NDC 36800-808

TopCare Gentle Laxative

Bisacodyl

TopCare Gentle Laxative is a Rectal Suppository in the Human Otc Drug category. It is labeled and distributed by Topco Associates Llc. The primary component is Bisacodyl.

• Product ID: 36800-808_e64fc896-056a-4ab3-80db-e07559e21301
• NDC: 36800-808
• Product Type: Human Otc Drug
• Proprietary Name: TopCare Gentle Laxative
• Generic Name: Bisacodyl
• Dosage Form: Suppository
• Route of Administration: RECTAL
• Marketing Start Date: 2015-02-13
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part334
• Labeler Name: Topco Associates LLC
• Substance Name: BISACODYL
• Active Ingredient Strength: 10 mg/2000mg
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 36800-808-08

2 BLISTER PACK in 1 CARTON (36800-808-08) > 40 mg in 1 BLISTER PACK

• Marketing Start Date: 2015-11-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 36800-808-08 [36800080808]

TopCare Gentle Laxative SUPPOSITORY

• Marketing Category: OTC monograph not final
• Application Number: part334
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2015-11-16
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
BISACODYL	10 mg/2000mg

OpenFDA Data

• SPL SET ID: 11eeb713-4f7d-4965-b12b-6798b23b96f6
• Manufacturer:
  • Topco Associates LLC
• UNII:
  • 10X0709Y6I
• RxNorm Concept Unique ID - RxCUI:
  • 198509
• Pharm Class PE:
  • Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
  • Increased Large Intestinal Motility [PE]
• PHarm Class EPC:
  • Stimulant Laxative [EPC]
• UPC Code:
  • 0036800160439
• NUI Code:
  • N0000009371
  • N0000175812
  • N0000009871

NDC Crossover Matching brand name "TopCare Gentle Laxative" or generic name "Bisacodyl"

NDC	Brand Name	Generic Name
36800-808	TopCare Gentle Laxative	TopCare Gentle Laxative
0713-0109	BISAC-EVAC	Bisacodyl
0574-7050	Bisacodyl	bisacodyl
0904-6748	Bisacodyl	Bisacodyl
0904-7142	Bisacodyl	Bisacodyl
0904-7927	Bisacodyl	Bisacodyl
0536-1355	Biscolax	Bisacodyl
0904-5058	Biscolax Laxative	Bisacodyl
10237-906	Carters Little Pills	Bisacodyl
0597-0012	Dulcolax	bisacodyl
0597-0052	Dulcolax	Bisacodyl
0597-0162	Dulcolax	Bisacodyl
0597-0340	Dulcolax	bisacodyl
0597-0051	Dulcolax Pink	bisacodyl
0597-0169	Dulcolax Pink	bisacodyl
0597-0335	Dulcolax Pink	bisacodyl
0536-3381	Enteric Coated Stimulant Laxative	Bisacodyl
0132-0703	Fleet	Bisacodyl
0363-0327	Gentle Laxative	Bisacodyl
0363-6760	Laxative	Bisacodyl
0904-6407	Unit Dose Bisacodyl	Bisacodyl
0363-3011	WOMENS GENTLE LAXATIVE	BISACODYL
0363-0676	Womens laxative	Bisacodyl