Zyrtec Allergy

Orange BookUNIISPLATC R06AE

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerKenvue Brands LLC

CountryUS (United States)

ATC codeR06AE

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 22

ndc11
5058072605
50 POUCH in 1 CARTON (50580-726-05) / 1 TABLET, FILM COATED in 1 POUCH
ndc11
5058072603
50 BLISTER PACK in 1 CARTON (50580-726-03) / 1 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
5058072625
2500 POUCH in 1 CASE (50580-726-25) / 1 TABLET, FILM COATED in 1 POUCH
ndc11
5058072636
1 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-36) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
ndc11
5058072640
1 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-40) / 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
ndc11
5058072645
1 BOTTLE in 1 CARTON (50580-726-45) / 45 TABLET, FILM COATED in 1 BOTTLE
ndc11
5058072650
1 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-50) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
ndc11
5058072666
75 TABLET, FILM COATED in 1 PACKAGE, COMBINATION (50580-726-66)
ndc11
5058072670
1 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-70) / 70 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
ndc11
5058072671
1 BOTTLE in 1 CARTON (50580-726-71) / 30 TABLET, FILM COATED in 1 BOTTLE
ndc11
5058072672
1 BOTTLE in 1 CARTON (50580-726-72) / 40 TABLET, FILM COATED in 1 BOTTLE
ndc11
5058072673
1 BOTTLE in 1 CARTON (50580-726-73) / 60 TABLET, FILM COATED in 1 BOTTLE
ndc11
5058072674
1 BOTTLE in 1 CARTON (50580-726-74) / 90 TABLET, FILM COATED in 1 BOTTLE
ndc11
5058072675
1 BOTTLE in 1 CARTON (50580-726-75) / 75 TABLET, FILM COATED in 1 BOTTLE
ndc11
5058072690
2 BOTTLE, PLASTIC in 1 PACKAGE (50580-726-90) / 45 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
ndc11
5058072691
2500 POUCH in 1 CARTON (50580-726-91) / 1 TABLET, FILM COATED in 1 POUCH
ndc11
5058072692
50 POUCH in 1 TRAY (50580-726-92) / 1 TABLET, FILM COATED in 1 POUCH
ndc11
5058072693
3 POUCH in 1 CARTON (50580-726-93) / 1 TABLET, FILM COATED in 1 POUCH
ndc11
5058072694
1 BOTTLE in 1 PACKAGE (50580-726-94) / 60 TABLET, FILM COATED in 1 BOTTLE
ndc11
5058072695
1 BOTTLE in 1 PACKAGE (50580-726-95) / 90 TABLET, FILM COATED in 1 BOTTLE
ndc11
5058072696
5 POUCH in 1 CARTON (50580-726-96) / 1 TABLET, FILM COATED in 1 POUCH
ndc11
5058072697
14 POUCH in 1 CARTON (50580-726-97) / 1 TABLET, FILM COATED in 1 POUCH

Annotations

UNII (FDA Substance ID)

64O047KTOA

CETIRIZINE HYDROCHLORIDE

RxCUI 203150

Orange Book

N019835

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "64O047KTOA",
    "rxcui": "203150",
    "inchikey": "PGLIUCLTXOYQMV-UHFFFAOYSA-N",
    "display_name": "CETIRIZINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "dc613bd5-70fd-1d9b-e053-2995a90a41cd": {
      "match": "brand_token",
      "title": "ZYRTEC (CETIRIZINE HYDROCHLORIDE) TABLET, CHEWABLE [KENVUE BRANDS LLC]",
      "spl_version": "9",
      "published_date": "2026-04-30"
    }
  },
  "productid": "50580-726_40cb0300-d3f3-4a66-e063-6394a90a41dc",
  "productndc": "50580-726",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "019835",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "5MG",
        "product_no": "003",
        "approval_date": "Nov 16, 2007"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "10MG",
        "product_no": "004",
        "approval_date": "Nov 16, 2007"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "5MG",
        "product_no": "005",
        "approval_date": "Nov 16, 2007"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "10MG",
        "product_no": "006",
        "approval_date": "Nov 16, 2007"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CETIRIZINE HYDROCHLORIDE",
  "proprietary_name": "Zyrtec Allergy",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA019835",
  "marketing_category": "NDA",
  "nonproprietary_name": "Cetirizine Hydrochloride",
  "start_marketing_date": "20080101",
  "active_numerator_strength": "10"
}

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