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United States · US · US:67751-120_f70c1b68-61c9-b333-e053-6294a90aadaa

Motrin IB

Orange BookUNIISPLATC G02CC01

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

Identification

ManufacturerNavajo Manufacturing Company Inc.
CountryUS (United States)
ATC codeG02CC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6775112001
    1 POUCH in 1 CARTON (67751-120-01) / 2 TABLET, FILM COATED in 1 POUCH
  • ndc11
    6775112002
    2 POUCH in 1 CARTON (67751-120-02) / 2 TABLET, FILM COATED in 1 POUCH

Annotations

UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
N019012
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": {
    "c57f6ded-c0bd-45ae-823a-4c02ce334d98": {
      "match": "brand_token",
      "title": "MOTRIN INFANTS (IBUPROFEN) SUSPENSION/ DROPS [KENVUE BRANDS LLC]",
      "spl_version": "17",
      "published_date": "2026-05-20"
    }
  },
  "productid": "67751-120_f70c1b68-61c9-b333-e053-6294a90aadaa",
  "productndc": "67751-120",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "019012",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "May 18, 1984"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "200MG",
        "product_no": "002",
        "approval_date": "Jul 29, 1987"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "200MG",
        "product_no": "003",
        "approval_date": "Dec 17, 1990"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "200MG",
        "product_no": "004",
        "approval_date": "Feb 25, 2000"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "IBUPROFEN",
  "proprietary_name": "Motrin IB",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA019012",
  "marketing_category": "NDA",
  "nonproprietary_name": "IBUPROFEN",
  "start_marketing_date": "20160922",
  "active_numerator_strength": "200"
}

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