Home NDC 85631-015 STOMACH-SOOTHING FORMULA
Product NDC 85631-015
11-digit product format 856310015
Labeler code 85631
Product ID 85631-015_4671e562-3d97-32ec-e063-6294a90ab53a
Type HUMAN OTC DRUG
Nonproprietary name REISHI YEAST FU LING OPHIOPOGON JAPONICUS WHOLE
Dosage form CAPSULE
Route ORAL
Labeler Bispit Canada Ltd.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2025-12-22
Substance YEAST; OPHIOPOGON JAPONICUS WHOLE; REISHI; FU LING
Active strength 3; 4.5; 50; 5 g/100g; g/100g; g/100g; g/100g
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
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 STOMACH-SOOTHING FORMULA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength YEAST 3 g/100g OPHIOPOGON JAPONICUS WHOLE 4.5 g/100g REISHI 50 g/100g FU LING 5 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85631-015-01 STOMACH-SOOTHING FORMULA 90 in 1 BOTTLE CAPSULE 90 1 85631-015-01 STOMACH-SOOTHING FORMULA 0.8 g in 1 CAPSULE CAPSULE 0.8 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 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85631-015-01 85631001501 90 CAPSULE in 1 BOTTLE (85631-015-01) / .8 g in 1 CAPSULE 90 capsule 2025-12-22 No No Current