FDA.reportPublic FDA data

Cabinet All Day Allergy Relief

Product NDC
82725-3103
11-digit product format
827253103
Labeler code
82725
Product ID
82725-3103_3231f007-8ce6-a79f-e063-6394a90a4af4
Type
HUMAN OTC DRUG
Nonproprietary name
CETIRIZINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Cabinet Health P.B.C.
Application
ANDA077829
Marketing category
ANDA
Marketing start
2025-03-21
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
A077829-001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2009-08-26
A077829-002CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDE10MGTABLET / ORALRS2009-08-26
A077829-003CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2009-08-26
A077829-004CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2009-08-26

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 UTC2026-02A077829-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-08-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077829-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORALRS2009-08-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077829-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-08-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077829-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-08-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077829-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-08-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077829-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORALRS2009-08-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077829-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-08-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077829-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-08-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A077829-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-08-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077829-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORALRS2009-08-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077829-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-08-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077829-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-08-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077829-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-08-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077829-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORALRS2009-08-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077829-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-08-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077829-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-08-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077829-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-08-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077829-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORALRS2009-08-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077829-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-08-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077829-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-08-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077829-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-08-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077829-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORALRS2009-08-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077829-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-08-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077829-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-08-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077829-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-08-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077829-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORALRS2009-08-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077829-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-08-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077829-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-08-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077829-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-08-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077829-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORALRS2009-08-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077829-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-08-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077829-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-08-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077829-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-08-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077829-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORALRS2009-08-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077829-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-08-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077829-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-08-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077829-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-08-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A077829-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORALRS2009-08-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A077829-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-08-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A077829-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-08-26d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
Cabinet All Day Allergy Relief
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
889316bc-5f98-426a-9750-2fdb0c427408Available 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
82725-3103-3Cabinet All Day Allergy Relief300 in 1 BOTTLETABLET3001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82725-3103CABINET ALL DAY ALLERGY RELIEF (CETIRIZINE HYDROCHLORIDE) TABLET [CABINET HEALTH P.B.C.]1Current NDC, 1 package rows20250410_889316bc-5f98-426a-9750-2fdb0c427408.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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDESt. Mary's Medical Park Pharmacyf2f42f36-6b09-4140-e053-2a95a90af8132026-06-29WarningsExact identifier
application applno (ANDA): 077829
application number: ANDA077829
Goodmeds All Day Allergy Relief Cetirizine HClCETIRIZINE HYDROCHLORIDECabinet Health P.B.C.cd13a70e-b9e2-41be-97ea-f022442b64602026-04-08WarningsExact identifier
application applno (ANDA): 077829
application number: ANDA077829
Allergy ReliefCETIRIZINE HCLPioneer Life Sciences, LLC5249b83c-30d4-4b5b-aeb1-f52418ba079f2026-04-06WarningsExact identifier
application applno (ANDA): 077829
application number: ANDA077829
Indoor and Outdoor Allergy ReliefCETIRIZINE HCLFamora Inc.2a94d25c-aacf-4f5c-b406-815f0e1d06112026-03-18WarningsExact identifier
application applno (ANDA): 077829
application number: ANDA077829
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDESportpharm LLCdd50d2e9-3de7-4c44-96ed-39ef04dae7022026-02-06WarningsExact identifier
application applno (ANDA): 077829
application number: ANDA077829
Allergy ReliefCETIRIZINE HYDROCHLORIDEStrategic Sourcing Services LLC54509525-ad99-4165-a571-47ece058e2922026-01-29WarningsExact identifier
application applno (ANDA): 077829
application number: ANDA077829
Allergy ReliefCETIRIZINE HYDROCHLORIDEProdose, Ince0e5f482-0282-410c-8c40-0a33ca4ea23a2026-01-26WarningsExact identifier
application applno (ANDA): 077829
application number: ANDA077829
Allergy ReliefCETIRIZINE HCLPioneer Life Sciences, LLC205b42e0-9d02-4755-9ee6-5883147abeb32025-12-23WarningsExact identifier
application applno (ANDA): 077829
application number: ANDA077829
Allergy ReliefCETIRIZINE HCLPioneer Life Sciences, LLCb275feae-56a1-4a60-a564-8d7b18c06aa22025-12-23WarningsExact identifier
application applno (ANDA): 077829
application number: ANDA077829
Allergy ReliefCETIRIZINE HCLNUVICARE LLCc728edf3-e6b5-4860-b966-39cf3ee4ff772025-12-19WarningsExact identifier
application applno (ANDA): 077829
application number: ANDA077829
RIGHT REMEDIES ALL-DAY Allergy ReliefCETIRIZINE HYDROCHLORIDEStrive Pharmaceuticals Inc.8227edbe-88d5-4d79-9175-891dd95663572025-11-20WarningsExact identifier
application applno (ANDA): 077829
application number: ANDA077829
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDERising Pharma Holdings, Inc.5481ccb3-b311-4b25-b923-4fe8522ea92b2025-11-05WarningsExact identifier
application applno (ANDA): 077829
application number: ANDA077829
ValuMeds All Day Allergy Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDECabinet Health P.B.C.3071238a-6b35-4da8-8305-eced56c513ce2025-10-23WarningsExact identifier
application applno (ANDA): 077829
application number: ANDA077829
CVS Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDECVS Pharmacy3d711302-dc4e-0a69-e063-6394a90ade102025-09-18WarningsExact identifier
application applno (ANDA): 077829
application number: ANDA077829
Cabinet Allergy Relief Refill Cetirizine HCICETIRIZINE HYDROCHLORIDECabinet Health P.B.C.0eaf9d27-e221-4cdd-97bc-478c775e3d672025-07-03WarningsExact identifier
application applno (ANDA): 077829
application number: ANDA077829
Allergy ReliefCETIRIZINE HCLNUVICARE LLC09dfdce2-7184-4247-983c-a5667e4a9da12025-06-09WarningsExact identifier
application applno (ANDA): 077829
application number: ANDA077829
ALLERGY RELIEFCETIRIZINE HCLPioneer Life Sciences, LLC110adf3c-84ce-48a1-8a22-89ee3eec22d92025-06-01WarningsExact identifier
application applno (ANDA): 077829
application number: ANDA077829
Cabinet All Day Allergy ReliefCETIRIZINE HYDROCHLORIDECabinet Health P.B.C.889316bc-5f98-426a-9750-2fdb0c4274082025-04-07WarningsExact identifier
application applno (ANDA): 077829
application number: ANDA077829
ndc (product): 82725-3103
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEUmasuto, LLC9af4ab23-d6d3-43f9-a026-76fd9771963f2025-03-06WarningsExact identifier
application applno (ANDA): 077829
application number: ANDA077829
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEBryant Ranch Prepack4b192084-dfdc-47bc-a968-6f49e137b2482024-07-25WarningsExact identifier
application applno (ANDA): 077829
application number: ANDA077829

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN889316bc-5f98-426a-9750-2fdb0c4274081
1014678cetirizine hydrochloride 10 MG Oral TabletSCD889316bc-5f98-426a-9750-2fdb0c4274081
1014678cetirizine HCl 10 MG Oral TabletSY889316bc-5f98-426a-9750-2fdb0c4274081

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82725-3103-382725310303300 TABLET in 1 BOTTLE (82725-3103-3) 300 tablet2025-03-21NoNoCurrent