FDA.reportPublic FDA data

Cetirizine Hydrochloride

Product NDC
63629-4914
11-digit product format
636294914
Labeler code
63629
Product ID
63629-4914_3db925ae-d07d-4da4-9dab-155db44d75a0
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
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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage63629-4914-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage63629-4914-11332a3947898…d4bfe170f9cd…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage63629-4914-18dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage63629-4914-1e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-4914-19bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage63629-4914-1110d247fa046…a55b01930146…

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 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1014676Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ddec7d64-ab3d-4ddd-9bcd-b7f4d2b46be7Available 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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-05-24Cetirizine Hydrochloride Tablets USP 5 mg, Allergy
2024-01-30Cetirizine Hydrochloride Tablets USP 5 mg, Allergy
2022-02-16Cetirizine Hydrochloride Tablets USP 5 mg, Allergy
2019-11-27Cetirizine Hydrochloride Tablets USP 5 mg, Allergy

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-4914-1Cetirizine Hydrochloride30 in 1 BOTTLETABLET301003

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOACETIRIZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
CETIRIZINEACTIVE MOIETYYO7261ME24CETIRIZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCETIRIZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GCETIRIZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CETIRIZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACETIRIZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
POVIDONESINACTIVE INGREDIENTFZ989GH94ECETIRIZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCETIRIZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCETIRIZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-4914CETIRIZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1003Current NDC, Legacy NDC, 1 package rows20240524_ddec7d64-ab3d-4ddd-9bcd-b7f4d2b46be7.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
1014676cetirizine HCl 5 MG Oral TabletPSNddec7d64-ab3d-4ddd-9bcd-b7f4d2b46be71003
1014676cetirizine hydrochloride 5 MG Oral TabletSCDddec7d64-ab3d-4ddd-9bcd-b7f4d2b46be71003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-4914-16362949140130 TABLET in 1 BOTTLE (63629-4914-1) 30 tablet2013-02-190000-00-00NoNoCurrent