FDA.reportPublic FDA data

Allergy Relief

Product NDC
72090-028
11-digit product format
720900028
Labeler code
72090
Product ID
72090-028_020923b5-3a55-4a8a-bd07-2c650368f8ec
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine HCl
Dosage form
TABLET
Route
ORAL
Labeler
Pioneer Life Sciences, LLC
Application
ANDA077829
Marketing category
ANDA
Marketing start
2023-10-26
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
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
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
205b42e0-9d02-4755-9ee6-5883147abeb3Available 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
72090-028-20Allergy Relief200 in 1 BOTTLETABLET2003
72090-028-01Allergy Relief300 in 1 BOTTLETABLET3002
72090-028-03ALLERGY RELIEF10000 in 1 DRUMTABLET100001
72090-028-04Allergy Relief500 in 1 BOTTLETABLET5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72090-028ALLERGY RELIEF (CETIRIZINE HCL) TABLET [PIONEER LIFE SCIENCES, LLC]2Current NDC, 1 package rows20240522_205b42e0-9d02-4755-9ee6-5883147abeb3.zip
72090-028ALLERGY RELIEF (CETIRIZINE HCL) TABLET [PIONEER LIFE SCIENCES, LLC]1Current NDC, 1 package rows20241006_b275feae-56a1-4a60-a564-8d7b18c06aa2.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
ndc (product): 72090-028
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
ndc (product): 72090-028
Allergy ReliefCETIRIZINE HCLPioneer Life Sciences, LLCb275feae-56a1-4a60-a564-8d7b18c06aa22025-12-23WarningsExact identifier
application applno (ANDA): 077829
application number: ANDA077829
ndc (product): 72090-028
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
ndc (product): 72090-028
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
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 TabletPSN205b42e0-9d02-4755-9ee6-5883147abeb33
1014678cetirizine hydrochloride 10 MG Oral TabletSCD205b42e0-9d02-4755-9ee6-5883147abeb33
1014678cetirizine HCl 10 MG Oral TabletSY205b42e0-9d02-4755-9ee6-5883147abeb33
1014678cetirizine HCl 10 MG Oral TabletPSNb275feae-56a1-4a60-a564-8d7b18c06aa22
1014678cetirizine hydrochloride 10 MG Oral TabletSCDb275feae-56a1-4a60-a564-8d7b18c06aa22
1014678cetirizine HCl 10 MG Oral TabletSYb275feae-56a1-4a60-a564-8d7b18c06aa22
1014678cetirizine HCl 10 MG Oral TabletPSN110adf3c-84ce-48a1-8a22-89ee3eec22d91
1014678cetirizine HCl 10 MG Oral TabletPSN5249b83c-30d4-4b5b-aeb1-f52418ba079f1
1014678cetirizine hydrochloride 10 MG Oral TabletSCD110adf3c-84ce-48a1-8a22-89ee3eec22d91
1014678cetirizine hydrochloride 10 MG Oral TabletSCD5249b83c-30d4-4b5b-aeb1-f52418ba079f1
1014678cetirizine HCl 10 MG Oral TabletSY110adf3c-84ce-48a1-8a22-89ee3eec22d91
1014678cetirizine HCl 10 MG Oral TabletSY5249b83c-30d4-4b5b-aeb1-f52418ba079f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72090-028-0172090002801300 TABLET in 1 BOTTLE (72090-028-01) 300 tablet2024-10-03NoNoCurrent
72090-028-037209000280310000 TABLET in 1 DRUM (72090-028-03) 10000 tablet2025-06-01NoNoCurrent
72090-028-0472090002804500 TABLET in 1 BOTTLE (72090-028-04) 500 tablet2026-04-06NoNoCurrent
72090-028-2072090002820200 TABLET in 1 BOTTLE (72090-028-20) 200 tablet2023-10-26NoNoCurrent