021-06-01WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
basic care all day allergyCETIRIZINE HYDROCHLORIDEAmazon.com Services LLCaf8ff570-8f72-4343-b7e1-e977221f5b012021-04-09WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNae93976d-de9b-43a6-b299-ce1f1ae8d6f8107
1014678cetirizine hydrochloride 10 MG Oral TabletSCDae93976d-de9b-43a6-b299-ce1f1ae8d6f8107
1014678cetirizine HCl 10 MG Oral TabletSYae93976d-de9b-43a6-b299-ce1f1ae8d6f8107
1014678cetirizine HCl 10 MG Oral TabletPSN198ca875-bb8a-49d5-8809-7121ba1193818
1014678cetirizine hydrochloride 10 MG Oral TabletSCD198ca875-bb8a-49d5-8809-7121ba1193818
1014678cetirizine HCl 10 MG Oral TabletSY198ca875-bb8a-49d5-8809-7121ba1193818
1014678cetirizine HCl 10 MG Oral TabletPSNaf7513ae-5107-477c-a7da-0ded9d53a55c7
1014678cetirizine hydrochloride 10 MG Oral TabletSCDaf7513ae-5107-477c-a7da-0ded9d53a55c7
1014678cetirizine HCl 10 MG Oral TabletSYaf7513ae-5107-477c-a7da-0ded9d53a55c7
1014678cetirizine HCl 10 MG Oral TabletPSN91fe3ab8-c155-4482-9f06-f029d3563aad6
1014678cetirizine hydrochloride 10 MG Oral TabletSCD91fe3ab8-c155-4482-9f06-f029d3563aad6
1014678cetirizine HCl 10 MG Oral TabletSY91fe3ab8-c155-4482-9f06-f029d3563aad6
1014678cetirizine HCl 10 MG Oral TabletPSNe6f4e9ad-65fc-422c-98b8-22745aefc5f51
1014678cetirizine HCl 10 MG Oral TabletPSNa462f9c0-45ef-49b1-b0d8-a02a75a4b7311
1014678cetirizine HCl 10 MG Oral TabletPSN6a707324-b32b-9741-e053-2a91aa0a2af21
1014678cetirizine HCl 10 MG Oral TabletPSN25db4ca0-0c25-f3b6-e063-6394a90a88511
1014678cetirizine hydrochloride 10 MG Oral TabletSCDa462f9c0-45ef-49b1-b0d8-a02a75a4b7311
1014678cetirizine hydrochloride 10 MG Oral TabletSCD6a707324-b32b-9741-e053-2a91aa0a2af21
1014678cetirizine hydrochloride 10 MG Oral TabletSCD25db4ca0-0c25-f3b6-e063-6394a90a88511
1014678cetirizine hydrochloride 10 MG Oral TabletSCDe6f4e9ad-65fc-422c-98b8-22745aefc5f51
1014678cetirizine HCl 10 MG Oral TabletSYa462f9c0-45ef-49b1-b0d8-a02a75a4b7311
1014678cetirizine HCl 10 MG Oral TabletSY6a707324-b32b-9741-e053-2a91aa0a2af21
1014678cetirizine HCl 10 MG Oral TabletSY25db4ca0-0c25-f3b6-e063-6394a90a88511
1014678cetirizine HCl 10 MG Oral TabletSYe6f4e9ad-65fc-422c-98b8-22745aefc5f51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-919-39458020919391 BOTTLE in 1 CARTON (45802-919-39) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2008-10-150000-00-00NoNoCurrent
45802-919-87458020919871 BOTTLE in 1 CARTON (45802-919-87) / 300 TABLET, FILM COATED in 1 BOTTLE1 bottle2007-12-270000-00-00NoNoCurrent