FDA.reportPublic FDA data

Cetirizine Hydrochloride (Allergy)

Product NDC
0363-0068
11-digit product format
003630068
Labeler code
0363
Product ID
0363-0068_5d00aeb2-1ed9-4d51-a939-e137af4608f2
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
WALGREEN CO.
Application
ANDA209107
Marketing category
ANDA
Marketing start
2020-06-08
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 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209107-001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGCAPSULE / ORAL2018-07-20
A209107-002CETIRIZINE HYDROCHLORIDE HIVES RELIEFCETIRIZINE HYDROCHLORIDE10MGCAPSULE / ORAL2018-07-20

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 22:54:322026-06A209107-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2018-07-20a50c72e98297…
2026-08-01 22:54:322026-06A209107-002CETIRIZINE HYDROCHLORIDE HIVES RELIEF10MGCAPSULE / ORAL2018-07-20a50c72e98297…

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 1 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEAurohealth LLCffbca2a4-8df0-4c85-adf9-9414cd706fb22026-02-26WarningsExact identifier
application applno (ANDA): 209107
application number: ANDA209107
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEWALGREEN CO.3d2eac7f-db44-4771-8c7e-a38e68a7f24b2025-04-05WarningsExact identifier
application applno (ANDA): 209107
application number: ANDA209107
ndc (product): 0363-0068
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEBetter Living Brands, LLCf7deb8ca-4a26-aece-e053-6294a90aa6852023-11-22WarningsExact identifier
application applno (ANDA): 209107
application number: ANDA209107
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEAurohealth LLC1bbefda2-d3c5-4d31-b3ec-7da077e411572022-08-16WarningsExact identifier
application applno (ANDA): 209107
application number: ANDA209107
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDERITE AID CORPORATIONde169567-5cde-5c4a-e053-2a95a90a12152022-07-21WarningsExact identifier
application applno (ANDA): 209107
application number: ANDA209107
Cetirizine Hydrochloride (Allergy)CETIRIZINE HYDROCHLORIDEAurohealth LLC0b6e8c63-a76c-4184-a9cc-9691378c3ee52021-03-11WarningsExact identifier
application applno (ANDA): 209107
application number: ANDA209107
Cetirizine Hydrochloride (Hives Relief)CETIRIZINE HYDROCHLORIDEAurohealth LLCf0f486e1-2eeb-4eaa-b557-908bcbf973a82020-09-14WarningsExact identifier
application applno (ANDA): 209107
application number: ANDA209107

Additional Listing Data#

Finished product
Yes
Brand name base
Cetirizine Hydrochloride (Allergy)
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
1014675Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3d2eac7f-db44-4771-8c7e-a38e68a7f24bAvailable 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
0363-0068-12Cetirizine Hydrochloride (Allergy)1 in 1 CARTONCAPSULE15
0363-0068-12Cetirizine Hydrochloride (Allergy)40 in 1 BOTTLECAPSULE405
0363-0068-53Cetirizine Hydrochloride (Allergy)1 in 1 CARTONCAPSULE15
0363-0068-53Cetirizine Hydrochloride (Allergy)25 in 1 BOTTLECAPSULE255

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0068CETIRIZINE HYDROCHLORIDE (ALLERGY) (CETIRIZINE HYDROCHLORIDE) CAPSULE [WALGREEN CO.]5Current NDC, Legacy NDC, 4 package rows20250410_3d2eac7f-db44-4771-8c7e-a38e68a7f24b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014675cetirizine HCl 10 MG 24HR Oral CapsulePSN3d2eac7f-db44-4771-8c7e-a38e68a7f24b5
1014675cetirizine hydrochloride 10 MG Oral CapsuleSCD3d2eac7f-db44-4771-8c7e-a38e68a7f24b5
1014675cetirizine HCl 10 MG 24 HR Oral CapsuleSY3d2eac7f-db44-4771-8c7e-a38e68a7f24b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0068-12003630068121 BOTTLE in 1 CARTON (0363-0068-12) / 40 CAPSULE in 1 BOTTLE1 bottle2020-06-080000-00-00NoNoCurrent
0363-0068-53003630068531 BOTTLE in 1 CARTON (0363-0068-53) / 25 CAPSULE in 1 BOTTLE1 bottle2020-06-080000-00-00NoNoCurrent