allergy relief

Orange BookUNIISPLATC R06AE

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

Identification

ManufacturerWalgreen Company

CountryUS (United States)

ATC codeR06AE

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 7

ndc11
0363410139
1 BOTTLE in 1 CARTON (0363-4101-39) / 30 TABLET, FILM COATED in 1 BOTTLE
ndc11
0363410147
1 BOTTLE in 1 CARTON (0363-4101-47) / 150 TABLET, FILM COATED in 1 BOTTLE
ndc11
0363410158
1 BOTTLE in 1 CARTON (0363-4101-58) / 40 TABLET, FILM COATED in 1 BOTTLE
ndc11
0363410172
1 BOTTLE in 1 CARTON (0363-4101-72) / 60 TABLET, FILM COATED in 1 BOTTLE
ndc11
0363410175
1 BOTTLE in 1 CARTON (0363-4101-75) / 90 TABLET, FILM COATED in 1 BOTTLE
ndc11
0363410188
1 BOTTLE in 1 CARTON (0363-4101-88) / 365 TABLET, FILM COATED in 1 BOTTLE
ndc11
0363410195
1 BOTTLE in 1 CARTON (0363-4101-95) / 45 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

64O047KTOA

CETIRIZINE HYDROCHLORIDE

RxCUI 203150

Orange Book

A078336

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": {
    "934c7b91-3cba-47f0-8efa-77216f3f15c4": {
      "match": "brand_token",
      "title": "ALLERGY RELIEF CHILDRENS (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [AMERISOURCE BERGEN]",
      "spl_version": "14",
      "published_date": "2026-06-01"
    }
  },
  "productid": "0363-4101_28f9d48e-60ee-4d58-af55-0b6206044e31",
  "productndc": "0363-4101",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078336",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Dec 27, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Dec 27, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG",
        "product_no": "003",
        "approval_date": "Dec 27, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "004",
        "approval_date": "Dec 27, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CETIRIZINE HYDROCHLORIDE",
  "proprietary_name": "allergy relief",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078336",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cetirizine Hydrochloride",
  "start_marketing_date": "20211021",
  "active_numerator_strength": "10"
}

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