FDA.reportPublic FDA data

NDC 80425-0475-01 - Sumatriptan

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
80425-0475
Requested NDC
80425-0475-01
Package NDCs from labels
80425-0475-1, 80425-0475-01
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2024-12-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sumatriptan - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2024-12-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0475-1Sumatriptan9 in 1 BLISTER PACKTABLET, FILM COATED91
80425-0475-1Sumatriptan1 in 1 CARTONTABLET, FILM COATED11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0475SUMATRIPTAN TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 2 package rows20250103_2aab8786-b225-833a-e063-6394a90ac7ae.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0475-1EA - Each80425-0475fc6dda65-8bf6-41f1-a0e3-e4499582e1b512025-02-10

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 73 of 123 · 2,456 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral Tinted SPF 30 Mineral Tinted SPF 30 Broad Spectrum Sunscreen Water Resistant (80 min)TITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciencesadcd6881-fa25-4312-95e5-5b47102aa6b92025-06-05WarningsExact identifier
unii: 15FIX9V2JP
Mineral Moisture Defense SPF 50TITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciences05ad73f3-a4e8-4f78-8212-3e8e3bda988c2025-06-05WarningsExact identifier
unii: 15FIX9V2JP
Solar SPF 40 Broad Spectrum SPF 40 Water Resistant (80 min) Mineral SuncreenTITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciences6ce602bb-c1f4-43c1-ae61-0f05d7952db32025-06-05WarningsExact identifier
unii: 15FIX9V2JP
Solar stick Tinted SPF 40 Tinted Broad Spectrum SPF 40 Water Resistant (80 min) Mineral SuncreenTITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciencesb8f08778-7e5e-4341-9a24-1ce57c6525c72025-06-05WarningsExact identifier
unii: 15FIX9V2JP
Nemah SPF 30 Mineral C/S Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDENemah, Inc.36da2d94-fa90-b145-e063-6394a90a58542025-06-05WarningsExact identifier
unii: 15FIX9V2JP
Mineral KidStick SPF 40 Mineral Broad Spectrum SPF 40 Sunscreen UVA-UVB SuncreenTITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciences4c7f0257-fa12-40d6-9516-824b0e3a182c2025-06-05WarningsExact identifier
unii: 15FIX9V2JP
Mineral KidCreme SPF 50TITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciences9ec56c68-6fea-444b-aeed-0b5d60c42e752025-06-05WarningsExact identifier
unii: 15FIX9V2JP
Aveeno Calm Plus Restore Daily Moisturizer Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLCfbf8be03-93e2-4d7e-e053-6294a90a4fd52025-06-04WarningsExact identifier
unii: 15FIX9V2JP
Age Defense for Eyes 5 in 1ZINC OXIDE AND TITANIUM DIOXIDETopiderm, Inc.48d5343a-1068-4c64-a275-c180026d69472025-06-03WarningsExact identifier
unii: 15FIX9V2JP
Bluevado SunfixZINC OXIDE, TITANIUM DIOXIDEMagic Blue, LLC31f1e961-3719-f70a-e063-6394a90a481e2025-05-31WarningsExact identifier
unii: 15FIX9V2JP
PRISMASOL BGK2/0MAGNESIUM CHLORIDE, DEXTROSE ANHYDROUS, LACTIC ACID, SODIUM CHLORIDE, SODIUM BICARBONATE, AND POTASSIUM CHLORIDEVantive US Healthcare LLC7f675fee-8940-4ece-bb0c-75ac79d8708c2025-05-31Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
SumatriptanSUMATRIPTANEugia US LLC9b1bb8c9-be3a-47c3-b3bc-9c983cde7d232025-05-29Warnings, Adverse reactionsExact identifier
unii: J8BDZ68989
Dr. Mercola Broad SpectrumTITANIUM DIOXIDE, ZINC OXIDENatural Health Partners, LLC47f6ab9e-fa73-496a-e054-00144ff8d46c2025-05-28WarningsExact identifier
unii: 15FIX9V2JP
AHHH Bite ReliefSODIUM BICARBONATE7827125a1e070-9228-4ec9-e063-6294a90ad78d2025-05-27WarningsExact identifier
unii: 8MDF5V39QO
Protect Daily Ritual Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.35ce8307-387b-2b40-e063-6294a90a28bc2025-05-23Exact identifier
unii: 15FIX9V2JP
Insecticides/Pest/Food Additives DetoxBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDr. Donna Restivo DCb5778211-0e3e-44ef-bd65-a76a68cf15042025-05-23WarningsExact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.35bea4f3-c19e-3e2e-e063-6394a90aeb692025-05-22Exact identifier
unii: 15FIX9V2JP
sumatriptanSUMATRIPTANRising Pharma Holdings, Inc.352d2ab3-d2c7-48c8-bcd4-d46ed9bdfa852025-05-21Warnings, Adverse reactionsExact identifier
rxcui: 315223
rxcui: 313160
rxcui: 313161
unii: J8BDZ68989
Mineral Stick Non-TintedTITANIUM DIOXIDE, ZINC OXIDEIT INTELLIGENT TREATMENT LLC3595149d-0735-6bea-e063-6394a90a618a2025-05-20Exact identifier
unii: 15FIX9V2JP
Mineral Stick TintedTITANIUM DIOXIDE, ZINC OXIDEIT INTELLIGENT TREATMENT LLC3595735e-c25f-eb48-e063-6294a90aac0f2025-05-20Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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