NDC 50580-728-50 - ZYRTEC-D Allergy Plus Congestion

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
50580-728
Requested NDC
50580-728-50
Package NDCs from labels
50580-728-12, 50580-728-24, 50580-728-25, 50580-728-50
Manufacturer
Kenvue Brands LLC
Effective date
2025-06-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ZYRTEC-D Allergy Plus Congestion - Kenvue Brands LLCKenvue Brands LLC2025-06-12HUMAN OTC DRUG LABEL
ZYRTEC-D ®Physicians Total Care, Inc.2012-05-23HUMAN OTC DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-728-12ZYRTEC-DAllergy Plus Congestion6 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE610
50580-728-12ZYRTEC-DAllergy Plus Congestion2 in 1 CARTONTABLET, FILM COATED, EXTENDED RE210
50580-728-24ZYRTEC-DAllergy Plus Congestion4 in 1 CARTONTABLET, FILM COATED, EXTENDED RE410
50580-728-24ZYRTEC-DAllergy Plus Congestion6 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE610
50580-728-25ZYRTEC-DAllergy Plus Congestion6 in 1 BLISTER PACKTABLET, FILM COATED, EXTENDED RE610
50580-728-25ZYRTEC-DAllergy Plus Congestion4 in 1 CARTONTABLET, FILM COATED, EXTENDED RE410

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-728ZYRTEC-D ALLERGY PLUS CONGESTION (CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [KENVUE BRANDS LLC]9Current NDC, Legacy NDC, 6 package rows20241109_1e8eb279-3522-40e4-8062-06b5354f0d29.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-728-12EA - Each50580-728d0f8dc94-f3d3-4f79-9906-bf744f35ba7c12012-07-24
50580-728-24EA - Each50580-7282ab6ec96-62b6-4493-a4fd-83a4e755e01012012-07-24
50580-728-50EA - Each50580-72877517b86-5159-4401-91d0-bba7da9265e812012-07-24
50580-728-52EA - Each50580-72847ad8f49-81c5-4e64-b5ba-f4416dbe1a7012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Cetirizine HydrochlorideACTIVE INGREDIENT64O047KTOAZYRTEC-D ALLERGY AND CONGESTION (CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]2
Pseudoephedrine HydrochlorideACTIVE INGREDIENT6V9V2RYJ8NZYRTEC-D ALLERGY AND CONGESTION (CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]2
CetirizineACTIVE MOIETYYO7261ME24ZYRTEC-D ALLERGY AND CONGESTION (CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]2
PseudoephedrineACTIVE MOIETY7CUC9DDI9FZYRTEC-D ALLERGY AND CONGESTION (CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UZYRTEC-D ALLERGY AND CONGESTION (CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]2
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48ZYRTEC-D ALLERGY AND CONGESTION (CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]2
hypromellosesINACTIVE INGREDIENT3NXW29V3WOZYRTEC-D ALLERGY AND CONGESTION (CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]2
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XZYRTEC-D ALLERGY AND CONGESTION (CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]2
magnesium stearateINACTIVE INGREDIENT70097M6I30ZYRTEC-D ALLERGY AND CONGESTION (CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]2
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1AZYRTEC-D ALLERGY AND CONGESTION (CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]2
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4ZYRTEC-D ALLERGY AND CONGESTION (CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPZYRTEC-D ALLERGY AND CONGESTION (CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [MCNEIL CONSUMER HEALTHCARE DIV MCNEIL-PPC, INC]2
Cetirizine HydrochlorideACTIVE INGREDIENT64O047KTOAZYRTEC D ALLERGY AND CONGESTION (CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
Pseudoephedrine HydrochlorideACTIVE INGREDIENT6V9V2RYJ8NZYRTEC D ALLERGY AND CONGESTION (CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
CetirizineACTIVE MOIETYYO7261ME24ZYRTEC D ALLERGY AND CONGESTION (CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
PseudoephedrineACTIVE MOIETY7CUC9DDI9FZYRTEC D ALLERGY AND CONGESTION (CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UZYRTEC D ALLERGY AND CONGESTION (CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ZYRTEC D ALLERGY AND CONGESTION (CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOZYRTEC D ALLERGY AND CONGESTION (CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XZYRTEC D ALLERGY AND CONGESTION (CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ZYRTEC D ALLERGY AND CONGESTION (CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AZYRTEC D ALLERGY AND CONGESTION (CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ZYRTEC D ALLERGY AND CONGESTION (CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPZYRTEC D ALLERGY AND CONGESTION (CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1

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 164 · 3,280 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CETIRIZINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDEBAJAJ MEDICAL, LLC36b6d0e4-8da5-9df5-e063-6294a90af3262026-10-01WarningsExact identifier
unii: 64O047KTOA
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Allergy ReliefCETIRIZINE HYDROCHLORIDELIDL US LLCe5fd935d-5b60-7270-e053-2995a90a71412026-09-09WarningsExact identifier
unii: 64O047KTOA
all day allergyCETIRIZINE HYDROCHLORIDERite Aid Corporationbcbb9f5a-10b6-4a5e-a237-d29693d781032026-09-04WarningsExact identifier
unii: 64O047KTOA
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
childrens cetirizine hydrochlorideCETIRIZINE HCLATLANTIC BIOLOGICALS CORP.cb47e536-8eed-4a32-b9c2-e8535fb938862026-09-01WarningsExact identifier
unii: 64O047KTOA
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEWALGREEN CO.4daddd32-615f-aedf-e063-6394a90a5b092026-09-01WarningsExact identifier
unii: 6V9V2RYJ8N
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
Allergy ReliefCETIRIZINE HCLCVS PHARMACY, INCfb850a4c-7ac1-4993-b6ea-5c8d42e177032026-08-26WarningsExact identifier
unii: 64O047KTOA
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Argentum QuartzARGENTUM QUARTZUriel Pharmacy Inc.765c8c8f-0727-45da-a77e-c3907a3d07932026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Endometrium ArgentumENDOMETRIUM ARGENTUMUriel Pharmacy Incd2d1428a-c8b5-9529-e053-2995a90a23432026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
S12 AIRBORNEALFALFA, ALLIUM SATIVUM, ARSENICUM IODATUM, BARLEY, BETULA PUBESCENS, BROWN RICE, CORN GRAIN, EUPHRASIA OFFICINALIS, FEATHER MIX, HAIR MIX, HISTAMINUM, HOUSE DUST MITE, LOLIUM PERENNE, OAT, PERFOLIATE HONEYSUCKLE, PHLEUM PRATENSE, POLLEN MIX, RYE, SABADILLA, SILICEA, SKIN MIX, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TEREBINTHINA, WHEATApex Energetics Inc.bb0036c3-1e4d-5750-e053-2995a90ae8952026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Cetirizine Hydrochloride and Pseudoephedrine HydrochlorideCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEAurohealth LLC26f2c3c1-a2f2-474a-950a-8cfe07f289fa2026-08-25WarningsExact identifier
rxcui: 1014571
unii: 64O047KTOA
unii: 6V9V2RYJ8N
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEAurohealth LLC17e93c22-1ff7-4af9-bd5a-448836aec65f2026-08-25WarningsExact identifier
unii: 64O047KTOA
Childrens Cetirizine HydrochlorideCETIRIZINE HYDROCHLORIDEAurohealth LLCcd895177-3c25-4a1b-81a0-b85f4877787a2026-08-25WarningsExact identifier
unii: 64O047KTOA
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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