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United States · US · US:11822-0650_fd0c9dad-76a4-411b-b358-2bfd3c181159

sinus pressure and congestion relief

Orange BookUNIISPLATC R01BA52

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

Identification

ManufacturerRite Aid Corporation
CountryUS (United States)
ATC codeR01BA52
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    1182206506
    20 BLISTER PACK in 1 CARTON (11822-0650-6) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
6V9V2RYJ8N
PSEUDOEPHEDRINE HYDROCHLORIDE
RxCUI 91168
Orange Book
A075153
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": {
    "e9dd2d7b-0a19-4a42-b51e-b9914f02406e": {
      "match": "brand_token",
      "title": "SINUS CONGESTION AND PAIN DAYTIME NON-DROWSY (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [H E B]",
      "spl_version": "15",
      "published_date": "2026-05-25"
    }
  },
  "productid": "11822-0650_fd0c9dad-76a4-411b-b358-2bfd3c181159",
  "productndc": "11822-0650",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "075153",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "120MG",
        "product_no": "001",
        "approval_date": "Feb 26, 1999"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "PSEUDOEPHEDRINE HYDROCHLORIDE",
  "proprietary_name": "sinus pressure and congestion relief",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075153",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Pseudoephedrine HCl",
  "start_marketing_date": "19990830",
  "active_numerator_strength": "120"
}

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