gentle laxative

Generic: bisacodyl

Labeler: l.n.k. international, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name gentle laxative
Generic Name bisacodyl
Labeler l.n.k. international, inc.
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

bisacodyl 5 mg/1

Manufacturer
L.N.K. International, Inc.

Identifiers & Regulatory

Product NDC 50844-327
Product ID 50844-327_edf539ac-a31f-4c17-8d15-d003822d326a
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number 505G(a)(3)
Listing Expiration 2026-12-31
Marketing Start 2002-03-25

Pharmacologic Class

Established (EPC)
stimulant laxative [epc]
Physiologic Effect
increased large intestinal motility [pe] stimulation large intestine fluid/electrolyte secretion [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50844327
Hyphenated Format 50844-327

Supplemental Identifiers

RxCUI
308753
UPC
0350844327154
UNII
10X0709Y6I
NUI
N0000009371 N0000175812 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 gentle laxative (source: ndc)
Generic Name bisacodyl (source: ndc)
Application Number 505G(a)(3) (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (50844-327-12)
  • 2 BLISTER PACK in 1 CARTON (50844-327-15) / 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (50844-327-56) / 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK
source: ndc

Packages (3)

50844-327-12 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (50844-327-12) 50844-327-15 2 BLISTER PACK in 1 CARTON (50844-327-15) / 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK 50844-327-56 1 BLISTER PACK in 1 CARTON (50844-327-56) / 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK

Ingredients (1)

bisacodyl (5 mg/1)

Linked Drug Pages (1)

Gentle Laxative ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "edf539ac-a31f-4c17-8d15-d003822d326a", "openfda": {"nui": ["N0000009371", "N0000175812", "N0000009871"], "upc": ["0350844327154"], "unii": ["10X0709Y6I"], "rxcui": ["308753"], "spl_set_id": ["c4ff36f2-6cdc-4d8a-a268-2919745047db"], "pharm_class_pe": ["Increased Large Intestinal Motility [PE]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "pharm_class_epc": ["Stimulant Laxative [EPC]"], "manufacturer_name": ["L.N.K. International, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (50844-327-12)", "package_ndc": "50844-327-12", "marketing_start_date": "20020325"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (50844-327-15)  / 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "50844-327-15", "marketing_start_date": "20020325"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (50844-327-56)  / 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "50844-327-56", "marketing_start_date": "20020325"}], "brand_name": "Gentle Laxative", "product_id": "50844-327_edf539ac-a31f-4c17-8d15-d003822d326a", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Increased Large Intestinal Motility [PE]", "Stimulant Laxative [EPC]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "50844-327", "generic_name": "Bisacodyl", "labeler_name": "L.N.K. International, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Gentle Laxative", "active_ingredients": [{"name": "BISACODYL", "strength": "5 mg/1"}], "application_number": "505G(a)(3)", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20020325", "listing_expiration_date": "20261231"}