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United States · US · US:52183-199_0a2a4a89-e8ee-46a0-8187-3e1192c39985

NasalCrom

In shortageOrange BookUNIISPLATC R03BC01

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

Identification

ManufacturerPrestige Brands Holdings, Inc.
CountryUS (United States)
ATC codeR03BC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5218319913
    1 BOTTLE, PUMP in 1 CARTON (52183-199-13) / 200 SPRAY, METERED in 1 BOTTLE, PUMP

Annotations

UNII (FDA Substance ID)
Q2WXR1I0PK
CROMOLYN SODIUM
RxCUI 3538
Orange Book
A075702
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Cromolyn Sodium Concentrate
Raw payload (JSON)
{
  "unii": {
    "unii": "Q2WXR1I0PK",
    "rxcui": "3538",
    "inchikey": "VLARUOGDXDTHEH-UHFFFAOYSA-L",
    "display_name": "CROMOLYN SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "NASAL",
  "spl_meta": {
    "b34d36ca-4df4-458c-af0f-c0d0c9a025d9": {
      "match": "brand_token",
      "title": "NASALCROM (CROMOLYN SODIUM) SPRAY, METERED [PRESTIGE BRANDS HOLDINGS, INC.]",
      "spl_version": "13",
      "published_date": "2025-12-25"
    }
  },
  "productid": "52183-199_0a2a4a89-e8ee-46a0-8187-3e1192c39985",
  "productndc": "52183-199",
  "dosage_form": "SPRAY, METERED",
  "orange_book": {
    "appl_no": "075702",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "5.2MG/SPRAY",
        "product_no": "001",
        "approval_date": "Jul 3, 2001"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CROMOLYN SODIUM",
  "shortage_reason": "Cromolyn Sodium Concentrate",
  "shortage_status": "current",
  "proprietary_name": "NasalCrom",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075702",
  "marketing_category": "ANDA",
  "nonproprietary_name": "cromolyn sodium",
  "start_marketing_date": "20091029",
  "active_numerator_strength": "5.2"
}

Related drugs

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