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 1 of 231 · 4,613 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COLTALIN-DMACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEFORTUNE PHARMACAL COMPANY LIMITED33e1bec0-323b-40b7-809a-cb65a71ad0ce2026-09-17WarningsExact identifier
unii: 04JA59TNSJ
unii: V1Q0O9OJ9Z
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRGeiss, Destin & Dunn Inc.1ea07a01-8779-48c2-a287-b7be866cce7b2026-09-10WarningsExact identifier
unii: V1Q0O9OJ9Z
Childrens Cold and Allergy ReliefBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLStrategic Sourcing Services LLCd64fe757-9948-4727-b5dd-1f8e4e4763e22026-09-10WarningsExact identifier
unii: 04JA59TNSJ
Cold and Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATEKroger Companyfd41e4a4-330f-4409-8ba3-0b3bb6f45bca2026-09-10WarningsExact identifier
unii: V1Q0O9OJ9Z
Mucus Relief Cold Flu and Sore Throat Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRaritan Pharmaceuticals Inc2cb3e17f-3858-4773-a53f-0860ae6ff1b92026-09-09WarningsExact identifier
unii: 04JA59TNSJ
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: 532B59J990
unii: FZ989GH94E
severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDERite Aid Corporation4b8ae971-ab57-4937-a878-72d905d7b8492026-09-09WarningsExact identifier
unii: 04JA59TNSJ
Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCARDINAL HEALTH 110, LLC. DBA LEADER 7000082ba9a73-60ef-49fd-960f-5ca2bb79555e2026-09-09WarningsExact identifier
unii: 04JA59TNSJ
DRx Choice Childrens Stuffy Nose and Chest CongestionGUAIFENESIN AND PHENYLEPHRINE HCLRARITAN PHARMACEUTICALS7a3bb739-ff50-4d29-b270-d6b0849064932026-09-09WarningsExact identifier
unii: 04JA59TNSJ
Mucus Relief Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRaritan Pharmaceuticals Inc8a166067-b492-4742-b74c-28fac87c8d702026-09-09WarningsExact identifier
unii: 04JA59TNSJ
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
unii: 04JA59TNSJ
Vicks DayQuil VapoCOOL SEVERE COLD and FLU plus CONGESTIONACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Companyefb69cc1-a745-6efc-e053-2a95a90abdc92026-09-08WarningsExact identifier
unii: 04JA59TNSJ
Vicks NyQuil VapoCOOL Severe COLD and FLU plus CONGESTIONACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDEThe Procter & Gamble Manufacturing Companyefb5f0b9-9825-ab23-e053-2995a90a26ab2026-09-08WarningsExact identifier
unii: 04JA59TNSJ
Vicks childrens Cough CongestionPHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, GUAIFENESINThe Procter & Gamble Manufacturing Companye2356457-9791-3710-e053-2995a90ad1402026-09-08WarningsExact identifier
unii: 04JA59TNSJ
Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINERARITAN PHARMACEUTICALS INC9819155b-2713-42be-867e-16605e7643d02026-09-08WarningsExact identifier
unii: 04JA59TNSJ
Cold and Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATEWALMART INC.f9d1dfd1-527f-491d-9188-14886ac70ced2026-09-08WarningsExact identifier
unii: V1Q0O9OJ9Z
severe cold and cough daytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDERARITAN PHARMACEUTICALS INC3ce8508e-7d9d-4413-858a-8f952e760c012026-09-08WarningsExact identifier
unii: 04JA59TNSJ
Multi Symptom Severe ColdACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLRARITAN PHARMACEUTICALS INCd9606c9a-31b1-4121-9870-809a05f5b68a2026-09-08WarningsExact identifier
unii: 04JA59TNSJ

Reported adverse events (FAERS/openFDA)#

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