FDA.reportPublic FDA data

NDC 0498-7501-01 - Cedaprin

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
0498-7501
Requested NDC
0498-7501-01
Package NDCs from labels
0498-7501-01, 0498-7501-10, 0498-7501-25, 0498-7501-50
Manufacturer
Honeywell Safety Products USA, Inc
Effective date
2024-01-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Cedaprin - Honeywell Safety Products USA, IncHoneywell Safety Products USA, Inc2024-01-19HUMAN OTC DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMCEDAPRIN (IBUPROFEN) TABLET [NORTH SAFETY PRODUCTS LLC ]1
IBUPROFENACTIVE MOIETYWK2XYI10QMCEDAPRIN (IBUPROFEN) TABLET [NORTH SAFETY PRODUCTS LLC ]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZCEDAPRIN (IBUPROFEN) TABLET [NORTH SAFETY PRODUCTS LLC ]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCEDAPRIN (IBUPROFEN) TABLET [NORTH SAFETY PRODUCTS LLC ]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CEDAPRIN (IBUPROFEN) TABLET [NORTH SAFETY PRODUCTS LLC ]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCEDAPRIN (IBUPROFEN) TABLET [NORTH SAFETY PRODUCTS LLC ]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCEDAPRIN (IBUPROFEN) TABLET [NORTH SAFETY PRODUCTS LLC ]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACEDAPRIN (IBUPROFEN) TABLET [NORTH SAFETY PRODUCTS LLC ]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CEDAPRIN (IBUPROFEN) TABLET [NORTH SAFETY PRODUCTS LLC ]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CEDAPRIN (IBUPROFEN) TABLET [NORTH SAFETY PRODUCTS LLC ]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DCEDAPRIN (IBUPROFEN) TABLET [NORTH SAFETY PRODUCTS LLC ]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IECEDAPRIN (IBUPROFEN) TABLET [NORTH SAFETY PRODUCTS LLC ]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ACEDAPRIN (IBUPROFEN) TABLET [NORTH SAFETY PRODUCTS LLC ]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CEDAPRIN (IBUPROFEN) TABLET [NORTH SAFETY PRODUCTS LLC ]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCEDAPRIN (IBUPROFEN) TABLET [NORTH SAFETY PRODUCTS LLC ]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 32 of 189 · 3,777 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ibuprofenIBUPROFENHyVee Incc20a9bc5-e481-4fb2-ad10-d01e83e43ca02026-02-21WarningsExact identifier
unii: WK2XYI10QM
Allergy Maximum StrengthURTICA DIOICA, ALTHAEA OFFICINALIS ROOT, INULA HELENIUM ROOT, ANGELICA ARCHANGELICA ROOT, PINE NEEDLE OIL (PINUS SYLVESTRIS), SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature122ca23e-43f1-4e5c-afc2-1418b17176792026-02-20WarningsExact identifier
unii: ETJ7Z6XBU4
Perfect Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESKIN PERFECT MEDICAL4b47e7cb-17d6-6a7c-e063-6294a90abbea2026-02-20WarningsExact identifier
unii: 15FIX9V2JP
IbuprofenIBUPROFENAphena Pharma Solutions - Tennessee, LLC4522b794-5c93-44cd-e063-6394a90ab39a2026-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
CalamineFERRIC OXIDE REDPerrigo Direct, Inc256bd1d4-fd50-408f-9aee-84f218bb49712026-02-19Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineCALAMINE, PRAMOXIND HCLPerrigo Direct, Inc54a20ec9-ab86-4410-af94-e04393e9d4b32026-02-19Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineCALAMINE, PRAMOXINE HCLMeijer, Inc.6b369ef2-fd54-4931-a9eb-0fb42834c2ef2026-02-19Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
IbuprofenIBUPROFENNuCare Pharmaceuticals, Inc.4b34b58b-2cf7-9aa8-e063-6294a90a06582026-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Allay Skin Solutions Protect Nourish Mineral Sunscreen SPF 42TITANIUM DIOXIDE, ZINC OXIDEALLAY SKIN SOLUTIONS LLC425bf1d7-f2cf-4237-9047-dd53054acd1c2026-02-18WarningsExact identifier
unii: 15FIX9V2JP
CalamineFERRIC OXIDE REDTarget Corporationd4ee05c8-ae62-45df-8783-1ed57fa030ec2026-02-18Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Hermes Plein Air-Baume de Teint Perfecteur Naturel-Enhancing Complexion Balm 85 TAMARINTITANIUM DIOXIDES.A. COMPTOIR NOUVEAU DE LA PARFUMERIEdacff3dc-49d7-6416-e053-2a95a90a85c62026-02-18WarningsExact identifier
unii: 15FIX9V2JP
Mitochondria ProARALIA QUINQUEFOLIA, ARNICA MONTANA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, ASCORBICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, CALCAREA CARBONICA, CITRICUM ACIDUM, CUPRUM METALLICUM, CYSTEINUM, FERRUM METALLICUM, IODIUM, LEVOTHYROXINUM, MAGNESIUM GLUCONICUM DIHYDRICUM, MALICUM ACIDUM, MANGANUM ACETICUM, NADIDUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, SELENIUM METALLICUM, SULPHUR, THIAMINUM HYDROCHLORICUM, UBIDECARENONUM, ZINCUM METALLICUM,Energique, Inc.2f365207-b730-428d-9465-8853e86e79ff2026-02-18WarningsExact identifier
unii: ETJ7Z6XBU4
BIO COM 25 ACIDITYNAT PHOS, NAT SULPH, SILICEABM Private Limited3b3c3455-b321-071d-e063-6394a90a01602026-02-17WarningsExact identifier
unii: ETJ7Z6XBU4
CVS IbuprofenIBUPROFENCVS Pharmacy3d71e29f-0648-7377-e063-6294a90a8a292026-02-17WarningsExact identifier
application number: ANDA079129
unii: WK2XYI10QM
IbuprofenIBUPROFENA-S Medication Solutions0170876a-d8cd-4a2d-8397-db2acdf72ffb2026-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
CINAAMBROSIA, CINA, CUCURBITA CIT, CUCURBITA PEP, INDIGO, SANTONINE, SILICEABM PRIVATE LIMITED3b3c0874-90b5-deda-e063-6394a90a78022026-02-15WarningsExact identifier
unii: ETJ7Z6XBU4
Acne/Pimple ControlCALENDULA OFFICINALIS FLOWERING TOP AND SILICON DIOXIDEForces of Naturee871e46e-463e-49ec-a2af-5aa98548ee122026-02-13WarningsExact identifier
unii: ETJ7Z6XBU4
CalamineFERRIC OXIDE REDTopco Associates LLC2b32e720-ac71-4d60-bc06-e28a00f8a4502026-02-13Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineCALAMINE, PRAMOXINE HCLTopco Associates LLC15d1ae3f-509c-4e6b-8f0c-cf92656803582026-02-13Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Ibuprofen ChildrensIBUPROFENMajor Pharmaceuticals9d56e64d-7860-4fd1-88d2-c537e50079d82026-02-13WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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