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United States · US · US:41520-553_8e116cfd-618c-469f-b384-f60648d81ed3

careone childrens allergy relief

In shortageOrange BookUNIISPLATC D07AC17

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

Identification

ManufacturerAmerican Sales Company
CountryUS (United States)
ATC codeD07AC17
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4152055302
    1 BOTTLE, SPRAY in 1 CARTON (41520-553-02) / 60 SPRAY, METERED in 1 BOTTLE, SPRAY

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": {
    "206f5483-7de1-4bc3-af27-190e211bcb95": {
      "match": "brand_token",
      "title": "CAREONE ACID RELIEF (FAMOTIDINE) TABLET, FILM COATED [AMERICAN SALES COMPANY]",
      "spl_version": "9",
      "published_date": "2026-05-25"
    }
  },
  "productid": "41520-553_8e116cfd-618c-469f-b384-f60648d81ed3",
  "productndc": "41520-553",
  "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": "careone childrens allergy relief",
  "active_ingred_unit": "ug/1",
  "application_number": "ANDA207957",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fluticasone Propionate",
  "start_marketing_date": "20190823",
  "active_numerator_strength": "50"
}

Related drugs

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