FDA.reportPublic FDA data

NDC 59630-300-20 - Nitrolingual

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
59630-300
Requested NDC
59630-300-20
Package NDCs from labels
59630-300-65, 59630-300-20
Manufacturer
FIRST HORIZON PHARMACEUTICAL CORPORATION
Effective date
2006-06-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Nitrolingual - FIRST HORIZON PHARMACEUTICAL CORPORATIONFIRST HORIZON PHARMACEUTICAL CORPORATION2006-06-02HUMAN PRESCRIPTION DRUG LABELING

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59630-300NITROLINGUAL (NITROGLYCERIN) SPRAY [FIRST HORIZON PHARMACEUTICAL CORPORATION]1Unmatched20070323_de06a4da-ea70-441e-bba2-e40eb51a8c3a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59630-300-20GM - Gram59630-300adebc8b2-0e71-4fd5-b2ba-2d26ca9aca2c12016-02-04
59630-300-65GM - Gram59630-3005084d8ba-6562-42d7-be58-d3779ebfc72512016-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
nitroglycerinACTIVE INGREDIENTG59M7S0WS3NITROLINGUAL (NITROGLYCERIN) SPRAY [FIRST HORIZON PHARMACEUTICAL CORPORATION]1
nitroglycerinACTIVE MOIETYG59M7S0WS3NITROLINGUAL (NITROGLYCERIN) SPRAY [FIRST HORIZON PHARMACEUTICAL CORPORATION]1
dehydrated alcoholINACTIVE INGREDIENTNITROLINGUAL (NITROGLYCERIN) SPRAY [FIRST HORIZON PHARMACEUTICAL CORPORATION]1
medium-chain partial glyceridesINACTIVE INGREDIENTNITROLINGUAL (NITROGLYCERIN) SPRAY [FIRST HORIZON PHARMACEUTICAL CORPORATION]1
medium-chain triglyceridesINACTIVE INGREDIENTNITROLINGUAL (NITROGLYCERIN) SPRAY [FIRST HORIZON PHARMACEUTICAL CORPORATION]1
peppermint oilINACTIVE INGREDIENTNITROLINGUAL (NITROGLYCERIN) SPRAY [FIRST HORIZON PHARMACEUTICAL CORPORATION]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 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: 995019
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
1D350400-D80E-24EE-19DA-F13D9EB4ED8Dde06a4da-ea70-441e-bba2-e40eb51a8c3a2006-06-02Warnings, Adverse reactionsExact identifier
spl id: 1D350400-D80E-24EE-19DA-F13D9EB4ED8D
spl set id: de06a4da-ea70-441e-bba2-e40eb51a8c3a

Reported adverse events (FAERS/openFDA)#

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