FDA.reportPublic FDA data

Cetirizine Hydrochloride

Product NDC
71335-0300
11-digit product format
713350300
Labeler code
71335
Product ID
71335-0300_80b8a53e-8bc2-4bd7-b002-a7736af37618
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077829
Marketing category
ANDA
Marketing start
2009-10-01
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 42.

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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077829-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2009-08-26caaa826d4ba7…
2026-08-18 06:07:402026-07A077829-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORALRS2009-08-26caaa826d4ba7…
2026-08-18 06:07:402026-07A077829-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2009-08-26caaa826d4ba7…
2026-08-18 06:07:402026-07A077829-004CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2009-08-26caaa826d4ba7…
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…

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
4b192084-dfdc-47bc-a968-6f49e137b248Available 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
71335-0300-1Cetirizine Hydrochloride30 in 1 BOTTLETABLET309
71335-0300-2Cetirizine Hydrochloride14 in 1 BOTTLETABLET149
71335-0300-3Cetirizine Hydrochloride7 in 1 BOTTLETABLET79
71335-0300-4Cetirizine Hydrochloride10 in 1 BOTTLETABLET109
71335-0300-5Cetirizine Hydrochloride15 in 1 BOTTLETABLET159
71335-0300-6Cetirizine Hydrochloride90 in 1 BOTTLETABLET909
71335-0300-7Cetirizine Hydrochloride20 in 1 BOTTLETABLET209
71335-0300-8Cetirizine Hydrochloride60 in 1 BOTTLETABLET609
71335-0300-9Cetirizine Hydrochloride100 in 1 BOTTLETABLET1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0300-1EA - Each71335-0300e20488a2-34f2-42a1-9464-785c88d7188712018-04-19
71335-0300-2EA - Each71335-03001e1d2893-c766-4168-9b20-a69ce74ba67f12018-04-19
71335-0300-6EA - Each71335-030020ca9a0b-511e-439b-a5da-2460e49d5af212018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0300CETIRIZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]9Current NDC, Legacy NDC, 9 package rows20240726_4b192084-dfdc-47bc-a968-6f49e137b248.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 HYDROCHLORIDENuCare Pharmaceuticals, Inc.4913192a-7364-3f19-e054-00144ff8d46c2026-08-20WarningsExact identifier
application applno (ANDA): 077829
application number: ANDA077829
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
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEUmasuto, LLC9af4ab23-d6d3-43f9-a026-76fd9771963f2025-03-06WarningsExact identifier
application applno (ANDA): 077829
application number: ANDA077829

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN4b192084-dfdc-47bc-a968-6f49e137b2489
1014678cetirizine hydrochloride 10 MG Oral TabletSCD4b192084-dfdc-47bc-a968-6f49e137b2489
1014678cetirizine HCl 10 MG Oral TabletSY4b192084-dfdc-47bc-a968-6f49e137b2489

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0300-17133503000130 TABLET in 1 BOTTLE (71335-0300-1) 30 tablet2018-02-160000-00-00NoNoCurrent
71335-0300-27133503000214 TABLET in 1 BOTTLE (71335-0300-2) 14 tablet2018-02-200000-00-00NoNoCurrent
71335-0300-3713350300037 TABLET in 1 BOTTLE (71335-0300-3) 7 tablet2022-02-090000-00-00NoNoCurrent
71335-0300-47133503000410 TABLET in 1 BOTTLE (71335-0300-4) 10 tablet2019-03-190000-00-00NoNoCurrent
71335-0300-57133503000515 TABLET in 1 BOTTLE (71335-0300-5) 15 tablet2022-02-090000-00-00NoNoCurrent
71335-0300-67133503000690 TABLET in 1 BOTTLE (71335-0300-6) 90 tablet2018-02-160000-00-00NoNoCurrent
71335-0300-77133503000720 TABLET in 1 BOTTLE (71335-0300-7) 20 tablet2019-03-070000-00-00NoNoCurrent
71335-0300-87133503000860 TABLET in 1 BOTTLE (71335-0300-8) 60 tablet2021-10-130000-00-00NoNoCurrent
71335-0300-971335030009100 TABLET in 1 BOTTLE (71335-0300-9) 100 tablet2019-05-030000-00-00NoNoCurrent