FDA.reportPublic FDA data

Allergy Relief

Product NDC
72090-059
11-digit product format
720900059
Labeler code
72090
Product ID
72090-059_10617e6f-d985-4db4-b0ba-5890a11070b1
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine HCl
Dosage form
TABLET
Route
ORAL
Labeler
Pioneer Life Sciences, LLC
Application
ANDA209274
Marketing category
ANDA
Marketing start
2020-09-21
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 43.

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.

Product history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-22e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-22cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A209274-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2017-12-22a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Allergy Relief
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
b064f4ba-d5ff-c503-e053-2995a90ab1ecAvailable 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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72090-059-202023-10-25C16284748780-1f386c649-bbd4-0266-e053-dadaa90a7c1aAllergy relief
72090-059-202023-01-30C16284748780-1f386c649-bbd4-0266-e053-dadaa90a7c1aAllergy relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72090-059-20Allergy Relief200 in 1 BOTTLETABLET2004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72090-059ALLERGY RELIEF (CETIRIZINE HCL) TABLET [PIONEER LIFE SCIENCES, LLC]4Current NDC, Legacy NDC, 1 package rows20240522_b064f4ba-d5ff-c503-e053-2995a90ab1ec.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 3 of 3 · 52 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEA-S Medication Solutionsf4da9adf-840d-4526-86a6-6666183fd1072023-07-06WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Allergy ReliefCETIRIZINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFIadcd0e8e-cca7-e1bb-e053-2995a90a83be2023-05-17WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Crcle Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEInnovus Pharmaceuticals, Inc.640583b6-379d-4ad3-b00c-383377c54eed2023-04-21WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Allergy ReliefCETIRIZINE HYDROCHLORIDEWINCO FOODS, LLCf45f5920-d82f-6549-e053-2995a90ad58a2023-04-11WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Allergy ReliefCETIRIZINE HCLCVS PHARMACY, INC34c9e7b3-ccba-4f22-a4d3-20724e7de4862023-02-17WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Allergy ReliefCETIRIZINE HYDROCHLORIDEMARC GLASSMAN, INC.951b6f19-15fe-45d7-e053-2995a90aa2542022-10-06WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Allergy ReliefCETIRIZINE HCLWinCo Foods, LLC39a7d993-805d-4fe8-bc21-3b08e8f78b622022-05-11WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Allergy ReliefCETIRIZINE HYDROCHLORIDEMagno-Humphries, Inc.f0a3e654-5fec-4f98-84da-4c30500633b42021-10-28WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
ALLERGY RELIEFCETIRIZINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.95bf367c-eea8-73f9-e053-2a95a90a3dea2021-07-12WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEStrive Pharmaceuticals Inca4ebeec7-0245-4f77-e053-2995a90a7e7f2020-11-17WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
ALLERGY RELIEFCETIRIZINE HYDROCHLORIDEDISCOUNT DRUG MART844e0e60-f293-4588-9f34-c866bdad6f532020-09-11WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274
Allergy ReliefCETIRIZINE HCL 10 MGAllegiant Healthbef9e980-37b4-430d-8635-3354d578b3b82019-12-12WarningsExact identifier
application applno (ANDA): 209274
application number: ANDA209274

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014678cetirizine HCl 10 MG Oral TabletPSNb064f4ba-d5ff-c503-e053-2995a90ab1ec4
1014678cetirizine hydrochloride 10 MG Oral TabletSCDb064f4ba-d5ff-c503-e053-2995a90ab1ec4
1014678cetirizine HCl 10 MG Oral TabletSYb064f4ba-d5ff-c503-e053-2995a90ab1ec4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72090-059-2072090005920200 TABLET in 1 BOTTLE (72090-059-20) 200 tablet2020-09-210000-00-00NoNoCurrent