ZYRTEC-D

Product NDC
50580-719
11-digit product format
505800719
Labeler code
50580
Product ID
50580-719_4ec5aa70-7743-2cf9-e063-6394a90a06dd
Type
HUMAN OTC DRUG
Nonproprietary name
Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Kenvue Brands LLC
Application
NDA021150
Marketing category
NDA
Marketing start
2023-02-28
Substance
CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
5; 120 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [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
N021150-002ZYRTEC-D 12 HOURCETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2007-11-09

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021150-002ZYRTEC-D 12 HOUR5MG;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2007-11-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021150-002ZYRTEC-D 12 HOUR5MG;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2007-11-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08N021150-002ZYRTEC-D 12 HOUR5MG;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2007-11-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021150-002ZYRTEC-D 12 HOUR5MG;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2007-11-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021150-002ZYRTEC-D 12 HOUR5MG;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2007-11-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021150-002ZYRTEC-D 12 HOUR5MG;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2007-11-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021150-002ZYRTEC-D 12 HOUR5MG;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2007-11-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021150-002ZYRTEC-D 12 HOUR5MG;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2007-11-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021150-002ZYRTEC-D 12 HOUR5MG;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2007-11-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021150-002ZYRTEC-D 12 HOUR5MG;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2007-11-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021150-002ZYRTEC-D 12 HOUR5MG;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2007-11-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021150-002ZYRTEC-D 12 HOUR5MG;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2007-11-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021150-002ZYRTEC-D 12 HOUR5MG;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2007-11-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021150-002ZYRTEC-D 12 HOUR5MG;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2007-11-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021150-002ZYRTEC-D 12 HOUR5MG;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2007-11-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021150-002ZYRTEC-D 12 HOUR5MG;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2007-11-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021150-002ZYRTEC-D 12 HOUR5MG;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2007-11-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021150-002ZYRTEC-D 12 HOUR5MG;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2007-11-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021150-002ZYRTEC-D 12 HOUR5MG;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2007-11-09bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021150-002ZYRTEC-D 12 HOUR5MG;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2007-11-09782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021150-002ZYRTEC-D 12 HOUR5MG;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2007-11-0987673890dc5c…
2021-03-12 10:30 UTC2021-03N021150-002ZYRTEC-D 12 HOUR5MG;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2007-11-095aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021150-002ZYRTEC-D 12 HOUR5MG;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2007-11-098869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021150-002ZYRTEC-D 12 HOUR5MG;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2007-11-09c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021150-002ZYRTEC-D 12 HOUR5MG;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2007-11-093f01610625f2…
2019-09-15 20:21 UTC2019-09N021150-002ZYRTEC-D 12 HOUR5MG;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2007-11-09b00525d2431f…
2019-07-19 19:46 UTC2019-07N021150-002ZYRTEC-D 12 HOUR5MG;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2007-11-09ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021150-002ZYRTEC-D 12 HOUR5MG;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2007-11-096a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021150-002ZYRTEC-D 12 HOUR5MG;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2007-11-091c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021150-002ZYRTEC-D 12 HOUR5MG;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2007-11-09ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021150-002ZYRTEC-D 12 HOUR5MG;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2007-11-09a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021150-002ZYRTEC-D 12 HOUR5MG;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2007-11-099b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021150-002ZYRTEC-D 12 HOUR5MG;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2007-11-09a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021150-002ZYRTEC-D 12 HOUR5MG;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2007-11-093f0d92c62455…
2023-05-13 08:27 UTC2023-05N021150-002ZYRTEC-D 12 HOUR5MG;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2007-11-09053a50430f4f…
2023-01-26 05:58 UTC2023-01N021150-002ZYRTEC-D 12 HOUR5MG;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2007-11-093bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021150-002ZYRTEC-D 12 HOUR5MG;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2007-11-093a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021150-002ZYRTEC-D 12 HOUR5MG;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2007-11-09f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021150-002ZYRTEC-D 12 HOUR5MG;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2007-11-09e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021150-002ZYRTEC-D 12 HOUR5MG;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2007-11-09cb3db0bc1861…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021150-00270148672022-06-10Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021150-00272266142022-06-10U-2955c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021150-00270148672022-06-10Drug product5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021150-00272266142022-06-10U-2955d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021150-00270148672022-06-10Drug product4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021150-00272266142022-06-10U-2954b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021150-00264690092019-07-13U-295Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021150-00270148672022-06-10Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021150-00272266142022-06-10U-29574a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021150-00270148672022-06-10Drug productbb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021150-00272266142022-06-10U-295bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021150-00270148672022-06-10Drug product782e0a99824c…
2021-12-28 21:50 UTC2021-12N021150-00272266142022-06-10U-295782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021150-00270148672022-06-10Drug product87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021150-00272266142022-06-10U-29587673890dc5c…
2021-03-12 10:30 UTC2021-03N021150-00270148672022-06-10Drug product5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N021150-00272266142022-06-10U-2955aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021150-00270148672022-06-10Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021150-00272266142022-06-10U-2958869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021150-00270148672022-06-10Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021150-00272266142022-06-10U-295c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021150-00264690092019-07-13U-295Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021150-00270148672022-06-10Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021150-00272266142022-06-10U-2953f01610625f2…
2019-09-15 20:21 UTC2019-09N021150-00264690092019-07-13U-295Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021150-00270148672022-06-10Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021150-00272266142022-06-10U-295b00525d2431f…
2019-07-19 19:46 UTC2019-07N021150-00264690092019-07-13U-295Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021150-00270148672022-06-10Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021150-00272266142022-06-10U-295ea99ee380514…
2023-01-26 05:58 UTC2023-01N021150-00270148672022-06-10Drug product3bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01N021150-00272266142022-06-10U-2953bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021150-00270148672022-06-10Drug product3a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021150-00272266142022-06-10U-2953a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021150-00270148672022-06-10Drug productf41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N021150-00272266142022-06-10U-295f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021150-00270148672022-06-10Drug producte64feba35796…
2022-09-29 23:25 UTC2022-09N021150-00272266142022-06-10U-295e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021150-00270148672022-06-10Drug productcb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021150-00272266142022-06-10U-295cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
ZYRTEC-D
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CETIRIZINE HYDROCHLORIDE5 mg/1
PSEUDOEPHEDRINE HYDROCHLORIDE120 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
64O047KTOAInternal UNII lookup
6V9V2RYJ8NInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1014571Internal RxNorm lookup
1014583Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f1ecf9ba-1c03-7fb7-e053-2a95a90a875aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
c505bb17-4ff9-45f9-ac2d-bb9c8c9d35beProduct name120200304
a255659f-db40-429d-8c07-5f173f330d9cProduct name120190402
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-719-12ZYRTEC-D2 in 1 CARTONTABLET, FILM COATED, EXTENDED RE26
50580-719-12ZYRTEC-D6 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE66
50580-719-24ZYRTEC-D4 in 1 CARTONTABLET, FILM COATED, EXTENDED RE46
50580-719-24ZYRTEC-D6 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE66

