gentle laxative

Generic: bisacodyl

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

Drug Facts

Product Profile

Brand Name gentle laxative
Generic Name bisacodyl
Labeler topco associates, llc
Dosage Form TABLET, DELAYED RELEASE
Routes
ORAL
Active Ingredients

bisacodyl 5 mg/1

Manufacturer
Topco Associates, LLC

Identifiers & Regulatory

Product NDC 36800-327
Product ID 36800-327_df99a712-9045-45e4-9188-46b1f1f441d3
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number 505G(a)(3)
Listing Expiration 2027-12-31
Marketing Start 2019-05-15

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 36800327
Hyphenated Format 36800-327

Supplemental Identifiers

UPC
0036800461154
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
  • 1 BLISTER PACK in 1 CARTON (36800-327-03) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (36800-327-56) / 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK
source: ndc

Packages (2)

36800-327-03 1 BLISTER PACK in 1 CARTON (36800-327-03) / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK 36800-327-56 1 BLISTER PACK in 1 CARTON (36800-327-56) / 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": "df99a712-9045-45e4-9188-46b1f1f441d3", "openfda": {"nui": ["N0000009371", "N0000175812", "N0000009871"], "upc": ["0036800461154"], "unii": ["10X0709Y6I"], "spl_set_id": ["e4ff1277-b859-4c34-872f-0dc5b7879121"], "pharm_class_pe": ["Increased Large Intestinal Motility [PE]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "pharm_class_epc": ["Stimulant Laxative [EPC]"], "manufacturer_name": ["Topco Associates, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (36800-327-03)  / 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "36800-327-03", "marketing_start_date": "20190515"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (36800-327-56)  / 25 TABLET, DELAYED RELEASE in 1 BLISTER PACK", "package_ndc": "36800-327-56", "marketing_start_date": "20190515"}], "brand_name": "Gentle Laxative", "product_id": "36800-327_df99a712-9045-45e4-9188-46b1f1f441d3", "dosage_form": "TABLET, DELAYED RELEASE", "pharm_class": ["Increased Large Intestinal Motility [PE]", "Stimulant Laxative [EPC]", "Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]"], "product_ndc": "36800-327", "generic_name": "Bisacodyl", "labeler_name": "Topco Associates, LLC", "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": "20190515", "listing_expiration_date": "20271231"}