Polyethylene Glycol 3350

Orange BookUNIISPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAurohealth LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
5860280501
119 g in 1 BOTTLE, PLASTIC (58602-805-01)
ndc11
5860280502
238 g in 1 BOTTLE, PLASTIC (58602-805-02)
ndc11
5860280503
510 g in 1 BOTTLE, PLASTIC (58602-805-03)
ndc11
5860280504
850 g in 1 BOTTLE, PLASTIC (58602-805-04)
ndc11
5860280525
765 g in 1 BOTTLE, PLASTIC (58602-805-25)
ndc11
5860280527
14 PACKET in 1 CARTON (58602-805-27) / 17 g in 1 PACKET

Annotations

UNII (FDA Substance ID)

G2M7P15E5P

POLYETHYLENE GLYCOL 3350

RxCUI 221147

Orange Book

A209017

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": {
    "ddc9d2b1-87d8-44fa-bac6-0a7261f33564": {
      "match": "brand_token",
      "title": "POLYETHYLENE GLYCOL 3350 POWDER, FOR SOLUTION [MAJOR PHARMACEUTICALS]",
      "spl_version": "11",
      "published_date": "2026-05-25"
    }
  },
  "productid": "58602-805_af3011d1-9e74-42f2-bbc8-8f08c45898ea",
  "productndc": "58602-805",
  "dosage_form": "POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "209017",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "17GM/SCOOPFUL",
        "product_no": "001",
        "approval_date": "Apr 9, 2018"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "17GM/PACKET",
        "product_no": "002",
        "approval_date": "Apr 23, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "POLYETHYLENE GLYCOL 3350",
  "proprietary_name": "Polyethylene Glycol 3350",
  "active_ingred_unit": "g/17g",
  "application_number": "ANDA209017",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Polyethylene Glycol 3350",
  "start_marketing_date": "20180409",
  "active_numerator_strength": "17"
}

Access this data programmatically

Query Polyethylene Glycol 3350 and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs