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United States · US · US:41163-593_26bb9c64-c1af-409a-852e-3b2084de8b6a

equaline naproxen sodium 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 · 1

  • ndc11
    4116359371
    1 BOTTLE in 1 CARTON (41163-593-71) / 50 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
TC2D6JAD40
DIPHENHYDRAMINE HYDROCHLORIDE
RxCUI 1362
Orange Book
A208499
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "TC2D6JAD40",
    "rxcui": "1362",
    "inchikey": "PCHPORCSPXIHLZ-UHFFFAOYSA-N",
    "display_name": "DIPHENHYDRAMINE HYDROCHLORIDE",
    "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": "41163-593_26bb9c64-c1af-409a-852e-3b2084de8b6a",
  "productndc": "41163-593",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "208499",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "25MG;220MG",
        "product_no": "001",
        "approval_date": "May 10, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM",
  "proprietary_name": "equaline naproxen sodium pm",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA208499",
  "marketing_category": "ANDA",
  "nonproprietary_name": "diphenhydramine hydrochloride, naproxen sodium",
  "start_marketing_date": "20191217",
  "active_numerator_strength": "25; 220"
}

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