topcare clearlax

Generic: polyethylene glycol 3350

Labeler: topco associates llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name topcare clearlax
Generic Name polyethylene glycol 3350
Labeler topco associates llc
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

polyethylene glycol 3350 17 g/17g

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 76162-119
Product ID 76162-119_57254ac5-729d-4aae-863d-b57a67053aec
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA090685
Listing Expiration 2026-12-31
Marketing Start 2024-01-30

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 76162119
Hyphenated Format 76162-119

Supplemental Identifiers

RxCUI
876193 880407
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 topcare clearlax (source: ndc)
Generic Name polyethylene glycol 3350 (source: ndc)
Application Number ANDA090685 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 17 g/17g
source: ndc
Packaging
  • 238 g in 1 BOTTLE (76162-119-02)
source: ndc

Packages (1)

76162-119-02 238 g in 1 BOTTLE (76162-119-02)

Ingredients (1)

polyethylene glycol 3350 (17 g/17g)

Linked Drug Pages (1)

Topcare ClearLax ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "57254ac5-729d-4aae-863d-b57a67053aec", "openfda": {"nui": ["N0000010288", "N0000175811", "N0000009871"], "unii": ["G2M7P15E5P"], "rxcui": ["876193", "880407"], "spl_set_id": ["02f81a86-bec5-4e8b-bddb-d463ae2ea9e9"], "pharm_class_pe": ["Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "pharm_class_epc": ["Osmotic Laxative [EPC]"], "pharm_class_moa": ["Osmotic Activity [MoA]"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "238 g in 1 BOTTLE (76162-119-02)", "package_ndc": "76162-119-02", "marketing_start_date": "20240130"}], "brand_name": "Topcare ClearLax", "product_id": "76162-119_57254ac5-729d-4aae-863d-b57a67053aec", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Osmotic Activity [MoA]", "Osmotic Laxative [EPC]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "76162-119", "generic_name": "Polyethylene Glycol 3350", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Topcare ClearLax", "active_ingredients": [{"name": "POLYETHYLENE GLYCOL 3350", "strength": "17 g/17g"}], "application_number": "ANDA090685", "marketing_category": "ANDA", "marketing_start_date": "20240130", "listing_expiration_date": "20261231"}