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United States · US · US:41250-158_d7794f31-7ab8-4ca1-b01b-87b955d012e2

Congestion Relief

Orange BookUNIISPLATC C01EB

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

Identification

ManufacturerMeijer Distribution Inc
CountryUS (United States)
ATC codeC01EB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4125015860
    20 BLISTER PACK in 1 CARTON (41250-158-60) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A203200
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "WK2XYI10QM",
    "rxcui": "5640",
    "inchikey": "HEFNNWSXXWATRW-UHFFFAOYSA-N",
    "display_name": "IBUPROFEN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "f43d97b1-aeb9-4ca5-8909-b28e7bf764f5": {
      "match": "brand_token",
      "title": "CONGESTION AND COUGH CHILDRENS (DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [CVS PHARMACY]",
      "spl_version": "12",
      "published_date": "2026-01-08"
    }
  },
  "productid": "41250-158_d7794f31-7ab8-4ca1-b01b-87b955d012e2",
  "productndc": "41250-158",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "203200",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "200MG;10MG",
        "product_no": "001",
        "approval_date": "Jul 3, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE",
  "proprietary_name": "Congestion Relief",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA203200",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ibuprofen, phenylephrine HCl",
  "start_marketing_date": "20140917",
  "active_numerator_strength": "200; 10"
}

Related drugs

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