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-719-12EA - Each50580-71946184429-04f2-40ca-a85f-3ae4eb72c2aa12023-06-06
50580-719-24EA - Each50580-719a371d5a4-5df3-481a-8f99-4496068de2fb12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-719ZYRTEC-D (CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [KENVUE BRANDS LLC]4Current NDC, 4 package rows20250323_f1ecf9ba-1c03-7fb7-e053-2a95a90a875a.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZYRTEC-DCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEKenvue Brands LLCf1ecf9ba-1c03-7fb7-e053-2a95a90a875a2026-04-06WarningsExact identifier
application applno (NDA): 021150
application number: NDA021150
ndc (product): 50580-719
ZYRTEC-D Allergy Plus CongestionCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEKenvue Brands LLC1e8eb279-3522-40e4-8062-06b5354f0d292025-06-12WarningsExact identifier
application applno (NDA): 021150
application number: NDA021150

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1014571cetirizine HCl 5 MG / pseudoephedrine HCl 120 MG 12HR Extended Release Oral TabletPSNf1ecf9ba-1c03-7fb7-e053-2a95a90a875a6
1014583ZyrTEC-D Allergy & Congestion 5 MG / 120 MG 12HR Extended Release Oral TabletPSNf1ecf9ba-1c03-7fb7-e053-2a95a90a875a6
101458312 HR cetirizine hydrochloride 5 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral Tablet [Zyrtec-D]SBDf1ecf9ba-1c03-7fb7-e053-2a95a90a875a6
101457112 HR cetirizine hydrochloride 5 MG / pseudoephedrine hydrochloride 120 MG Extended Release Oral TabletSCDf1ecf9ba-1c03-7fb7-e053-2a95a90a875a6
1014571cetirizine dihydrochloride 5 MG / pseudoephedrine HCl 120 MG 12 HR Extended Release Oral TabletSYf1ecf9ba-1c03-7fb7-e053-2a95a90a875a6
1014583Zyrtec-D (cetirizine dihydrochloride 5 MG / pseudoephedrine hydrochloride 120 MG) 12 HR Extended Release Oral TabletSYf1ecf9ba-1c03-7fb7-e053-2a95a90a875a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50580-719-12505800719122 BLISTER PACK in 1 CARTON (50580-719-12) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK2 blister pack2023-02-28NoNoCurrent
50580-719-24505800719244 BLISTER PACK in 1 CARTON (50580-719-24) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK4 blister pack2023-02-28NoNoCurrent