Home NDC 37000-691-30 Pepto-Bismol
Product NDC 37000-691
Requested package NDC 37000-691-30
11-digit product format 370000691
Labeler code 37000
Product ID 37000-691_99d74431-4fcc-766b-e053-2995a90a1dd9
Type HUMAN OTC DRUG
Nonproprietary name Bismuth Subsalicylate
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler The Procter & Gamble Manufacturing Company
Application part335
Marketing category OTC MONOGRAPH FINAL
Marketing start 2009-07-09
Marketing end 2021-12-01
Substance BISMUTH SUBSALICYLATE
Active strength 262 mg/1
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Bismuth Subsalicylate ACTIVE INGREDIENT 62TEY51RR1 PEPTO-BISMOL INSTACOOL (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [THE PROCTER & GAMBLE MANUFACTURING COMPANY] 5 Salicylic Acid ACTIVE MOIETY O414PZ4LPZ PEPTO-BISMOL INSTACOOL (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [THE PROCTER & GAMBLE MANUFACTURING COMPANY] 5 aluminum oxide INACTIVE INGREDIENT LMI26O6933 PEPTO-BISMOL INSTACOOL (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [THE PROCTER & GAMBLE MANUFACTURING COMPANY] 5 calcium carbonate INACTIVE INGREDIENT H0G9379FGK PEPTO-BISMOL INSTACOOL (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [THE PROCTER & GAMBLE MANUFACTURING COMPANY] 5 D&C red no. 27 INACTIVE INGREDIENT 2LRS185U6K PEPTO-BISMOL INSTACOOL (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [THE PROCTER & GAMBLE MANUFACTURING COMPANY] 5 magnesium stearate INACTIVE INGREDIENT 70097M6I30 PEPTO-BISMOL INSTACOOL (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [THE PROCTER & GAMBLE MANUFACTURING COMPANY] 5 mannitol INACTIVE INGREDIENT 3OWL53L36A PEPTO-BISMOL INSTACOOL (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [THE PROCTER & GAMBLE MANUFACTURING COMPANY] 5 povidones INACTIVE INGREDIENT FZ989GH94E PEPTO-BISMOL INSTACOOL (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [THE PROCTER & GAMBLE MANUFACTURING COMPANY] 5 saccharin sodium INACTIVE INGREDIENT SB8ZUX40TY PEPTO-BISMOL INSTACOOL (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [THE PROCTER & GAMBLE MANUFACTURING COMPANY] 5 talc INACTIVE INGREDIENT 7SEV7J4R1U PEPTO-BISMOL INSTACOOL (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [THE PROCTER & GAMBLE MANUFACTURING COMPANY] 5 Bismuth Subsalicylate ACTIVE INGREDIENT 62TEY51RR1 PEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY] 2 Salicylic Acid ACTIVE MOIETY O414PZ4LPZ PEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY] 2 aluminum oxide INACTIVE INGREDIENT LMI26O6933 PEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY] 2 benzoic acid INACTIVE INGREDIENT 8SKN0B0MIM PEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY] 2 calcium carbonate INACTIVE INGREDIENT H0G9379FGK PEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY] 2 D&C Red No. 22 INACTIVE INGREDIENT 1678RKX8RT PEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY] 2 D&C Red No. 27 INACTIVE INGREDIENT 2LRS185U6K PEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY] 2 D&C Red No. 28 INACTIVE INGREDIENT 767IP0Y5NH PEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY] 2 magnesium aluminum silicate INACTIVE INGREDIENT 6M3P64V0NC PEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY] 2 magnesium stearate INACTIVE INGREDIENT 70097M6I30 PEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY] 2 mannitol INACTIVE INGREDIENT 3OWL53L36A PEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY] 2 povidones INACTIVE INGREDIENT FZ989GH94E PEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY] 2 saccharin sodium INACTIVE INGREDIENT SB8ZUX40TY PEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY] 2 salicylic acid INACTIVE INGREDIENT O414PZ4LPZ PEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY] 2 sodium salicylate INACTIVE INGREDIENT WIQ1H85SYP PEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY] 2 sorbic acid INACTIVE INGREDIENT X045WJ989B PEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY] 2 talc INACTIVE INGREDIENT 7SEV7J4R1U PEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY] 2 water INACTIVE INGREDIENT 059QF0KO0R PEPTO-BISMOL (BISMUTH SUBSALICYLATE) KIT [PROCTER & GAMBLE MANUFACTURING COMPANY] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 37000-691-30 37000069130 1 BOTTLE, PLASTIC in 1 CARTON (37000-691-30) > 30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC 2009-07-09 2021-12-01 No No Current