NDC 0597-0165

DulcoGas

Simethicone

DulcoGas is a Oral Tablet, Chewable in the Human Otc Drug category. It is labeled and distributed by Boehringer Ingelheim Pharmaceuticals, Inc.. The primary component is Dimethicone.

• Product ID: 0597-0165_a16ccb30-ea57-b5fa-985c-cc0fe546d19d
• NDC: 0597-0165
• Product Type: Human Otc Drug
• Proprietary Name: DulcoGas
• Generic Name: Simethicone
• Dosage Form: Tablet, Chewable
• Route of Administration: ORAL
• Marketing Start Date: 2014-02-28
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part332
• Labeler Name: Boehringer Ingelheim Pharmaceuticals, Inc.
• Substance Name: DIMETHICONE
• Active Ingredient Strength: 125 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0597-0165-37

5 BLISTER PACK in 1 CARTON (0597-0165-37) > 6 TABLET, CHEWABLE in 1 BLISTER PACK

• Marketing Start Date: 2014-02-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0597-0165-88 [00597016588]

DulcoGas TABLET, CHEWABLE

• Marketing Category: OTC monograph final
• Application Number: part332
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2014-02-28

NDC 0597-0165-37 [00597016537]

DulcoGas TABLET, CHEWABLE

• Marketing Category: OTC monograph final
• Application Number: part332
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2014-02-28

NDC 0597-0165-36 [00597016536]

DulcoGas TABLET, CHEWABLE

• Marketing Category: OTC monograph final
• Application Number: part332
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2014-02-28
• Marketing End Date: 2015-11-30

Drug Details

Active Ingredients

Ingredient	Strength
DIMETHICONE	125 mg/1

OpenFDA Data

• SPL SET ID: 9fbe496c-1aca-8846-5407-56018981c0b4
• Manufacturer:
  • Boehringer Ingelheim Pharmaceuticals, Inc.
• UNII:
  • 92RU3N3Y1O
• RxNorm Concept Unique ID - RxCUI:
  • 1545652
  • 314221

NDC Crossover Matching brand name "DulcoGas" or generic name "Simethicone"

NDC	Brand Name	Generic Name
0597-0186	DulcoGas	DulcoGas
0597-0170	DulcoGas	DulcoGas
0597-0165	DulcoGas	DulcoGas
0363-0608	Extra Strength Gas Relief	Simethicone
0363-0125	Gas Relief	Simethicone
0363-0487	Gas Relief	SIMETHICONE
0363-0530	Gas Relief	Simethicone
0363-0635	Gas Relief	Simethicone
0067-0116	Gas-X	Simethicone
0067-0117	Gas-X	Simethicone
0067-0129	Gas-X	Simethicone
0067-0134	Gas-X	Simethicone
0067-6274	Gas-X	Simethicone
0067-6275	Gas-X	Simethicone
0067-6283	Gas-X	Simethicone
0113-0428	Good Sense Gas Relief	Simethicone
0113-0657	good sense gas relief	Simethicone
0113-0882	good sense simethicone	Simethicone
0113-6011	injoy gas relief	Simethicone
0132-0208	PHAZYME	Simethicone
0132-0211	PHAZYME	Simethicone
0132-0214	PHAZYME	Simethicone
0132-0215	PHAZYME	Simethicone
0132-0217	PHAZYME ULTIMATE	SIMETHICONE
0363-0118	Walgreens	Simethicone