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United States · US · US:41226-716_002fdf94-eba4-9115-e063-6294a90a1582

Dual Action

In shortageOrange BookUNIISPLATC N02BE

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

Identification

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

Packs · 1

  • ndc11
    4122671649
    1 BOTTLE in 1 CARTON (41226-716-49) / 144 TABLET in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A216994
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": {
    "8d9a0c56-ef22-45a6-8b1d-d2b2f3247210": {
      "match": "brand_token",
      "title": "DUAL ACTION BACK PAIN RELIEVER (ACETAMINOPHEN, IBUPROFEN) TABLET, FILM COATED [MEIJER, INC.]",
      "spl_version": "2",
      "published_date": "2026-03-23"
    }
  },
  "productid": "41226-716_002fdf94-eba4-9115-e063-6294a90a1582",
  "productndc": "41226-716",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "216994",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "250MG;125MG",
        "product_no": "001",
        "approval_date": "Jul 10, 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": "Dual Action",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA216994",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Acetaminophen, Ibuprofen",
  "start_marketing_date": "20230711",
  "active_numerator_strength": "250; 125"
}

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