Home NDC 85631-011-01 Pulmonary Nodule
Product NDC 85631-011
Requested package NDC 85631-011-01
11-digit product format 856310011
Labeler code 85631
Product ID 85631-011_42af8bf8-80b5-e1a1-e063-6394a90a306c
Type HUMAN OTC DRUG
Nonproprietary name Pulmonary Nodule
Dosage form CAPSULE
Route ORAL
Labeler Bispit Canada Ltd.
Marketing category UNAPPROVED HOMEOPATHIC
Marketing start 2025-11-03
Substance EPIGALLOCATECHIN GALLATE; PLATYCODON GRANDIFLORUS WHOLE; ASTRAGALUS GUMMIFER ROOT; STYPHNOLOBIUM JAPONICUM FLOWER BUD; FRITILLARIA THUNBERGII WHOLE
Active strength 146; 73; 122; 462; 97 mg/g; mg/g; mg/g; mg/g; mg/g
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 Pulmonary Nodule
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EPIGALLOCATECHIN GALLATE 146 mg/g PLATYCODON GRANDIFLORUS WHOLE 73 mg/g ASTRAGALUS GUMMIFER ROOT 122 mg/g STYPHNOLOBIUM JAPONICUM FLOWER BUD 462 mg/g FRITILLARIA THUNBERGII WHOLE 97 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 5 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 85631-011-01 Pulmonary Nodule 60 in 1 BOTTLE CAPSULE 60 1 85631-011-01 Pulmonary Nodule 1 g in 1 CAPSULE CAPSULE 1 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 85631-011-01 85631001101 60 CAPSULE in 1 BOTTLE (85631-011-01) / 1 g in 1 CAPSULE 60 capsule 2025-11-03 No No Current