NDC 0597-0162

Dulcolax

Bisacodyl

Dulcolax is a Rectal Suppository in the Human Otc Drug category. It is labeled and distributed by Boehringer Ingelheim Pharmaceuticals, Inc.. The primary component is Bisacodyl.

• Product ID: 0597-0162_b4c52ddb-75bf-e6c4-bc20-864fff38a7f2
• NDC: 0597-0162
• Product Type: Human Otc Drug
• Proprietary Name: Dulcolax
• Generic Name: Bisacodyl
• Dosage Form: Suppository
• Route of Administration: RECTAL
• Marketing Start Date: 2013-08-05
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part334
• Labeler Name: Boehringer Ingelheim Pharmaceuticals, Inc.
• Substance Name: BISACODYL
• Active Ingredient Strength: 10 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0597-0162-03

1 BLISTER PACK in 1 CARTON (0597-0162-03) > 5 SUPPOSITORY in 1 BLISTER PACK

• Marketing Start Date: 2013-08-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0597-0162-03 [00597016203]

Dulcolax SUPPOSITORY

• Marketing Category: OTC monograph not final
• Application Number: part334
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2013-08-05

Drug Details

Active Ingredients

Ingredient	Strength
BISACODYL	10 mg/1

OpenFDA Data

• SPL SET ID: 8459ee71-64eb-daba-d73d-b6ee37b945d1
• Manufacturer:
  • Boehringer Ingelheim Pharmaceuticals, Inc.
• UNII:
  • 10X0709Y6I
• RxNorm Concept Unique ID - RxCUI:
  • 198509
  • 209601
• Pharm Class PE:
  • Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
  • Increased Large Intestinal Motility [PE]
• PHarm Class EPC:
  • Stimulant Laxative [EPC]
• NUI Code:
  • N0000009371
  • N0000175812
  • N0000009871

NDC Crossover Matching brand name "Dulcolax" or generic name "Bisacodyl"

NDC	Brand Name	Generic Name
0597-0012	Dulcolax	bisacodyl
0597-0016	Dulcolax	Docusate sodium
0597-0052	Dulcolax	Bisacodyl
0597-0162	Dulcolax	Bisacodyl
0597-0340	Dulcolax	bisacodyl
29485-6741	Dulcolax	Dulcolax
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
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