FDA.reportPublic FDA data

CETIRIZINE HYDROCHLORIDE

Product NDC
55681-073
Requested package NDC
55681-073-03
11-digit product format
556810073
Labeler code
55681
Product ID
55681-073_4e69476d-dee2-dac7-e063-6294a90a06d4
Type
HUMAN OTC DRUG
Nonproprietary name
CETIRIZINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
TWIN MED, LLC
Application
ANDA209274
Marketing category
ANDA
Marketing start
2022-03-02
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209274-001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2017-12-22

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-22a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 3 · 56 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetirizine hydrochloride - HIVESCETIRIZINE HYDROCHLORIDEGranules Pharmaceuticals Inc.562b5e6c-6103-df3d-e063-6394a90a897d2026-07-14WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEGranules India Ltd6efd5a60-e281-43f9-a52c-a95f46fbcbfc2026-07-14WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
MedlineCETIRIZINE HCLMedline Industries, LPa75cd557-e19b-fdd4-e053-2a95a90a80972026-06-04WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Allergy ReliefCETIRIZINE HYDROCHLORIDEAAA PHARMACEUTICAL, INC.ac22558b-5c82-4ab9-95b8-53eedea462822026-05-28WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Allergy ReliefCETIRIZINE HYDROCHLORIDEGrocery Outlet, Inc441d049c-8844-955e-e063-6294a90a666d2026-05-21WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDETWIN MED, LLC14317ee7-1061-4c2b-9427-3433e27f13f52026-04-01WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
ndc (package): 55681-073-03
ndc (product): 55681-073
ndc11 (package): 55681007303
Allergy ReliefCETIRIZINE HCLBryant Ranch Prepack7e4a2d02-c2b3-4a1f-8373-a0b0dec5ddea2026-03-10WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
All Day Allergy ReliefCETIRIZINE HCLP & L Development, LLCc5dab2f3-8f95-4b85-995b-23b21c762ae82026-02-23WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
All Day Allergy ReliefCETIRIZINE HCLStrategic Sourcing Services LLC2965303e-bedc-41fb-af97-827c305750912026-01-05WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEGranules USA, Inc.c8d711cd-7214-c7d5-e053-2995a90a6b672025-12-22WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDERETAIL BUSINESS SERVICES,LLC.9f04520e-161d-3f7b-e053-2a95a90a678d2025-12-19WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Cetirizine HCLCETIRIZINE HCLMeijer181c63dd-6ab8-909a-e063-6394a90af1412025-12-19WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
CetirizineCETIIRIZINECVS PHARMACY, INCfd8f495a-9940-363b-e053-6294a90a10972025-12-19WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDESAFEWAYed0eecfb-85bf-63bf-e053-2995a90a0e032025-12-18WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Allergy ReliefCETIRIZINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYdc66bf53-820f-40a3-b5ef-c653dd3755442025-12-11WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEGranules Pharmaceuticals Inc.d55dfce1-acef-3342-e053-2a95a90a4b832025-12-04WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
CAREALL Allergy ReliefCETIRIZINE HCLNew World Importsd3411eec-05b1-49b3-86e8-bc47ac0ef6b72025-12-01WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Allergy ReliefCETIRIZINE HCLFamily Dollar (FAMILY WELLNESS)b90b5ef2-5aa2-45ca-94b9-c9d9e5877e232025-09-25WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Wal-ZyrCETIRIZINE HCLWalgreensf0d3f681-92c4-45d4-9533-656c9e5e23662025-07-02WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEAdvanced Rx LLC737492bf-96bd-4f7c-aa42-4910746f44bb2025-05-13WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274

Additional Listing Data#

Finished product
Yes
Brand name base
CETIRIZINE HYDROCHLORIDE
Listing expiration
2027-12-31

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
14317ee7-1061-4c2b-9427-3433e27f13f5Available 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
55681-073-03CETIRIZINE HYDROCHLORIDE300 in 1 BOTTLETABLET3001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSN14317ee7-1061-4c2b-9427-3433e27f13f51
1014678cetirizine hydrochloride 10 MG Oral TabletSCD14317ee7-1061-4c2b-9427-3433e27f13f51
1014678cetirizine HCl 10 MG Oral TabletSY14317ee7-1061-4c2b-9427-3433e27f13f51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55681-073-0355681007303300 TABLET in 1 BOTTLE (55681-073-03) 300 tablet2026-04-01NoNoCurrent