comfortlax

Generic: polyethylene glycol 3350

Labeler: family dollar stores, llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name comfortlax
Generic Name polyethylene glycol 3350
Labeler family dollar stores, llc
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

polyethylene glycol 3350 17 g/17g

Manufacturer
Family Dollar Stores, LLC

Identifiers & Regulatory

Product NDC 55319-056
Product ID 55319-056_984fa376-5393-4165-89a9-ac0d1b617c35
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA209017
Listing Expiration 2026-12-31
Marketing Start 2024-09-04

Pharmacologic Class

Established (EPC)
osmotic laxative [epc]
Mechanism of Action
osmotic activity [moa]
Physiologic Effect
stimulation large intestine fluid/electrolyte secretion [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55319056
Hyphenated Format 55319-056

Supplemental Identifiers

RxCUI
876193 2695451
UPC
0032251948893
UNII
G2M7P15E5P
NUI
N0000010288 N0000175811 N0000009871

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name comfortlax (source: ndc)
Generic Name polyethylene glycol 3350 (source: ndc)
Application Number ANDA209017 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 17 g/17g
source: ndc
Packaging
  • 119 g in 1 BOTTLE, PLASTIC (55319-056-24)
  • 510 g in 1 BOTTLE, PLASTIC (55319-056-27)
  • 238 g in 1 BOTTLE, PLASTIC (55319-056-33)
source: ndc

Packages (3)

55319-056-24 119 g in 1 BOTTLE, PLASTIC (55319-056-24) 55319-056-27 510 g in 1 BOTTLE, PLASTIC (55319-056-27) 55319-056-33 238 g in 1 BOTTLE, PLASTIC (55319-056-33)

Ingredients (1)

polyethylene glycol 3350 (17 g/17g)

Linked Drug Pages (1)

COMFORTLAX ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "984fa376-5393-4165-89a9-ac0d1b617c35", "openfda": {"nui": ["N0000010288", "N0000175811", "N0000009871"], "upc": ["0032251948893"], "unii": ["G2M7P15E5P"], "rxcui": ["876193", "2695451"], "spl_set_id": ["02a44a41-0039-f6ec-e063-6394a90ae6f1"], "pharm_class_pe": ["Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "pharm_class_epc": ["Osmotic Laxative [EPC]"], "pharm_class_moa": ["Osmotic Activity [MoA]"], "manufacturer_name": ["Family Dollar Stores, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "119 g in 1 BOTTLE, PLASTIC (55319-056-24)", "package_ndc": "55319-056-24", "marketing_start_date": "20240904"}, {"sample": false, "description": "510 g in 1 BOTTLE, PLASTIC (55319-056-27)", "package_ndc": "55319-056-27", "marketing_start_date": "20240904"}, {"sample": false, "description": "238 g in 1 BOTTLE, PLASTIC (55319-056-33)", "package_ndc": "55319-056-33", "marketing_start_date": "20240904"}], "brand_name": "COMFORTLAX", "product_id": "55319-056_984fa376-5393-4165-89a9-ac0d1b617c35", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "55319-056", "generic_name": "Polyethylene Glycol 3350", "labeler_name": "Family Dollar Stores, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "COMFORTLAX", "active_ingredients": [{"name": "POLYETHYLENE GLYCOL 3350", "strength": "17 g/17g"}], "application_number": "ANDA209017", "marketing_category": "ANDA", "marketing_start_date": "20240904", "listing_expiration_date": "20261231"}