FDA.reportPublic FDA data

NDC 0812-0032-35 - NitroMist

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0812-0032
Requested NDC
0812-0032-35
Package NDCs from labels
0812-0032-35
Manufacturer
NovaDel Pharma Inc.
Effective date
2007-03-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
NitroMist - NovaDel Pharma Inc.NovaDel Pharma Inc.2007-03-30HUMAN PRESCRIPTION DRUG LABEL WITH HIGHLIGHTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0812-0032-35NitroMist1 in 1 BOXAEROSOL, SPRAY11
0812-0032-35NitroMist230 in 1 BOTTLEAEROSOL, SPRAY2301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0812-0032NITROMIST (NITROGLYCERIN) AEROSOL, SPRAY FOR TRANSMUCOSAL USE [NOVADEL PHARMA INC.]12 package rows20070517_F9EB07A2-5EBC-40EA-9890-1A0B03E859FF.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NITROGLYCERINACTIVE INGREDIENTG59M7S0WS3NITROMIST (NITROGLYCERIN) AEROSOL, SPRAY FOR TRANSMUCOSAL USE1
nitroglycerinACTIVE MOIETYG59M7S0WS3NITROMIST (NITROGLYCERIN) AEROSOL, SPRAY FOR TRANSMUCOSAL USE1
caprylic/capric diglycerol succinateINACTIVE INGREDIENTNITROMIST (NITROGLYCERIN) AEROSOL, SPRAY FOR TRANSMUCOSAL USE1
L(?)?mentholINACTIVE INGREDIENTNITROMIST (NITROGLYCERIN) AEROSOL, SPRAY FOR TRANSMUCOSAL USE1
n-butaneINACTIVE INGREDIENT6LV4FOR43RNITROMIST (NITROGLYCERIN) AEROSOL, SPRAY FOR TRANSMUCOSAL USE1
peppermint oilINACTIVE INGREDIENTNITROMIST (NITROGLYCERIN) AEROSOL, SPRAY FOR TRANSMUCOSAL USE1

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 ยท 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NITROGLYCERIN LINGUALNITROGLYCERINAllegis Pharmaceuticals, LLCfadd07b7-189b-4678-ad0f-bf1e4d3d13002025-12-17Warnings, Adverse reactionsExact identifier
rxcui: 705129
NITROGLYCERINNITROGLYCERINHF Acquisition Co LLC, DBA HealthFirst422b4713-9531-f1bf-e063-6294a90ada2b2025-10-27Warnings, Adverse reactionsExact identifier
rxcui: 705129
NITROGLYCERIN LINGUALNITROGLYCERIN LINGUALHF Acquisition Co LLC, DBA HealthFirst947e4e68-ef8a-6c63-e053-2a95a90ac1932025-01-08Warnings, Adverse reactionsExact identifier
rxcui: 705129
NITROGLYCERIN LINGUALNITROGLYCERIN LINGUALHF Acquisition Co LLC, DBA HealthFirst9483ea48-0b1e-68c0-e053-2995a90a84d52025-01-08Warnings, Adverse reactionsExact identifier
rxcui: 705129
NITROLINGUALNITROGLYCERININDEPENDENCE PHARMACEUTICALS, LLCd19b5f51-ca85-48d6-9ccd-8ae26249cdc32024-05-13Warnings, Adverse reactionsExact identifier
rxcui: 705129
NITROGLYCERIN LINGUALNITROGLYCERIN LINGUALHF Acquisition Co LLC, DBA HealthFirsta8eb91f6-7f2e-7d57-e053-2995a90a38932024-02-22Warnings, Adverse reactionsExact identifier
rxcui: 705129
NitroglycerinNITROGLYCERINPrasco Laboratoriesf9731c86-34b0-42a2-8b39-eca907e02e742024-01-01Warnings, Adverse reactionsExact identifier
rxcui: 705129
nitroglycerin lingualNITROGLYCERINPadagis Israel Pharmaceuticals Ltde7bbeff1-e4f1-43a6-a1b3-a8c3dcae817d2022-09-01Warnings, Adverse reactionsExact identifier
rxcui: 705129
B7D658B8-0161-20FC-4911-4893205581FBF9EB07A2-5EBC-40EA-9890-1A0B03E859FF2007-03-30Warnings, Adverse reactionsExact identifier
spl id: B7D658B8-0161-20FC-4911-4893205581FB
spl set id: F9EB07A2-5EBC-40EA-9890-1A0B03E859FF

Reported adverse events (FAERS/openFDA)#

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