Home NDC 85786-802-12 Dr. Simi Stomach Relief
Product NDC 85786-802
Requested package NDC 85786-802-12
11-digit product format 857860802
Labeler code 85786
Product ID 85786-802_4dc9233e-68fc-e1e8-e063-6294a90aee33
Type HUMAN OTC DRUG
Nonproprietary name BISMUTH SUBSALICYLATE 525 MG
Dosage form SUSPENSION
Route ORAL
Labeler Farmacias De Similares TX LLC
Application M008
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-03-24
Substance BISMUTH SUBSALICYLATE
Active strength 525 mg/30mL
Pharmacologic classes Bismuth [CS], Bismuth [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Dr. Simi Stomach Relief
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BISMUTH SUBSALICYLATE 525 mg/30mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 62TEY51RR1 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308762 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85786-802-12 Dr. Simi Stomach Relief 354 mL in 1 BOTTLE SUSPENSION 354 1
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 12 · 223 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85786-802-12 85786080212 354 mL in 1 BOTTLE (85786-802-12) 354 ml 2026-03-24 No No Current