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United States · US · US:36800-505_285fde8b-8485-b050-e063-6294a90a0dab

Sinus Congestion and Pain Severe

In shortageUNIISPLATC N02BE

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

Identification

ManufacturerTopCare
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    3680050505
    2 BLISTER PACK in 1 CARTON (36800-505-05) / 12 TABLET, COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Acetaminophen; Oxycodone Hydrochloride Tablet
Raw payload (JSON)
{
  "unii": {
    "unii": "362O9ITL9D",
    "rxcui": "161",
    "inchikey": "RZVAJINKPMORJF-UHFFFAOYSA-N",
    "display_name": "ACETAMINOPHEN",
    "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": "36800-505_285fde8b-8485-b050-e063-6294a90a0dab",
  "productndc": "36800-505",
  "dosage_form": "TABLET, COATED",
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "Sinus Congestion and Pain Severe",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "M012",
  "marketing_category": "OTC MONOGRAPH DRUG",
  "nonproprietary_name": "ACETAMINOPHEN, GUAIFENESIN, and PHENYLEPHRINE HYDROCHLORIDE",
  "start_marketing_date": "20130701",
  "active_numerator_strength": "325; 200; 5"
}

Related drugs

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