FDA.reportPublic FDA data

NDC 0113-4368-00 - Good Sense Naproxen Sodium

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
0113-4368
Requested NDC
0113-4368-00
Package NDCs from labels
0113-4368-62, 0113-4368-71, 0113-4368-78, 0113-4368-76, 0113-4368-79, 0113-4368-75, 0113-4368-00, 0113-4368-82
Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2026-07-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Perrigo Naproxen Sodium Tablets, 220 mg Drug FactsPreferred Pharmaceuticals Inc.2026-07-28HUMAN OTC DRUG LABEL
Good Sense Naproxen Sodium - L. Perrigo CompanyL. Perrigo Company2026-05-11HUMAN OTC DRUG LABEL
Good Sense Naproxen Sodium - Bryant Ranch PrepackBryant Ranch Prepack2025-08-26HUMAN OTC DRUG LABEL
Cold FAid - Cold FAid | The Arc of MonroeCold FAid | The Arc of Monroe2021-07-21HUMAN OTC DRUG LABEL
Naproxen Sodium - Direct_RxDirect_Rx2021-06-09HUMAN PRESCRIPTION DRUG LABEL
Naproxen Sodium - Denton Pharma, Inc. DBA Northwind PharmaceuticalsDenton Pharma, Inc. DBA Northwind Pharmaceuticals2021-01-21HUMAN OTC DRUG LABEL
Good Sense Naproxen Sodium - Quality Care Products, LLCQuality Care Products, LLC2020-11-03HUMAN OTC DRUG LABEL
Good Sense Naproxen Sodium - Proficient Rx LPProficient Rx LP2019-11-01HUMAN OTC DRUG LABEL
Good Sense Naproxen Sodium - A-S Medication SolutionsA-S Medication Solutions2018-09-26HUMAN OTC DRUG LABEL
Perrigo Naproxen Sodium Tablets, 220 mg Drug FactsNuCare Pharmaceuticals,Inc.2018-02-08HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0113-4368-00Good Sense Naproxen Sodium200 in 1 BOTTLETABLET, FILM COATED20010
0113-4368-62Good Sense Naproxen Sodium24 in 1 BOTTLETABLET, FILM COATED2410
0113-4368-62Good Sense Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED110
0113-4368-71Good Sense Naproxen Sodium50 in 1 BOTTLETABLET, FILM COATED5010
0113-4368-71Good Sense Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED110
0113-4368-75Good Sense Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED110
0113-4368-75Good Sense Naproxen Sodium90 in 1 BOTTLETABLET, FILM COATED9010
0113-4368-76Good Sense Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED110
0113-4368-76Good Sense Naproxen Sodium120 in 1 BOTTLETABLET, FILM COATED12010
0113-4368-78Good Sense Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED110
0113-4368-78Good Sense Naproxen Sodium100 in 1 BOTTLETABLET, FILM COATED10010
0113-4368-79Good Sense Naproxen Sodium400 in 1 BOTTLETABLET, FILM COATED40010
0113-4368-82Good Sense Naproxen Sodium1 in 1 CARTONTABLET, FILM COATED110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-4368GOOD SENSE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [L. PERRIGO COMPANY]8Current NDC, Legacy NDC, 13 package rows20240328_8e150c00-8e5b-40b4-a964-cb70442c2752.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-4368-62EA - Each0113-4368bc67d066-2a1e-4806-a7c1-e232b732e93b12018-02-20
0113-4368-71EA - Each0113-4368993338e5-109e-4ef6-9be0-b5f443412b5712018-02-20
0113-4368-76EA - Each0113-436844440010-53b4-4de7-9f66-fda678f65a3512024-02-14
0113-4368-78EA - Each0113-4368e8dafb0f-462d-4fc5-bfb9-c6567df41bbd12017-03-06
0113-4368-79EA - Each0113-43684abd9a15-8206-4d60-bf29-504433dc3b2912023-03-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CGOOD SENSE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [L. PERRIGO COMPANY]3
NAPROXENACTIVE MOIETY57Y76R9ATQGOOD SENSE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [L. PERRIGO COMPANY]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGOOD SENSE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [L. PERRIGO COMPANY]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGOOD SENSE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [L. PERRIGO COMPANY]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GOOD SENSE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [L. PERRIGO COMPANY]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGOOD SENSE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [L. PERRIGO COMPANY]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EGOOD SENSE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [L. PERRIGO COMPANY]3
TALCINACTIVE INGREDIENT7SEV7J4R1UGOOD SENSE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [L. PERRIGO COMPANY]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGOOD SENSE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [L. PERRIGO COMPANY]3

