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United States · US · US:41163-103_4348c154-9502-40c5-84d1-816ccd1ac90f

equaline dual action pain reliever

In shortageOrange BookUNIISPLATC N02BE

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

Identification

ManufacturerUnited Natural Foods, Inc. dba UNFI
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4116310368
    1 BOTTLE in 1 CARTON (41163-103-68) / 36 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    4116310389
    1 BOTTLE in 1 CARTON (41163-103-89) / 18 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": {
    "8fc2389c-9657-4dbe-a32b-df8245fc67ca": {
      "match": "brand_token",
      "title": "EQUALINE DAYTIME AND NIGHTTIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) KIT [UNITED NATURAL FOODS, INC. DBA UNFI]",
      "spl_version": "10",
      "published_date": "2026-05-21"
    }
  },
  "productid": "41163-103_4348c154-9502-40c5-84d1-816ccd1ac90f",
  "productndc": "41163-103",
  "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": "equaline dual action pain reliever",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA214836",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Acetaminophen, Ibuprofen",
  "start_marketing_date": "20240321",
  "active_numerator_strength": "250; 125"
}

Related drugs

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