FLONASE

In shortageOrange BookUNIISPLATC D07AC17

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

Identification

ManufacturerHaleon US Holdings LLC

CountryUS (United States)

ATC codeD07AC17

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 10

ndc11
0135057601
1 BOTTLE in 1 CARTON (0135-0576-01) / 30 SPRAY, METERED in 1 BOTTLE
ndc11
0135057602
1 BOTTLE in 1 PACKAGE (0135-0576-02) / 60 SPRAY, METERED in 1 BOTTLE
ndc11
0135057603
1 BOTTLE in 1 PACKAGE (0135-0576-03) / 120 SPRAY, METERED in 1 BOTTLE
ndc11
0135057604
3 BOTTLE in 1 PACKAGE (0135-0576-04) / 120 SPRAY, METERED in 1 BOTTLE
ndc11
0135057612
2 BOTTLE in 1 PACKAGE (0135-0576-12) / 120 SPRAY, METERED in 1 BOTTLE
ndc11
0135057614
1 BOTTLE in 1 PACKAGE (0135-0576-14) / 144 SPRAY, METERED in 1 BOTTLE
ndc11
0135057615
2 BOTTLE in 1 PACKAGE (0135-0576-15) / 144 SPRAY, METERED in 1 BOTTLE
ndc11
0135057616
3 BOTTLE in 1 PACKAGE (0135-0576-16) / 144 SPRAY, METERED in 1 BOTTLE
ndc11
0135057617
1 BOTTLE in 1 PACKAGE (0135-0576-17) / 72 SPRAY, METERED in 1 BOTTLE
ndc11
0135057618
1 BOTTLE in 1 PACKAGE (0135-0576-18) / 90 SPRAY, METERED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

O2GMZ0LF5W

FLUTICASONE PROPIONATE

RxCUI 50121

Orange Book

N205434

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": {
    "b6134ba0-b70a-4eac-9a82-cef64b242c1d": {
      "match": "brand_token",
      "title": "FLONASE ALLERGY RELIEF (FLUTICASONE PROPIONATE) SPRAY, METERED [HALEON US HOLDINGS LLC]",
      "spl_version": "21",
      "published_date": "2024-12-23"
    }
  },
  "productid": "0135-0576_fe356980-6a1c-4830-b69c-7adb271b2e20",
  "productndc": "0135-0576",
  "dosage_form": "SPRAY, METERED",
  "orange_book": {
    "appl_no": "205434",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "0.05MG/SPRAY",
        "product_no": "001",
        "approval_date": "Jul 23, 2014"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "FLUTICASONE PROPIONATE",
  "shortage_reason": "Fluticasone Propionate; Salmeterol Xinafoate Powder",
  "shortage_status": "current",
  "proprietary_name": "FLONASE",
  "active_ingred_unit": "ug/1",
  "application_number": "NDA205434",
  "marketing_category": "NDA",
  "nonproprietary_name": "fluticasone propionate",
  "start_marketing_date": "20141204",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code D07AC17.

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