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United States · US · US:41163-475_c99843ad-3ee8-4fc0-843d-75ed4d53eebe

Equaline childrens all day allergy

Orange BookUNIISPLATC R06AE

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerUnited Natural Foods, Inc. dba UNFI
CountryUS (United States)
ATC codeR06AE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4116347526
    1 BOTTLE in 1 CARTON (41163-475-26) / 118 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A204226
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": {
    "8fc2389c-9657-4dbe-a32b-df8245fc67ca": {
      "match": "brand_token",
      "title": "EQUALINE DAYTIME AND NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [UNITED NATURAL FOODS, INC. DBA UNFI]",
      "spl_version": "10",
      "published_date": "2026-05-21"
    }
  },
  "productid": "41163-475_c99843ad-3ee8-4fc0-843d-75ed4d53eebe",
  "productndc": "41163-475",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "204226",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG/5ML",
        "product_no": "001",
        "approval_date": "Sep 9, 2013"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CETIRIZINE HYDROCHLORIDE",
  "proprietary_name": "Equaline childrens all day allergy",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA204226",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cetirizine HCl",
  "start_marketing_date": "20151117",
  "active_numerator_strength": "5"
}

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