Cetirizine Hydrochloride (Hives Relief)

Product NDC
58602-446
11-digit product format
586020446
Labeler code
58602
Product ID
58602-446_5ebdf17c-288b-4fed-89c8-7d1f42a128d0
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aurohealth LLC
Application
ANDA090760
Marketing category
ANDA
Marketing start
2015-08-05
Substance
CETIRIZINE HYDROCHLORIDE
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

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 · 2 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
2019-06-01 22:24 UTC · source 2019-05-30unfinished productproduct58602-446UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip5b2001dcd8f5…54b53d4dc9e4…
2019-06-01 22:24 UTC · source 2019-05-30unfinished packagepackage58602-44658602-446-48UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip5b2001dcd8f5…54b53d4dc9e4…

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 (Hives Relief)
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE5 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1014676Internal RxNorm lookup
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
2b9ac0cd-9dd1-4f78-a16d-9d40f5091c0aAvailable 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
58602-446-09Cetirizine Hydrochloride (Hives Relief)30 in 1 BOTTLETABLET306
58602-446-09Cetirizine Hydrochloride (Hives Relief)1 in 1 CARTONTABLET16
58602-446-17Cetirizine Hydrochloride (Hives Relief)45 in 1 BOTTLETABLET456
58602-446-17Cetirizine Hydrochloride (Hives Relief)1 in 1 CARTONTABLET16
58602-446-21Cetirizine Hydrochloride (Hives Relief)10 in 1 CARTONTABLET106
58602-446-21Cetirizine Hydrochloride (Hives Relief)10 in 1 BLISTER PACKTABLET106
58602-446-41Cetirizine Hydrochloride (Hives Relief)1000 in 1 BOTTLETABLET10006
58602-446-47Cetirizine Hydrochloride (Hives Relief)75 in 1 PACKAGE, COMBINATIONTABLET756

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-446CETIRIZINE HYDROCHLORIDE (HIVES RELIEF) (CETIRIZINE HYDROCHLORIDE) TABLET [AUROHEALTH LLC]6Current NDC, Legacy NDC, 8 package rows20250214_2b9ac0cd-9dd1-4f78-a16d-9d40f5091c0a.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
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
ndc (product): 58602-446
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 TabletPSN2b9ac0cd-9dd1-4f78-a16d-9d40f5091c0a6
1014676cetirizine HCl 5 MG Oral TabletPSN2b9ac0cd-9dd1-4f78-a16d-9d40f5091c0a6
1014678cetirizine hydrochloride 10 MG Oral TabletSCD2b9ac0cd-9dd1-4f78-a16d-9d40f5091c0a6
1014676cetirizine hydrochloride 5 MG Oral TabletSCD2b9ac0cd-9dd1-4f78-a16d-9d40f5091c0a6
1014678cetirizine HCl 10 MG Oral TabletSY2b9ac0cd-9dd1-4f78-a16d-9d40f5091c0a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58602-446-09586020446091 BOTTLE in 1 CARTON (58602-446-09) / 30 TABLET in 1 BOTTLE1 bottle2015-08-050000-00-00NoNoCurrent
58602-446-17586020446171 BOTTLE in 1 CARTON (58602-446-17) / 45 TABLET in 1 BOTTLE1 bottle2015-08-050000-00-00NoNoCurrent
58602-446-215860204462110 BLISTER PACK in 1 CARTON (58602-446-21) / 10 TABLET in 1 BLISTER PACK10 blister pack2015-08-050000-00-00NoNoCurrent
58602-446-41586020446411000 TABLET in 1 BOTTLE (58602-446-41) 1000 tablet2015-08-050000-00-00NoNoCurrent
58602-446-475860204464775 TABLET in 1 PACKAGE, COMBINATION (58602-446-47) 75 tablet2015-08-050000-00-00NoNoCurrent