laxative

Generic: bisacodyl

Labeler: hhh pharma usa llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name laxative
Generic Name bisacodyl
Labeler hhh pharma usa llc
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

bisacodyl 5 mg/1

Manufacturer
HHH PHARMA USA LLC

Identifiers & Regulatory

Product NDC 83586-116
Product ID 83586-116_3af84a56-99e2-7869-e063-6294a90accda
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number 505G(a)(3)
Listing Expiration 2026-12-31
Marketing Start 2025-07-28

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 83586116
Hyphenated Format 83586-116

Supplemental Identifiers

RxCUI
308753
UPC
0383586116014
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 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 (83586-116-01)
source: ndc

Packages (1)

83586-116-01 100 TABLET, DELAYED RELEASE in 1 BOTTLE (83586-116-01)

Ingredients (1)

bisacodyl (5 mg/1)

Linked Drug Pages (1)

Laxative ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3af84a56-99e2-7869-e063-6294a90accda", "openfda": {"nui": ["N0000009371", "N0000175812", "N0000009871"], "upc": ["0383586116014"], "unii": ["10X0709Y6I"], "rxcui": ["308753"], "spl_set_id": ["afb39544-c509-490c-ad42-ba68ebbf986b"], "pharm_class_pe": ["Increased Large Intestinal Motility [PE]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "pharm_class_epc": ["Stimulant Laxative [EPC]"], "manufacturer_name": ["HHH PHARMA USA LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, DELAYED RELEASE in 1 BOTTLE (83586-116-01)", "package_ndc": "83586-116-01", "marketing_start_date": "20250728"}], "brand_name": "Laxative", "product_id": "83586-116_3af84a56-99e2-7869-e063-6294a90accda", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Increased Large Intestinal Motility [PE]", "Stimulant Laxative [EPC]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "83586-116", "generic_name": "Bisacodyl", "labeler_name": "HHH PHARMA USA LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Laxative", "active_ingredients": [{"name": "BISACODYL", "strength": "5 mg/1"}], "application_number": "505G(a)(3)", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250728", "listing_expiration_date": "20261231"}