FDA.reportPublic FDA data

ZYRTEC Allergy

Product NDC
50580-786
11-digit product format
505800786
Labeler code
50580
Product ID
50580-786_41a5a9a1-61a6-f771-e063-6294a90aed87
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Kenvue Brands LLC
Application
ANDA213105
Marketing category
ANDA
Marketing start
2024-04-15
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 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
A213105-001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGCAPSULE / ORAL2020-09-21

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
2026-02-19 14:30 UTC2026-02A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-214b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213105-001CETIRIZINE HYDROCHLORIDE ALLERGY10MGCAPSULE / ORAL2020-09-21a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
ZYRTEC 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1014675Internal RxNorm lookup
1020023Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0face45c-af24-3559-e063-6294a90abde5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-786-12ZYRTEC Allergy12 in 1 BOTTLECAPSULE, LIQUID FILLED126
50580-786-12ZYRTEC Allergy1 in 1 PACKAGECAPSULE, LIQUID FILLED16
50580-786-13ZYRTEC Allergy12 in 1 BOTTLECAPSULE, LIQUID FILLED126
50580-786-13ZYRTEC Allergy1 in 1 CARTONCAPSULE, LIQUID FILLED16
50580-786-25ZYRTEC Allergy1 in 1 PACKAGECAPSULE, LIQUID FILLED16
50580-786-25ZYRTEC Allergy25 in 1 BOTTLECAPSULE, LIQUID FILLED256
50580-786-26ZYRTEC Allergy25 in 1 BOTTLECAPSULE, LIQUID FILLED256
50580-786-26ZYRTEC Allergy1 in 1 CARTONCAPSULE, LIQUID FILLED16
50580-786-40ZYRTEC Allergy40 in 1 BOTTLECAPSULE, LIQUID FILLED406
50580-786-40ZYRTEC Allergy1 in 1 PACKAGECAPSULE, LIQUID FILLED16
50580-786-41ZYRTEC Allergy40 in 1 BOTTLECAPSULE, LIQUID FILLED406
50580-786-41ZYRTEC Allergy1 in 1 CARTONCAPSULE, LIQUID FILLED16
50580-786-65ZYRTEC Allergy65 in 1 PACKAGE, COMBINATIONCAPSULE, LIQUID FILLED656
50580-786-66ZYRTEC Allergy65 in 1 PACKAGECAPSULE, LIQUID FILLED656

