FDA.reportPublic FDA data

NDC 31722-339-01 - Naproxen delayed release

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
31722-339
Requested NDC
31722-339-01
Package NDCs from labels
31722-339-01, 31722-339-05, 31722-339-10, 31722-339-50
Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2019-11-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Naproxen Delayed-release Tablets USP, 375 mg and 500 mgPreferred Pharmaceuticals Inc.2019-11-01HUMAN PRESCRIPTION DRUG LABEL
Naproxen Delayed-release Tablets USP, 375 mg and 500 mgBlenheim Pharmacal, Inc.2015-06-05HUMAN PRESCRIPTION DRUG LABEL
Naproxen Delayed Release - Northwind PharmaceuticalsNorthwind Pharmaceuticals2014-06-03HUMAN PRESCRIPTION DRUG LABEL
Naproxen delayed release - Camber Pharmaceuticals | Invagen PharmaceuticalsCamber Pharmaceuticals | Invagen Pharmaceuticals2012-02-01HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
31722-339-052019-11-13C16284748780-197449f38-d247-f6ea-e053-dbdaa90aa703Naproxen Delayed-release Tablets USP, 375 mg and 500 mg
31722-339-502019-11-13C16284748780-197449f38-d247-f6ea-e053-dbdaa90aa703Naproxen Delayed-release Tablets USP, 375 mg and 500 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-339-01Naproxendelayed release100 in 1 BOTTLETABLET1001
31722-339-05Naproxendelayed release24 in 1 CASETABLET241
31722-339-10Naproxendelayed release500 in 1 BOTTLETABLET5001
31722-339-50Naproxendelayed release12 in 1 CASETABLET121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-339NAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [CAMBER PHARMACEUTICALS]1Legacy NDC, 4 package rows20120202_cb3897b7-d4f1-4081-bb3c-e5e270a84930.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-339-01EA - Each31722-33932fab88b-2546-4fb0-affb-67cc227e4c5012012-07-24
31722-339-05EA - Each31722-339f7adaa65-e901-4a7f-8479-75366991f57712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [BLENHEIM PHARMACAL, INC.]2
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [BLENHEIM PHARMACAL, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [BLENHEIM PHARMACAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [BLENHEIM PHARMACAL, INC.]2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JNAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [BLENHEIM PHARMACAL, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [BLENHEIM PHARMACAL, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [BLENHEIM PHARMACAL, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UNAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [BLENHEIM PHARMACAL, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [BLENHEIM PHARMACAL, INC.]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMNAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [BLENHEIM PHARMACAL, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RNAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [BLENHEIM PHARMACAL, INC.]2
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN DELAYED RELEASE TABLET, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS]1
NAPROXENACTIVE INGREDIENT57Y76R9ATQNAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [CAMBER PHARMACEUTICALS]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [CAMBER PHARMACEUTICALS]1
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN DELAYED RELEASE TABLET, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [CAMBER PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [CAMBER PHARMACEUTICALS]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JNAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [CAMBER PHARMACEUTICALS]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [CAMBER PHARMACEUTICALS]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [CAMBER PHARMACEUTICALS]1
TALCINACTIVE INGREDIENT7SEV7J4R1UNAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [CAMBER PHARMACEUTICALS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [CAMBER PHARMACEUTICALS]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMNAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [CAMBER PHARMACEUTICALS]1
WATERINACTIVE INGREDIENT059QF0KO0RNAPROXEN DELAYED RELEASE (NAPROXEN) TABLET [CAMBER PHARMACEUTICALS]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 1 of 150 · 2,984 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
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: FZ989GH94E
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: FZ989GH94E
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Argentum QuartzARGENTUM QUARTZUriel Pharmacy Inc.765c8c8f-0727-45da-a77e-c3907a3d07932026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Endometrium ArgentumENDOMETRIUM ARGENTUMUriel Pharmacy Incd2d1428a-c8b5-9529-e053-2995a90a23432026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
S12 AIRBORNEALFALFA, ALLIUM SATIVUM, ARSENICUM IODATUM, BARLEY, BETULA PUBESCENS, BROWN RICE, CORN GRAIN, EUPHRASIA OFFICINALIS, FEATHER MIX, HAIR MIX, HISTAMINUM, HOUSE DUST MITE, LOLIUM PERENNE, OAT, PERFOLIATE HONEYSUCKLE, PHLEUM PRATENSE, POLLEN MIX, RYE, SABADILLA, SILICEA, SKIN MIX, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TEREBINTHINA, WHEATApex Energetics Inc.bb0036c3-1e4d-5750-e053-2995a90ae8952026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
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
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: FZ989GH94E
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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