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United States · US · US:30142-504_e1f2a9bc-4f0c-4bf3-847f-e8a806c6856f

GENTLELAX

Orange BookUNIISPL

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

Identification

ManufacturerKroger Company
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    3014250402
    238 g in 1 CONTAINER (30142-504-02)

Annotations

UNII (FDA Substance ID)
G2M7P15E5P
POLYETHYLENE GLYCOL 3350
RxCUI 221147
Orange Book
A090685
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "G2M7P15E5P",
    "rxcui": "221147",
    "inchikey": null,
    "display_name": "POLYETHYLENE GLYCOL 3350",
    "substance_type": "polymer",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "2390b507-93d5-43a0-aa51-31ca4edd6b7f": {
      "match": "brand_token",
      "title": "GENTLELAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [KROGER COMPANY]",
      "spl_version": "2",
      "published_date": "2024-07-08"
    }
  },
  "productid": "30142-504_e1f2a9bc-4f0c-4bf3-847f-e8a806c6856f",
  "productndc": "30142-504",
  "dosage_form": "POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "090685",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "17GM/PACKET",
        "product_no": "001",
        "approval_date": "Oct 6, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "17GM/SCOOPFUL",
        "product_no": "002",
        "approval_date": "Oct 6, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "POLYETHYLENE GLYCOL 3350",
  "proprietary_name": "GENTLELAX",
  "active_ingred_unit": "g/17g",
  "application_number": "ANDA090685",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Polyethylene Glycol 3350",
  "start_marketing_date": "20240620",
  "active_numerator_strength": "17"
}

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