FDA.reportPublic FDA data

NDC 49035-368-98 - equate 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
49035-368
Requested NDC
49035-368-98
Package NDCs from labels
49035-368-62, 49035-368-78, 49035-368-87, 49035-368-98, 49035-368-47
Manufacturer
Wal-Mart Stores Inc
Effective date
2019-11-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
equate naproxen sodium - Wal-Mart Stores IncWal-Mart Stores Inc2019-11-22HUMAN OTC DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-368-62EA - Each49035-3688dca6cc1-616f-4a6f-b4a6-8bcd6ef0da1212016-06-14
49035-368-78EA - Each49035-368d5bb4e6f-97c9-4971-8af5-cbcae13c85a312013-12-02
49035-368-87EA - Each49035-3684ee64d5b-ce0b-4b08-bdb7-93ceab852c7b12019-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CEQUATE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [WAL-MART STORES INC]3
NAPROXENACTIVE MOIETY57Y76R9ATQEQUATE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [WAL-MART STORES INC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UEQUATE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [WAL-MART STORES INC]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOEQUATE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [WAL-MART STORES INC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30EQUATE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [WAL-MART STORES INC]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AEQUATE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [WAL-MART STORES INC]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EEQUATE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [WAL-MART STORES INC]3
TALCINACTIVE INGREDIENT7SEV7J4R1UEQUATE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [WAL-MART STORES INC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEQUATE NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [WAL-MART STORES INC]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 120 · 2,392 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: 3NXW29V3WO
NaproxenNAPROXEN SODIUML.N.K. International, Inc.82412133-c11a-4905-a119-965f44de10b72026-08-17WarningsExact identifier
unii: 9TN87S3A3C
Naproxen SodiumNAPROXEN SODIUMHarris Teeter27938b08-ff37-4587-aa81-5ec3ef21a28a2026-08-12WarningsExact identifier
unii: 9TN87S3A3C
Naproxen SodiumNAPROXEN SODIUMHarris Teeter38543976-ccbe-4af9-b01d-ae102452d4182026-08-12WarningsExact identifier
unii: 9TN87S3A3C
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DR. SAMRAO'S OFFICE58b2ca35-11ed-d848-e063-6294a90a5b372026-08-11WarningsExact identifier
unii: 15FIX9V2JP
Dr. Shitong Photon Energy Eye Care LiquidTETRAHYDROZOLINE HCL 0.05% HYPROMELLOSE 0.3% DR. SHITONG PHOTON ENERGY EYE CARE LIQUIDWenzhou Yuyuan Pharmaceutical Co., Ltd.58ace434-55ef-17ef-e063-6294a90aa8782026-08-10WarningsExact identifier
unii: 3NXW29V3WO
Journee Firm Riche Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE AND ZINC OXIDEMerz North America, Inc.d4d4bfcf-3674-4847-8ad8-1716a8e821ae2026-08-10WarningsExact identifier
unii: 15FIX9V2JP
VEIRFOO Brightening Hydrating Antiwrinkle SunscreenTITANIUM DIOXIDE, OCTINOXATELCM TECHNOLOGY Co., Ltd4cbbf8aa-8910-b7e7-e063-6294a90a4f072026-08-07WarningsExact identifier
unii: 15FIX9V2JP
Naproxen SodiumNAPROXEN SODIUMBryant Ranch Prepackbee7b482-8ba5-411d-90ee-de00df50d2b72026-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9TN87S3A3C
Naproxen SodiumNAPROXEN SODIUMBryant Ranch Prepacke9eb8c40-85d9-4c8e-9523-a21d3591260f2026-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9TN87S3A3C
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
unii: 15FIX9V2JP
ArtridolNAPROXEN SODIUMZapotol Products Corpc422d300-3f4e-4121-8eaf-56683911b8842026-08-05WarningsExact identifier
unii: 9TN87S3A3C
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEYOCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%Lale Cosmetics LLC581fb0cd-c55d-d562-e063-6394a90a7f112026-08-03WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV ActiveZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc39d16479-d491-4c19-aa11-674461687c7b2026-08-03WarningsExact identifier
unii: 15FIX9V2JP
Continuous Correction CreamTITANIUM DIOXIDEBaxter of California, LLC1cbcc648-f2e1-af60-e063-6294a90ad4bb2026-07-31WarningsExact identifier
unii: 15FIX9V2JP
Cover CremeTITANIUM DIOXIDEBaxter of California31f5e8c4-523f-4596-e063-6294a90a6a122026-07-31WarningsExact identifier
unii: 15FIX9V2JP
Good Sense Naproxen SodiumNAPROXEN SODIUMPreferred Pharmaceuticals Inc.2183df53-ac90-4d43-8a5d-8421036bc4cb2026-07-28WarningsExact identifier
application number: ANDA074661
unii: 9TN87S3A3C
NaproxenNAPROXEN SODIUMPreferred Pharmaceuticals, Inc.20eb9d9f-11df-464f-a1b0-949f8fda40422026-07-28WarningsExact identifier
unii: 9TN87S3A3C
Naproxen SodiumNAPROXEN SODIUMPD-Rx Pharmaceuticals, Inc.d2b1eedb-2be0-42af-ba0b-9da98560c91e2026-07-24WarningsExact identifier
application number: ANDA074661
unii: 9TN87S3A3C

Reported adverse events (FAERS/openFDA)#

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