NDC 37000-538

Pepto Diarrhea

Bismuth Subsalicylate

Pepto Diarrhea is a Oral Suspension in the Human Otc Drug category. It is labeled and distributed by The Procter & Gamble Manufacturing Company. The primary component is Bismuth Subsalicylate.

• Product ID: 37000-538_8517f38b-b901-84f2-e053-2991aa0abab0
• NDC: 37000-538
• Product Type: Human Otc Drug
• Proprietary Name: Pepto Diarrhea
• Generic Name: Bismuth Subsalicylate
• Dosage Form: Suspension
• Route of Administration: ORAL
• Marketing Start Date: 2018-03-01
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part335
• Labeler Name: The Procter & Gamble Manufacturing Company
• Substance Name: BISMUTH SUBSALICYLATE
• Active Ingredient Strength: 525 mg/30mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 37000-538-04

118 mL in 1 BOTTLE, PLASTIC (37000-538-04)

• Marketing Start Date: 2019-03-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 37000-538-04 [37000053804]

Pepto Diarrhea SUSPENSION

• Marketing Category: OTC monograph final
• Application Number: part335
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2019-03-01

Drug Details

Active Ingredients

Ingredient	Strength
BISMUTH SUBSALICYLATE	525 mg/30mL

OpenFDA Data

• SPL SET ID: 8517edac-fda7-7a49-e053-2a91aa0a24cd
• Manufacturer:
  • The Procter & Gamble Manufacturing Company
• UNII:
  • 62TEY51RR1

NDC Crossover Matching brand name "Pepto Diarrhea" or generic name "Bismuth Subsalicylate"

NDC	Brand Name	Generic Name
37000-538	Pepto Diarrhea	Pepto Diarrhea
0113-7469	basic care stomach relief	Bismuth subsalicylate
0904-1313	Bismatrol	Bismuth Subsalicylate
0904-1314	Bismatrol	Bismuth Subsalicylate
0536-4301	Bismuth subsalicylate	Bismuth subsalicylate
0113-0302	Good Sense Stomach Relief	Bismuth subsalicylate
0113-0337	Good Sense Stomach Relief	bismuth subsalicylate
0113-0469	good sense stomach relief	Bismuth subsalicylate
0322-2222	Percy Medicine	Bismuth Subsalicylate
0121-4803	Pink Bismuth	Bismuth Subsalicylate
0536-1810	PINK BISMUTH	bismuth subsalicylate
0363-0025	Soothe	Bismuth subsalicylate
0363-0073	Soothe	Bismuth subsalicylate
0363-0319	Soothe	BISMUTH SUBSALICYLATE
0363-0346	Soothe	Bismuth Subsalicylate
0363-0371	Soothe	Bismuth subsalicylate
0363-0736	Soothe	Bismuth subsalicylate
0363-7240	Soothe	Bismuth subsalicylate
0363-7370	Soothe	Bismuth subsalicylate
0121-0910	Stomach Relief	Bismuth subsalicylate
0536-1286	Stomach Relief	Bismuth subsalicylate
0536-1287	Stomach Relief	Bismuth subsalicylate
0363-1302	Ultra Strength digestive relief	Bismuth subsalicylate
0363-9124	Walgreen	Bismuth Subsalicylate
0363-9125	Walgreen	Bismuth Subsalicylate