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United States · US · US:51316-197_a8280495-9b25-4489-95c2-2e7b55789674

CHILDRENS ALLERGY

In shortageOrange BookUNIISPLATC D07AC17

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

Identification

ManufacturerCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
CountryUS (United States)
ATC codeD07AC17
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5131619708
    1 BOTTLE in 1 CARTON (51316-197-08) / 72 SPRAY, METERED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
O2GMZ0LF5W
FLUTICASONE PROPIONATE
RxCUI 50121
Orange Book
A207957
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Fluticasone Propionate; Salmeterol Xinafoate Powder
Raw payload (JSON)
{
  "unii": {
    "unii": "O2GMZ0LF5W",
    "rxcui": "50121",
    "inchikey": "WMWTYOKRWGGJOA-CENSZEJFSA-N",
    "display_name": "FLUTICASONE PROPIONATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "NASAL",
  "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": "51316-197_a8280495-9b25-4489-95c2-2e7b55789674",
  "productndc": "51316-197",
  "dosage_form": "SPRAY, METERED",
  "orange_book": {
    "appl_no": "207957",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "0.05MG/SPRAY",
        "product_no": "001",
        "approval_date": "May 26, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "FLUTICASONE PROPIONATE",
  "shortage_reason": "Fluticasone Propionate; Salmeterol Xinafoate Powder",
  "shortage_status": "current",
  "proprietary_name": "CHILDRENS ALLERGY",
  "active_ingred_unit": "ug/1",
  "application_number": "ANDA207957",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fluticasone Propionate",
  "start_marketing_date": "20240612",
  "active_numerator_strength": "50"
}

Related drugs

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