Cetirizine Hydrochloride

Product NDC
47335-344
Requested package NDC
47335-344-16
11-digit product format
473350344
Labeler code
47335
Product ID
47335-344_650b77fc-76c9-4ab9-a671-d72f6def4c42
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA090142
Marketing category
ANDA
Marketing start
2011-09-09
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
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage47335-34447335-344-16DDiscontinued by firm2026-08-03

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 · 9 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…

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
A090142-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MGTABLET, CHEWABLE / ORAL2011-08-30
A090142-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGTABLET, CHEWABLE / ORAL2011-08-30
A090142-003CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEFCETIRIZINE HYDROCHLORIDE5MGTABLET, CHEWABLE / ORAL2011-08-30
A090142-004CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEFCETIRIZINE HYDROCHLORIDE10MGTABLET, CHEWABLE / ORAL2011-08-30

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 UTC2026-02A090142-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET, CHEWABLE / ORAL2011-08-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090142-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET, CHEWABLE / ORAL2011-08-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090142-003CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET, CHEWABLE / ORAL2011-08-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090142-004CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET, CHEWABLE / ORAL2011-08-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090142-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET, CHEWABLE / ORAL2011-08-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090142-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET, CHEWABLE / ORAL2011-08-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090142-003CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET, CHEWABLE / ORAL2011-08-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090142-004CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET, CHEWABLE / ORAL2011-08-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A090142-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET, CHEWABLE / ORAL2011-08-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090142-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET, CHEWABLE / ORAL2011-08-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090142-003CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET, CHEWABLE / ORAL2011-08-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090142-004CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET, CHEWABLE / ORAL2011-08-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090142-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET, CHEWABLE / ORAL2011-08-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090142-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET, CHEWABLE / ORAL2011-08-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090142-003CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET, CHEWABLE / ORAL2011-08-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090142-004CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET, CHEWABLE / ORAL2011-08-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090142-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET, CHEWABLE / ORAL2011-08-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090142-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET, CHEWABLE / ORAL2011-08-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090142-003CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET, CHEWABLE / ORAL2011-08-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090142-004CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET, CHEWABLE / ORAL2011-08-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090142-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET, CHEWABLE / ORAL2011-08-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090142-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET, CHEWABLE / ORAL2011-08-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090142-003CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET, CHEWABLE / ORAL2011-08-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090142-004CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET, CHEWABLE / ORAL2011-08-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090142-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET, CHEWABLE / ORAL2011-08-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090142-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET, CHEWABLE / ORAL2011-08-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090142-003CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET, CHEWABLE / ORAL2011-08-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090142-004CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET, CHEWABLE / ORAL2011-08-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090142-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET, CHEWABLE / ORAL2011-08-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090142-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET, CHEWABLE / ORAL2011-08-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090142-003CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET, CHEWABLE / ORAL2011-08-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090142-004CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET, CHEWABLE / ORAL2011-08-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090142-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET, CHEWABLE / ORAL2011-08-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090142-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET, CHEWABLE / ORAL2011-08-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090142-003CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET, CHEWABLE / ORAL2011-08-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090142-004CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET, CHEWABLE / ORAL2011-08-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090142-001CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET, CHEWABLE / ORAL2011-08-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A090142-002CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET, CHEWABLE / ORAL2011-08-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A090142-003CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MGTABLET, CHEWABLE / ORAL2011-08-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A090142-004CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGTABLET, CHEWABLE / ORAL2011-08-30d06236e962d9…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47335-344-83Cetirizine Hydrochloride30 in 1 BOTTLETABLET, CHEWABLE3012
47335-344-88Cetirizine Hydrochloride100 in 1 BOTTLETABLET, CHEWABLE10012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47335-344-83EA - Each47335-3442f6a2325-3993-475b-ac3a-8bd9cdfb34b712013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOACETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]5
CETIRIZINEACTIVE MOIETYYO7261ME24CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]5
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]5
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]5
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]5
GUAR GUMINACTIVE INGREDIENTE89I1637KECETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]5
MAGNESIUM OXIDEINACTIVE INGREDIENT3A3U0GI71GCETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]5
MANNITOLINACTIVE INGREDIENT3OWL53L36ACETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]5
SUCROSEINACTIVE INGREDIENTC151H8M554CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]5
TALCINACTIVE INGREDIENT7SEV7J4R1UCETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]5
CETIRIZINE HYDROCHLORIDEACTIVE INGREDIENT64O047KTOACETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]1
CETIRIZINEACTIVE MOIETYYO7261ME24CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]1
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]1
GUAR GUMINACTIVE INGREDIENTE89I1637KECETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]1
MAGNESIUM OXIDEINACTIVE INGREDIENT3A3U0GI71GCETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ACETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]1
SUCROSEINACTIVE INGREDIENTC151H8M554CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]1
TALCINACTIVE INGREDIENT7SEV7J4R1UCETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMA GLOBAL FZE]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-344CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SUN PHARMACEUTICAL INDUSTRIES, INC.]11Current NDC, Legacy NDC, 2 package rows20240920_a4758152-97dd-4a27-b4d9-11178654b93e.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEOHM LABORATORIES INC.97802669-b4bd-4807-b3c1-6c6f5a2b0c672026-06-03WarningsExact identifier
application applno (ANDA): 090142
application number: ANDA090142

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014674cetirizine HCl 10 MG Chewable TabletPSNa4758152-97dd-4a27-b4d9-11178654b93e12
1014643cetirizine HCl 5 MG Chewable TabletPSNa4758152-97dd-4a27-b4d9-11178654b93e12
1014674cetirizine hydrochloride 10 MG Chewable TabletSCDa4758152-97dd-4a27-b4d9-11178654b93e12
1014643cetirizine hydrochloride 5 MG Chewable TabletSCDa4758152-97dd-4a27-b4d9-11178654b93e12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
47335-344-1647335034416100 TABLET, CHEWABLE in 1 BOTTLE (47335-344-16) 2011-09-260000-00-00NoNoCurrent