FDA.reportPublic FDA data

Cetirizine Hydrochloride

Product NDC
55111-351
11-digit product format
551110351
Labeler code
55111
Product ID
55111-351_000d3a47-3836-b678-9487-2bbc518cd57f
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dr.Reddy's Laboratories Limited
Application
ANDA078343
Marketing category
ANDA
Marketing start
2008-01-15
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
A078343-001CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2008-01-15
A078343-002CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2008-01-15
A078343-003CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2008-01-15
A078343-004CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2008-01-15

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 06:07:402026-07A078343-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2008-01-15caaa826d4ba7…
2026-08-18 06:07:402026-07A078343-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2008-01-15caaa826d4ba7…
2026-08-18 06:07:402026-07A078343-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2008-01-15caaa826d4ba7…
2026-08-18 06:07:402026-07A078343-004CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2008-01-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078343-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2008-01-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078343-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2008-01-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078343-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2008-01-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078343-004CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2008-01-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078343-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2008-01-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078343-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2008-01-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078343-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2008-01-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078343-004CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2008-01-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A078343-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2008-01-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078343-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2008-01-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078343-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2008-01-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078343-004CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2008-01-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078343-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2008-01-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078343-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2008-01-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078343-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2008-01-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078343-004CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2008-01-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078343-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2008-01-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078343-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2008-01-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078343-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2008-01-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078343-004CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2008-01-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078343-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2008-01-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078343-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2008-01-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078343-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2008-01-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078343-004CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2008-01-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078343-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2008-01-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078343-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2008-01-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078343-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2008-01-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078343-004CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2008-01-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078343-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2008-01-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078343-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2008-01-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078343-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2008-01-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078343-004CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2008-01-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078343-001CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2008-01-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078343-002CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2008-01-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078343-003CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2008-01-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078343-004CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2008-01-15d8e5a09893c0…

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
de152651-bfcd-856a-8329-a2ac93a376bcAvailable 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 Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOACETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE ) TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED]5
CETIRIZINEACTIVE MOIETYYO7261ME24CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE ) TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE ) TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE ) TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE ) TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED]5
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE ) TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED]5
POVIDONEINACTIVE INGREDIENTFZ989GH94ECETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE ) TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE ) TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE ) TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-351CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE ) TABLET, FILM COATED [DR.REDDY'S LABORATORIES LIMITED]8Current NDC, Legacy NDC20250321_de152651-bfcd-856a-8329-a2ac93a376bc.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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDE TABLETSPreferred Pharmaceuticals Inc.14a885e5-5e75-4a18-b5bc-6aaa748712db2026-03-25WarningsExact identifier
application applno (ANDA): 078343
application number: ANDA078343
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDE TABLETSProficient Rx LP55b1738c-fa72-4cd1-a8e8-be41b12b593d2026-03-01WarningsExact identifier
application applno (ANDA): 078343
application number: ANDA078343
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDE TABLETSSportpharm LLCd5297bdb-823c-4318-a797-5311d5cf0df82026-02-06WarningsExact identifier
application applno (ANDA): 078343
application number: ANDA078343
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDE TABLETSNorthwind Health Company, LLCf70886af-a8a4-63a0-e053-6294a90a2d2c2026-01-01WarningsExact identifier
application applno (ANDA): 078343
application number: ANDA078343
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDE TABLETSVERITYRX, LLC42778a1c-6894-8646-e063-6294a90a6cb52025-10-31WarningsExact identifier
application applno (ANDA): 078343
application number: ANDA078343
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDE TABLETSBryant Ranch Prepacke4324124-13f8-4450-9fd6-686bd6e255782025-10-28WarningsExact identifier
application applno (ANDA): 078343
application number: ANDA078343
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDE TABLETSDr. Reddy's Laboratories Inc.206ab55a-3720-6205-d710-6e79535714182025-07-17WarningsExact identifier
application applno (ANDA): 078343
application number: ANDA078343
cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDE TABLETSStrategic Sourcing Services LLC52b70885-f623-b1c8-29c6-584bff46ed452025-07-17WarningsExact identifier
application applno (ANDA): 078343
application number: ANDA078343
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEDiscount Drug Mart, Incc7c7e496-3682-c764-88ef-d2a09823f71e2025-07-16WarningsExact identifier
application applno (ANDA): 078343
application number: ANDA078343
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDE TABLETSDr. Reddy's Laboratories Inc.e4eca4df-9ad8-b7c4-b512-bfaed56737892025-07-16WarningsExact identifier
application applno (ANDA): 078343
application number: ANDA078343
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEDr.Reddy's Laboratories Limitedde152651-bfcd-856a-8329-a2ac93a376bc2011-09-30WarningsExact identifier
application applno (ANDA): 078343
application number: ANDA078343
ndc (product): 55111-351

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNde152651-bfcd-856a-8329-a2ac93a376bc8
1014678cetirizine hydrochloride 10 MG Oral TabletSCDde152651-bfcd-856a-8329-a2ac93a376bc8
1014678cetirizine HCl 10 MG Oral TabletSYde152651-bfcd-856a-8329-a2ac93a376bc8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-351-04551110351041 BOTTLE in 1 CARTON (55111-351-04) / 120 TABLET, FILM COATED in 1 BOTTLE1 bottle2008-01-150000-00-00NoNoCurrent
55111-351-30551110351301 BOTTLE in 1 CARTON (55111-351-30) / 30 TABLET, FILM COATED in 1 BOTTLE1 bottle2008-01-150000-00-00NoNoCurrent
55111-351-45551110351451 BOTTLE in 1 CARTON (55111-351-45) / 45 TABLET, FILM COATED in 1 BOTTLE1 bottle2008-01-150000-00-00NoNoCurrent
55111-351-47551110351472 BOTTLE in 1 CARTON (55111-351-47) / 175 TABLET, FILM COATED in 1 BOTTLE2 bottle2008-01-150000-00-00NoNoCurrent
55111-351-51551110351511 BOTTLE in 1 CARTON (55111-351-51) / 75 TABLET, FILM COATED in 1 BOTTLE1 bottle2008-01-150000-00-00NoNoCurrent
55111-351-60551110351601 BOTTLE in 1 CARTON (55111-351-60) / 60 TABLET, FILM COATED in 1 BOTTLE1 bottle2008-01-150000-00-00NoNoCurrent
55111-351-74551110351742 BLISTER PACK in 1 CARTON (55111-351-74) / 7 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2008-01-150000-00-00NoNoCurrent
55111-351-90551110351901 BOTTLE in 1 CARTON (55111-351-90) / 90 TABLET, FILM COATED in 1 BOTTLE1 bottle2008-01-150000-00-00NoNoCurrent