Allergy Relief

Orange BookUNIISPLATC R06AE

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

Identification

ManufacturerCVS Pharmacy

CountryUS (United States)

ATC codeR06AE

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 10

ndc11
5977945800
1 BOTTLE in 1 CARTON (59779-458-00) / 60 TABLET, FILM COATED in 1 BOTTLE
ndc11
5977945801
2 BOTTLE in 1 CARTON (59779-458-01) / 90 TABLET, FILM COATED in 1 BOTTLE (59779-458-05)
ndc11
5977945839
1 BOTTLE in 1 CARTON (59779-458-39) / 30 TABLET, FILM COATED in 1 BOTTLE
ndc11
5977945858
1 BOTTLE in 1 CARTON (59779-458-58) / 40 TABLET, FILM COATED in 1 BOTTLE
ndc11
5977945866
14 BLISTER PACK in 1 CARTON (59779-458-66) / 1 TABLET, FILM COATED in 1 BLISTER PACK
ndc11
5977945870
2 BOTTLE in 1 CARTON (59779-458-70) / 120 TABLET, FILM COATED in 1 BOTTLE
ndc11
5977945875
1 BOTTLE in 1 CARTON (59779-458-75) / 90 TABLET, FILM COATED in 1 BOTTLE
ndc11
5977945876
1 BOTTLE in 1 CARTON (59779-458-76) / 120 TABLET, FILM COATED in 1 BOTTLE
ndc11
5977945888
1 BOTTLE in 1 CARTON (59779-458-88) / 365 TABLET, FILM COATED in 1 BOTTLE
ndc11
5977945895
1 BOTTLE in 1 CARTON (59779-458-95) / 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": "59779-458_131dd209-e1fe-4dd4-9523-8c0da50b78f4",
  "productndc": "59779-458",
  "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": "20090114",
  "active_numerator_strength": "10"
}

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