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United States · US · US:67751-150_f6f7501a-9ba4-82ea-e053-6294a90a298e

Advil Sinus Congestion and Pain Relief

Orange BookUNIISPLATC C01EB

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

Identification

ManufacturerNavajo Manufacturing Company Inc.
CountryUS (United States)
ATC codeC01EB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6775115001
    1 POUCH in 1 CARTON (67751-150-01) / 1 TABLET, COATED in 1 POUCH
  • ndc11
    6775115002
    1 POUCH in 1 CARTON (67751-150-02) / 2 TABLET, COATED in 1 POUCH

Annotations

UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
N022565
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": {
    "a3c30dd2-75f3-4f8b-88d7-4a63dea5bad7": {
      "match": "brand_token",
      "title": "ADVIL PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [NAVAJO MANUFACTURING COMPANY INC.]",
      "spl_version": "3",
      "published_date": "2026-04-09"
    }
  },
  "productid": "67751-150_f6f7501a-9ba4-82ea-e053-6294a90a298e",
  "productndc": "67751-150",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "022565",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "200MG;10MG",
        "product_no": "001",
        "approval_date": "May 27, 2010"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE",
  "proprietary_name": "Advil Sinus Congestion and Pain Relief",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA022565",
  "marketing_category": "NDA",
  "nonproprietary_name": "IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDE",
  "start_marketing_date": "20160920",
  "active_numerator_strength": "200; 10"
}

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