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United States · US · US:0113-5300_b117358c-f4ca-4ea8-95ee-88a42cc05040

good sense dual action

In shortageOrange BookUNIISPLATC N02BE

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

Identification

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

Packs · 2

  • ndc11
    0113530016
    1 BOTTLE in 1 CARTON (0113-5300-16) / 144 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    0113530068
    1 BOTTLE in 1 CARTON (0113-5300-68) / 36 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A214836
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": {
    "d503b10f-85cd-4bb8-9dec-82d651d525fa": {
      "match": "brand_token",
      "title": "GOOD NEIGHBOR PHARMACY EARWAX REMOVAL (CARBAMIDE PEROXIDE) KIT [AMERISOURCE BERGEN]",
      "spl_version": "3",
      "published_date": "2026-06-01"
    }
  },
  "productid": "0113-5300_b117358c-f4ca-4ea8-95ee-88a42cc05040",
  "productndc": "0113-5300",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "214836",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "250MG;125MG",
        "product_no": "001",
        "approval_date": "Feb 28, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ACETAMINOPHEN; IBUPROFEN",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "good sense dual action",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA214836",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Acetaminophen, Ibuprofen",
  "start_marketing_date": "20230301",
  "active_numerator_strength": "250; 125"
}

Related drugs

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