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United States · US · US:41163-599_4fc293f4-69f6-4050-a780-bed58bb68671

equaline mucus dm

Orange BookUNIISPLATC R05DA

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

Identification

ManufacturerUnited Natural Foods, Inc. dba UNFI
CountryUS (United States)
ATC codeR05DA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4116359901
    1 BOTTLE in 1 CARTON (41163-599-01) / 20 TABLET, EXTENDED RELEASE in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
9D2RTI9KYH
DEXTROMETHORPHAN HYDROBROMIDE
RxCUI 102490
Orange Book
A207602
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "9D2RTI9KYH",
    "rxcui": "102490",
    "inchikey": "STTADZBLEUMJRG-IKNOHUQMSA-N",
    "display_name": "DEXTROMETHORPHAN HYDROBROMIDE",
    "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": "41163-599_4fc293f4-69f6-4050-a780-bed58bb68671",
  "productndc": "41163-599",
  "dosage_form": "TABLET, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "207602",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "60MG;1.2GM",
        "product_no": "001",
        "approval_date": "Mar 5, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "30MG;600MG",
        "product_no": "002",
        "approval_date": "Mar 5, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN",
  "proprietary_name": "equaline mucus dm",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA207602",
  "marketing_category": "ANDA",
  "nonproprietary_name": "dextromethorphan hydrobromide, guaifenesin",
  "start_marketing_date": "20200218",
  "active_numerator_strength": "30; 600"
}

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