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United States · US · US:41167-0223_ac5d744b-7090-4649-97b8-352d61425b09

Dulcolax

Orange BookUNIISPL

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

Identification

ManufacturerChattem, Inc.
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4116702230
    765 g in 1 BOTTLE (41167-0223-0)

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": {
    "fe71907c-b1eb-4433-9337-933a944f3e62": {
      "match": "brand_token",
      "title": "DULCOLAX SOFT CHEWS MIXED BERRY (MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [CHATTEM, INC.]",
      "spl_version": "9",
      "published_date": "2026-03-30"
    }
  },
  "productid": "41167-0223_ac5d744b-7090-4649-97b8-352d61425b09",
  "productndc": "41167-0223",
  "dosage_form": "POWDER",
  "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": "Dulcolax",
  "active_ingred_unit": "g/17g",
  "application_number": "ANDA090685",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Polyethylene glycol 3350",
  "start_marketing_date": "20250930",
  "active_numerator_strength": "17"
}

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