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United States · US · US:51316-260_efb68be9-99c9-4254-a8fa-daae8eb75f28

Childrens Allergy

Orange BookUNIISPLATC R06AX26

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

Identification

ManufacturerCVS PHARMACY, INC
CountryUS (United States)
ATC codeR06AX26
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5131626004
    1 BOTTLE, PLASTIC in 1 BOX (51316-260-04) / 118 mL in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)
2S068B75ZU
FEXOFENADINE HYDROCHLORIDE
RxCUI 236474
Orange Book
A203330
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "2S068B75ZU",
    "rxcui": "236474",
    "inchikey": "RRJFVPUCXDGFJB-UHFFFAOYSA-N",
    "display_name": "FEXOFENADINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "436c0126-4ff3-c082-e063-6294a90a3d72": {
      "match": "brand_token",
      "title": "CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [KESIN PHARMA CORPORATION]",
      "spl_version": "2",
      "published_date": "2026-06-01"
    }
  },
  "productid": "51316-260_efb68be9-99c9-4254-a8fa-daae8eb75f28",
  "productndc": "51316-260",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "203330",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "30MG/5ML",
        "product_no": "001",
        "approval_date": "Nov 18, 2014"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "30MG/5ML",
        "product_no": "002",
        "approval_date": "Nov 18, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "FEXOFENADINE HYDROCHLORIDE",
  "proprietary_name": "Childrens Allergy",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA203330",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fexofenadine HCl",
  "start_marketing_date": "20231015",
  "active_numerator_strength": "30"
}

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