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 6 of 149 · 2,967 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sun Does Matter Daily Face SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDESundoesmatter Company Inc.553687d8-d4e1-8361-e063-6294a90a24fe2026-06-27WarningsExact identifier
unii: 15FIX9V2JP
NaproxenNAPROXENHAWAII REPACK, INC.888efc91-b4de-4691-b84c-fb871e7a6dfe2026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
NaproxenNAPROXENSt. Mary's Medical Park Pharmacye3a3e5d2-2d1e-74d3-e053-2995a90a82bf2026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 57Y76R9ATQ
Ivory Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f25ba-61d5-6a94-e063-6394a90a46e92026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Simply Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f4799-9122-8db5-e063-6394a90a51322026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Vanilla Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f6d2c-9b8c-aa52-e063-6294a90a787e2026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Coral Isle SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERocky Mountain5515f562-62d9-c6ee-e063-6294a90a9ea62026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Delicate Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551928b4-74bb-3f6c-e063-6294a90a6b832026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Alabaster Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc5519290c-b040-6a37-e063-6394a90a8a1d2026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Soft Bisque Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551ab7d1-dd2f-c6d8-e063-6394a90aff652026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Alabaster Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551b8c21-3afc-c804-e063-6294a90a51562026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Bare Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f20b2-9a2e-70f3-e063-6394a90a93372026-06-25WarningsExact identifier
unii: 15FIX9V2JP
BROAD SPECTRUM SPF 50 UNIVERSAL TINTED SUNSCREENTITANIUM DIOXIDEShantou Woodsleep Biotechnology Co., Ltd.54fc80b7-8f6c-e2be-e063-6394a90a4b592026-06-24WarningsExact identifier
unii: 15FIX9V2JP
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
Cerave Developed with Dermatologists Hydrating Sunscreen SPF 30 Body Lightweight, non-greasy feel 3 essential ceramides Mineral SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc54ecaea7-dafe-9694-e063-6394a90ae3b52026-06-23WarningsExact identifier
unii: 15FIX9V2JP
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
RYDEEN UV CLEARSUNSCREENGuangzhou Oupeng Cosmetics Co., Ltd.548000cd-1655-aeb3-e063-6294a90ad0042026-06-22WarningsExact identifier
unii: 15FIX9V2JP
Good Instincts Proper Sunscreen SPF 50ZINC OXIDE, TITANIUM DIOXIDEInhabit Brands, Inc82d2af99-7c42-4ce5-94e0-b2ac60b8db1b2026-06-22WarningsExact identifier
unii: 15FIX9V2JP
ESPOIR BE VELVET COVER CUSHIONHOMOSALATE, TITANIUM DIOXIDEESPOIR Corporation54ce2420-4ac0-eb51-e063-6294a90a2de92026-06-21WarningsExact identifier
unii: 15FIX9V2JP
BABIES KIDSSUN PROTECTIONMINERAL SUNSCREENPANERGYTEK USA INC3a554118-b71d-a844-e063-6294a90a699f2026-06-20WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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