FDA.reportPublic FDA data

Cetirizine Hydrochloride

Product NDC
70000-0047
11-digit product format
700000047
Labeler code
70000
Product ID
70000-0047_5c5725c9-4879-424d-829c-44017284977a
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride Allergy
Dosage form
TABLET
Route
ORAL
Labeler
LEADER/ CARDINAL HEALTH 110, INC.
Application
ANDA090760
Marketing category
ANDA
Marketing start
2020-03-26
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 1.

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
A090760-001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2015-08-05
A090760-002CETIRIZINE HYDROCHLORIDE HIVES RELIEFCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2015-08-05
A090760-003CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2015-08-05
A090760-004CETIRIZINE HYDROCHLORIDE HIVES RELIEFCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2015-08-05

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 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090760-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2015-08-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090760-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2015-08-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090760-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2015-08-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090760-004CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2015-08-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090760-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2015-08-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090760-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2015-08-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090760-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2015-08-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090760-004CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2015-08-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A090760-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2015-08-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090760-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2015-08-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090760-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2015-08-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090760-004CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2015-08-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090760-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2015-08-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090760-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2015-08-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090760-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2015-08-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090760-004CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2015-08-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090760-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2015-08-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090760-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2015-08-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090760-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2015-08-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090760-004CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2015-08-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090760-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2015-08-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090760-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2015-08-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090760-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2015-08-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090760-004CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2015-08-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090760-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2015-08-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090760-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2015-08-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090760-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2015-08-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090760-004CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2015-08-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090760-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2015-08-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090760-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2015-08-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090760-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2015-08-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090760-004CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2015-08-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090760-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2015-08-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090760-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2015-08-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090760-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2015-08-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090760-004CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2015-08-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090760-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2015-08-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A090760-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET / ORAL2015-08-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A090760-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2015-08-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A090760-004CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET / ORAL2015-08-05d06236e962d9…

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
0cab7aa8-ded3-46f1-b801-2663cc9b0173Available 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
70000-0047-1Cetirizine Hydrochloride365 in 1 BOTTLETABLET3654

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0047CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE ALLERGY) TABLET [CARDINAL HEALTH]3Current NDC, Legacy NDC, 1 package rows20210617_0cab7aa8-ded3-46f1-b801-2663cc9b0173.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 · 18 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEKROGER COMPANYb92d959d-dd35-b2a3-e053-2995a90af3ff2026-07-15WarningsExact identifier
application applno (ANDA): 090760
application number: ANDA090760
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEAurohealth LLCc1ae7bb1-e154-4745-b01e-bc91d50d35c82026-05-25WarningsExact identifier
application applno (ANDA): 090760
application number: ANDA090760
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.73122009-531b-4929-bf57-494a6fc65b732026-03-25WarningsExact identifier
application applno (ANDA): 090760
application number: ANDA090760
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEA-S Medication Solutionsae02b16b-77dc-4bd6-8c07-e734fb4484922026-01-29WarningsExact identifier
application applno (ANDA): 090760
application number: ANDA090760
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEA-S Medication Solutions158d3bcc-6a7f-4ee7-b181-be3fd6f94f8d2026-01-29WarningsExact identifier
application applno (ANDA): 090760
application number: ANDA090760
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEBluePoint Laboratoriesa86fbe45-08db-bddf-e053-2a95a90aa7922025-10-30WarningsExact identifier
application applno (ANDA): 090760
application number: ANDA090760
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDE ALLERGYLEADER/ CARDINAL HEALTH 110, INC.0cab7aa8-ded3-46f1-b801-2663cc9b01732025-10-03WarningsExact identifier
application applno (ANDA): 090760
application number: ANDA090760
ndc (product): 70000-0047
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEINNOVUS PHARMACEUTICALS, INC.89db2c96-62f6-4e75-8f0d-321b44094c602025-04-28WarningsExact identifier
application applno (ANDA): 090760
application number: ANDA090760
Cetirizine Hydrochloride (Hives Relief)CETIRIZINE HYDROCHLORIDEAurohealth LLC2b9ac0cd-9dd1-4f78-a16d-9d40f5091c0a2025-02-10WarningsExact identifier
application applno (ANDA): 090760
application number: ANDA090760
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEAurohealth LLC3cf969e6-6bc9-4dae-ab6a-b24c0fc46b252024-09-13WarningsExact identifier
application applno (ANDA): 090760
application number: ANDA090760
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEA-S Medication Solutions42c9636f-07af-44a3-8d84-c11e1b57783a2024-07-02WarningsExact identifier
application applno (ANDA): 090760
application number: ANDA090760
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDENorthStar Rx LLCc9d1e26f-c95a-4991-95fa-9ed6ed484fe22024-06-26WarningsExact identifier
application applno (ANDA): 090760
application number: ANDA090760
AMAZON BASIC CARE ALL DAY ALLERGY RELIEFCETIRIZINE HYDROCHLORIDEAmazon.com Services LLC113e66f1-b922-8533-e063-6294a90ab30e2024-05-10WarningsExact identifier
application applno (ANDA): 090760
application number: ANDA090760
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDECVS Pharmacy, Inc.e340cd4b-5413-42c6-a956-eb15c3807aeb2024-03-29WarningsExact identifier
application applno (ANDA): 090760
application number: ANDA090760
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEProficient Rx LPd69083c4-b028-453c-8235-560b40ad358b2024-03-01WarningsExact identifier
application applno (ANDA): 090760
application number: ANDA090760
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEAurohealth LLC7d214cba-951d-464e-b37e-e83098944fe62024-01-11WarningsExact identifier
application applno (ANDA): 090760
application number: ANDA090760
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEWALGREEN CO.c0165b0e-d5e9-a028-e053-2a95a90ab4312023-05-25WarningsExact identifier
application applno (ANDA): 090760
application number: ANDA090760
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEBetter Living Brands, LLCf7e16d96-4f23-cbca-e053-6394a90aef4e2023-05-19WarningsExact identifier
application applno (ANDA): 090760
application number: ANDA090760

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN0cab7aa8-ded3-46f1-b801-2663cc9b01734
1014678cetirizine hydrochloride 10 MG Oral TabletSCD0cab7aa8-ded3-46f1-b801-2663cc9b01734
1014678cetirizine HCl 10 MG Oral TabletSY0cab7aa8-ded3-46f1-b801-2663cc9b01734

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0047-170000004701365 TABLET in 1 BOTTLE (70000-0047-1) 365 tablet2020-03-260000-00-00NoNoCurrent