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 4 of 226 · 4,516 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aging Eye FormulaCINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUMNutritional Specialties, Inc.d5b44f79-5299-4b31-ba45-0e511cdbe17c2026-08-24WarningsExact identifier
unii: ETJ7Z6XBU4
Cold, Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.9be8437c-6053-4ed4-bdd2-97f556b5289e2026-08-24WarningsExact identifier
unii: 04JA59TNSJ
DG HEALTH MULTI SYMPTOM SEVERE COLDACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLDolgencorp, LLC47ddbb0d-0823-4817-9c56-e7fff77d601c2026-08-21WarningsExact identifier
unii: 04JA59TNSJ
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: FZ989GH94E
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Numb520SprayLIDOCAINE, PHENYLEPHRINE HCLEbanel Laboratories, Inc.350f0e25-fbdc-c0c0-e063-6294a90a50a02026-08-20WarningsExact identifier
unii: 04JA59TNSJ
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
Psorinum ComplexPHOSPHORUS, SILICEA, SULPHUR, ALOEBioActive Nutritional, Inc.d4746927-e6d4-463d-a084-56ffc48d1e672026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Boneforce HPCALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, RHUS TOX, SILICEA, SYMPHYTUM OFFICINALEBioActive Nutritional, Inc.d96ca52b-781d-431c-ad2a-a54fd57eb1062026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Naproxen SodiumNAPROXEN SODIUMBryant Ranch Prepack2794b60d-d09b-4115-9ff2-07ff15524e782026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9TN87S3A3C
Naproxen SodiumNAPROXEN SODIUMTARGET Corporation36ce5cd9-8c61-4ed9-b840-c29ad98bdfc52026-08-20WarningsExact identifier
unii: 9TN87S3A3C
HyVee Nighttime Severe Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEHyVee Inc49818610-bf4a-fb86-e063-6294a90ae5982026-08-20WarningsExact identifier
unii: 04JA59TNSJ
HyVee Daytime Severe Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEHyVee Inc496ec389-1aea-f202-e063-6394a90ae51c2026-08-20WarningsExact identifier
unii: 04JA59TNSJ
CVS Maximum Strength Severe Congestion and CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECVS PHARMACY, INCbfb3d021-f65f-499c-bbb1-c1aceb7a7bf92026-08-19WarningsExact identifier
unii: 04JA59TNSJ
CVS Childrens Cold plus Cough plus Runny NoseACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDECVS7dc30e46-e289-40fc-b217-b123fee5daee2026-08-19WarningsExact identifier
unii: V1Q0O9OJ9Z
nighttime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLAmazon.com Services LLC2517b241-c433-440f-999d-5a32d5bbaa262026-08-19WarningsExact identifier
unii: 04JA59TNSJ
Phenylephrine HydrochloridePHENYLEPHRINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.e1a7ab4b-0afe-4463-a039-5be0323cf2f72026-08-19Warnings, Adverse reactionsExact identifier
unii: 04JA59TNSJ
CVS Maximum Strength Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN ,PHENYLEPHRINE HCLCVS PHARMACYe1c246a4-7a8c-4761-ab26-13b5165029cc2026-08-19WarningsExact identifier
unii: 04JA59TNSJ
CVS childrens Cough and ColdCHLORPHENIRAMINE MALEATE, DEXTROMETRORPHAN HBRCVS PHARMACY035c5e2a-04e3-490b-8f1a-233a5cb6eadb2026-08-19WarningsExact identifier
unii: V1Q0O9OJ9Z

Reported adverse events (FAERS/openFDA)#

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