Pulmonary Nodule

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Pulmonary Nodule
Generic name: PULMONARY NODULE
Manufacturer: Bispit Canada Ltd.
Product type: HUMAN OTC DRUG
SPL set ID: 42af8bf8-80b4-e1a1-e063-6394a90a306c
SPL ID: 42af8bf8-80b5-e1a1-e063-6394a90a306c
Version: 1
Effective date: 2025-11-03
Source export date: 2026-09-28
Source partition: 10
Source file: https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:07:15

Harmonized routes table
Harmonized routes
ORAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 13 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		Pulmonary Nodule	openfda.brand_name
generic name		PULMONARY NODULE	openfda.generic_name
manufacturer name		Bispit Canada Ltd.	openfda.manufacturer_name
ndc	package	85631-011-01	openfda.package_ndc
ndc	product	85631-011	openfda.product_ndc
ndc11	package	85631001101	derived:openfda.package_ndc
spl id		42af8bf8-80b5-e1a1-e063-6394a90a306c	id
spl set id		42af8bf8-80b4-e1a1-e063-6394a90a306c	set_id
unii		BQM438CTEL	openfda.unii
unii		10T15Y9F0M	openfda.unii
unii		8V19OM31TK	openfda.unii
unii		WC73QE9274	openfda.unii
unii		DES4RX1Z3E	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

This product is not a substitute formedication.For severe lung diseases such aslung cancer, pulmonary fibrosis, and severepneumonia, please follow your doctor'sadvice:Not recommended for pregnant women,breastfeeding women, infants, and children;Not recommended for those allergic to theproduct's ingredients;

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.