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United States · US · US:41163-050_d06f41f5-6ade-4964-a941-d8fc41a39529

equaline ibuprofen pm

Orange BookUNIISPLATC D04AA

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

Identification

ManufacturerUnited Natural Foods, Inc. dba UNFI
CountryUS (United States)
ATC codeD04AA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    4116305027
    1 BOTTLE in 1 CARTON (41163-050-27) / 80 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    4116305058
    1 BOTTLE in 1 CARTON (41163-050-58) / 40 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    4116305060
    1 BOTTLE in 1 CARTON (41163-050-60) / 20 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
4OD433S209
DIPHENHYDRAMINE CITRATE
RxCUI 82004
Orange Book
A079113
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "4OD433S209",
    "rxcui": "82004",
    "inchikey": "SPCKHVPPRJWQRZ-UHFFFAOYSA-N",
    "display_name": "DIPHENHYDRAMINE CITRATE",
    "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": "41163-050_d06f41f5-6ade-4964-a941-d8fc41a39529",
  "productndc": "41163-050",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "079113",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "38MG;200MG",
        "product_no": "001",
        "approval_date": "Dec 22, 2008"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DIPHENHYDRAMINE CITRATE; IBUPROFEN",
  "proprietary_name": "equaline ibuprofen pm",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA079113",
  "marketing_category": "ANDA",
  "nonproprietary_name": "diphenhydramine citrate, ibuprofen",
  "start_marketing_date": "20090302",
  "active_numerator_strength": "38; 200"
}

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