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United States · US · US:70000-0656_8eaad384-c7af-4263-b948-8623a7c06bcb

12 Hour Nasal Decongestant

Orange BookUNIISPLATC R01BA52

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

Identification

ManufacturerCARDINAL HEALTH
CountryUS (United States)
ATC codeR01BA52
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7000006561
    1 BLISTER PACK in 1 CARTON (70000-0656-1) / 10 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
6V9V2RYJ8N
PSEUDOEPHEDRINE HYDROCHLORIDE
RxCUI 91168
Orange Book
A077442
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "6V9V2RYJ8N",
    "rxcui": "91168",
    "inchikey": "BALXUFOVQVENIU-KXNXZCPBSA-N",
    "display_name": "PSEUDOEPHEDRINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "d63fff6c-a1cd-4636-b1d3-ae83be40c3f7": {
      "match": "brand_token",
      "title": "12 HR RELIEF COUGH DM (DEXTROMETHORPHAN POLISTIREX) SUSPENSION [CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]",
      "spl_version": "2",
      "published_date": "2026-04-24"
    }
  },
  "productid": "70000-0656_8eaad384-c7af-4263-b948-8623a7c06bcb",
  "productndc": "70000-0656",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "077442",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "120MG",
        "product_no": "001",
        "approval_date": "Sep 28, 2005"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "PSEUDOEPHEDRINE HYDROCHLORIDE",
  "proprietary_name": "12 Hour Nasal Decongestant",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077442",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Pseudoephedrine hydrochloride",
  "start_marketing_date": "20240516",
  "active_numerator_strength": "120"
}

Related drugs

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