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 2 of 226 · 4,516 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Multi Symptom Severe ColdACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLRARITAN PHARMACEUTICALS INCd9606c9a-31b1-4121-9870-809a05f5b68a2026-09-08WarningsExact identifier
unii: 04JA59TNSJ
Mucus Relief Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLChain Drug Marketing Association, Inc.2a7afe03-3c34-4e30-827e-b3bb2568cb972026-09-08WarningsExact identifier
unii: 04JA59TNSJ
Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLMeijer Distribution, Inc.49235f4f-e661-4a83-88ef-b9a9568487772026-09-04WarningsExact identifier
unii: 04JA59TNSJ
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: 532B59J990
unii: FZ989GH94E
Cough and Cold HBPCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRTopco Associates, LLCed576bf1-3949-423e-af2e-e4b1a3839b212026-09-04WarningsExact identifier
unii: V1Q0O9OJ9Z
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMCVS Pharmacy3167c918-a7d3-46a1-a85b-64f9c22916f22026-09-04WarningsExact identifier
unii: 04JA59TNSJ
Dollar GeneralNASAL PHENYLEPHRINE HYDROCHLORIDEDOLGENCORP, INC. (DOLLAR GENERAL & REXALL)e8fd3f0e-a023-4423-8906-17ae02bc083b2026-09-03WarningsExact identifier
unii: 04JA59TNSJ
Mucus Relief Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCITARGET Corporation1bf9a59e-cc37-4780-ba75-7138c546eb192026-09-02WarningsExact identifier
unii: 04JA59TNSJ
Childrens Multi Symptom Fever and ColdACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLTHE KROGER CO.3daf7620-eb57-43d5-ba88-938b7221e3462026-09-02WarningsExact identifier
unii: 04JA59TNSJ
unii: V1Q0O9OJ9Z
PHENAGILPHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATEGil Pharmaceutical Corp69fd13a1-2b76-8574-e053-2a91aa0a27e72026-09-02WarningsExact identifier
unii: 04JA59TNSJ
unii: V1Q0O9OJ9Z
PHENAGILCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCLGil Pharmaceutical Corp.a6880389-0dc1-43a7-a73b-77f77bafe51e2026-09-02WarningsExact identifier
unii: 04JA59TNSJ
unii: V1Q0O9OJ9Z
PHENAGILPHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATEGil Pharmaceutical Corpfa8510d8-d50a-4743-ba87-a12e9ab431252026-09-02WarningsExact identifier
unii: 04JA59TNSJ
unii: V1Q0O9OJ9Z
PHENAGILCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCLGil Pharmaceutical Corpdfcf1231-8271-458d-b375-e328d6fd4e9b2026-09-02WarningsExact identifier
unii: 04JA59TNSJ
unii: V1Q0O9OJ9Z
Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINEKROGER COMPANY7def6781-0881-46bf-ad7a-7a3f23a8d9f72026-09-02WarningsExact identifier
unii: 04JA59TNSJ
Kroger Maximum Strength Severe Congestion and CoughDEXTROMETHORPHAN HBR, GUAIFENESIN, AND PHENYLEPHRINE HCLKROGER COMPANY1ff037ea-1a3b-430a-be31-2e240cc3b6f32026-09-02WarningsExact identifier
unii: 04JA59TNSJ
Maximum Strength Cold Flu and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLKROGER COMPANYe1d27123-358f-4b0c-8e3b-33474750a0e62026-09-02WarningsExact identifier
unii: 04JA59TNSJ
Maximum Strength Nighttime Cold and FluACETAMINOPHEN , DIPHENHYDRAMINE HCL,PHENYLEPHRINE HCLTHE KROGER CO058b2021-8a61-40b0-8a2e-a784d2b847fb2026-09-02WarningsExact identifier
unii: 04JA59TNSJ
Daytime Cold and Flu ReliefACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCLThe Kroger Co.494e69ef-dc9f-4e14-b856-5eaf0f541a032026-09-02WarningsExact identifier
unii: 04JA59TNSJ
Lidocaine PhenylephrineLIDOCAINE PHENYLEPHRINEYYBA CORP5a72a190-2129-411e-e063-6394a90a08c22026-09-01WarningsExact identifier
unii: 04JA59TNSJ

Reported adverse events (FAERS/openFDA)#

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