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United States · US · US:68094-600_df2a68e8-8400-4e49-ba13-bd66284bec52

Dye Free Childrens Ibuprofen

Orange BookUNIISPLATC G02CC01

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

Identification

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

Packs · 2

  • ndc11
    6809460061
    10 TRAY in 1 CASE (68094-600-61) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-600-59)
  • ndc11
    6809460062
    3 TRAY in 1 CASE (68094-600-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-600-59)

Annotations

UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A074937
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": {
    "46846abe-062d-a11f-e063-6294a90a73f3": {
      "match": "brand_token",
      "title": "DYE FREE REGULAR STRENGTH STOMACH RELIEF (BISMUTH SUBSALICYLATE) SUSPENSION [WALMART INC.]",
      "spl_version": "2",
      "published_date": "2026-02-26"
    }
  },
  "productid": "68094-600_df2a68e8-8400-4e49-ba13-bd66284bec52",
  "productndc": "68094-600",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "074937",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "100MG/5ML",
        "product_no": "001",
        "approval_date": "Dec 22, 1998"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "IBUPROFEN",
  "proprietary_name": "Dye Free Childrens Ibuprofen",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA074937",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ibuprofen",
  "start_marketing_date": "20150826",
  "active_numerator_strength": "100"
}

Related drugs

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