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-786ZYRTEC ALLERGY (CETIRIZINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [KENVUE BRANDS LLC]4Current NDC, 14 package rows20250323_0face45c-af24-3559-e063-6294a90abde5.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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy ReliefCETIRIZINE HCLWALMART INC. (see also Equate)967be504-85b1-4e9b-9b08-2b27a43fa0aa2026-06-18WarningsExact identifier
application applno (ANDA): 213105
application number: ANDA213105
Allergy ReliefCETIRIZINE HCLCVS PHARMACY, INCfb850a4c-7ac1-4993-b6ea-5c8d42e177032026-05-18WarningsExact identifier
application applno (ANDA): 213105
application number: ANDA213105
All Day AllergyCETIRIZINE HCLWALMART INC. (see also Equate)c8016d34-aa72-4857-b5ed-5476948b386a2026-02-20WarningsExact identifier
application applno (ANDA): 213105
application number: ANDA213105
Allergy ReliefCETIRIZINE HCLSafeway, Inc.1fbb274c-cacc-4ba9-be97-33d83e2773db2025-12-16WarningsExact identifier
application applno (ANDA): 213105
application number: ANDA213105
ZYRTEC AllergyCETIRIZINE HYDROCHLORIDEKenvue Brands LLC0face45c-af24-3559-e063-6294a90abde52025-10-21WarningsExact identifier
application applno (ANDA): 213105
application number: ANDA213105
ndc (product): 50580-786
All Day Allergy ReliefCETIRIZINE HCLP & L Development, LLC7dabf6bd-8a96-4e7f-bc19-5a47cec364192025-05-16WarningsExact identifier
application applno (ANDA): 213105
application number: ANDA213105
basic care all day allergyCETIRIZINE HYDROCHLORIDEAmazon.com Services LLCe71e259a-494e-4a9a-b0e4-25bd25dd0e072025-04-06WarningsExact identifier
application applno (ANDA): 213105
application number: ANDA213105
Allergy ReliefCETIRIZINE HCLH E B4bbf0be5-7bcc-46c6-a443-7b37d4679c6f2024-05-10WarningsExact identifier
application applno (ANDA): 213105
application number: ANDA213105
topcare all day allergyCETIRIZINE HYDROCHLORIDETopco Associates LLC10c512a1-bb96-4d2a-9e41-a422efb57e282023-02-09WarningsExact identifier
application applno (ANDA): 213105
application number: ANDA213105
Allergy ReliefCETIRIZINE HCLPublix Supermarkets, Inc.cb70ca8b-847f-4122-b86f-bf5d39e2a83b2022-11-08WarningsExact identifier
application applno (ANDA): 213105
application number: ANDA213105
Allergy ReliefCETIRIZINE HCLCVS PHARMACY, INCed8951a1-bd7e-439d-a427-685d56a9c9ad2022-11-07WarningsExact identifier
application applno (ANDA): 213105
application number: ANDA213105
careone allergy reliefCETIRIZINE HYDROCHLORIDERetail Business Services, LLC6d94d302-b79a-4143-bb3c-c74da2a6a72e2022-10-20WarningsExact identifier
application applno (ANDA): 213105
application number: ANDA213105
Allergy ReliefCETIRIZINE HCLCare One (Retail Business Services, LLC.)04a6087e-d854-4e70-9d89-3971890a44a32022-10-20WarningsExact identifier
application applno (ANDA): 213105
application number: ANDA213105
Good Sense All Day AllergyCETIRIZINE HYDROCHLORIDEL. Perrigo Company5b1203c7-9678-4cee-9d7b-6510da2955612022-09-08WarningsExact identifier
application applno (ANDA): 213105
application number: ANDA213105
dg health all day allergyCETIRIZINE HYDROCHLORIDEDolgencorp Inc6baa66e7-93df-43d9-a301-5d9c14274c992022-04-01WarningsExact identifier
application applno (ANDA): 213105
application number: ANDA213105
allergy reliefCETIRIZINE HYDROCHLORIDEPublix Super Markets Inc268170c9-b6a7-4851-b7d3-33dd1d733e392022-03-07WarningsExact identifier
application applno (ANDA): 213105
application number: ANDA213105

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014675cetirizine HCl 10 MG 24HR Oral CapsulePSN0face45c-af24-3559-e063-6294a90abde56
1020023ZyrTEC 10 MG Oral CapsulePSN0face45c-af24-3559-e063-6294a90abde56
1020023cetirizine hydrochloride 10 MG Oral Capsule [Zyrtec]SBD0face45c-af24-3559-e063-6294a90abde56
1014675cetirizine hydrochloride 10 MG Oral CapsuleSCD0face45c-af24-3559-e063-6294a90abde56
1014675cetirizine HCl 10 MG 24 HR Oral CapsuleSY0face45c-af24-3559-e063-6294a90abde56
1020023Zyrtec (cetirizine dihydrochloride 10 MG) Oral CapsuleSY0face45c-af24-3559-e063-6294a90abde56
1020023Zyrtec 10 MG Oral CapsuleSY0face45c-af24-3559-e063-6294a90abde56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50580-786-12505800786121 BOTTLE in 1 PACKAGE (50580-786-12) / 12 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2024-04-15NoNoCurrent
50580-786-13505800786131 BOTTLE in 1 CARTON (50580-786-13) / 12 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2024-12-01NoNoCurrent
50580-786-25505800786251 BOTTLE in 1 PACKAGE (50580-786-25) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2024-04-15NoNoCurrent
50580-786-26505800786261 BOTTLE in 1 CARTON (50580-786-26) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2024-12-01NoNoCurrent
50580-786-40505800786401 BOTTLE in 1 PACKAGE (50580-786-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2024-04-15NoNoCurrent
50580-786-41505800786411 BOTTLE in 1 CARTON (50580-786-41) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2024-12-01NoNoCurrent
50580-786-655058007866565 CAPSULE, LIQUID FILLED in 1 PACKAGE, COMBINATION (50580-786-65) 2024-04-15NoNoCurrent
50580-786-665058007866665 CAPSULE, LIQUID FILLED in 1 PACKAGE (50580-786-66) 2024-12-01NoNoCurrent