FDA.reportPublic FDA data

NDC 70518-1364-9 - Ibuprofen

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
70518-1364
Requested NDC
70518-1364-9
Package NDCs from labels
70518-1364-0, 70518-1364-1, 70518-1364-2, 70518-1364-3, 70518-1364-4, 70518-1364-5, 70518-1364-6, 70518-1364-7, 70518-1364-9, 70518-1364-8
Manufacturer
REMEDYREPACK INC.
Effective date
2026-07-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
IBUPROFEN Tablets, USPREMEDYREPACK INC.2026-07-06HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-1364-0Ibuprofen30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3022
70518-1364-1Ibuprofen30 in 1 BLISTER PACKTABLET, FILM COATED3022
70518-1364-2Ibuprofen20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2022
70518-1364-3Ibuprofen45 in 1 BOTTLE, PLASTICTABLET, FILM COATED4522
70518-1364-4Ibuprofen27 in 1 BLISTER PACKTABLET, FILM COATED2722
70518-1364-5Ibuprofen30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3022
70518-1364-6Ibuprofen21 in 1 BOTTLE, PLASTICTABLET, FILM COATED2122
70518-1364-7Ibuprofen30 in 1 BLISTER PACKTABLET, FILM COATED3022
70518-1364-8Ibuprofen100 in 1 BOXTABLET, FILM COATED10022
70518-1364-9Ibuprofen1 in 1 POUCHTABLET, FILM COATED122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1364IBUPROFEN TABLET, FILM COATED [REMEDYREPACK INC.]17Current NDC, Legacy NDC, 10 package rows20250511_b6a6c940-daf6-4e0e-aefb-35cce87a9a55.zip

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 8 of 194 · 3,873 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ibuprofenIBUPROFENSun Pharmaceutical Industries, Inc.9de61620-6750-4fb6-89a4-fe451ab8d99f2026-07-15WarningsExact identifier
unii: WK2XYI10QM
Leg Cramps PMOYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFURHyland's Inc.b0574a7e-88fa-417e-b6d5-60ced59eba472026-07-15WarningsExact identifier
unii: ETJ7Z6XBU4
IbuprofenIBUPROFENStrides Pharma Science Limited38ebacc3-378f-483e-babc-76119677e7df2026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBryant Ranch Prepackf1c88d74-09b0-4b14-baea-106fbbbc54bf2026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA091625
rxcui: 197805
unii: WK2XYI10QM
IbuprofenIBUPROFENCardinal Health 107, LLC0387bfaa-daca-48ec-b718-0216a848c16a2026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197805
unii: WK2XYI10QM
IbuprofenIBUPROFENATLANTIC BIOLOGICALS CORP.3ce7549f-e4db-9f89-e063-6294a90a126d2026-07-10WarningsExact identifier
unii: WK2XYI10QM
Jacksons Cell Salts SILICA 12X 12SILICEAZettl Health Inc.5647dafc-1fff-6a25-e063-6294a90a8b4f2026-07-10Exact identifier
unii: ETJ7Z6XBU4
good sense ibuprofenIBUPROFENBryant Ranch Prepackd6460cc3-c207-44e0-bf78-ad6fef055ed52026-07-09WarningsExact identifier
unii: WK2XYI10QM
Bombee Honey Daily Glow Shield SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEABT ASIA Inc.56112dff-b091-7a56-e063-6294a90a77d32026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DERMIO DERMATOLOGY LLC562f5b0d-6a10-305d-e063-6394a90a59802026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30Suzanne's Skin2soul LLC562fbaa6-f93a-5ec4-e063-6294a90a96342026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Aussie Betta Tallow Sunscreen SPF50 SPF50TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENAUSSIE BETTA HEALTHY CARE PTY LTD56007d82-ff5b-6c26-e063-6294a90a09b62026-07-07WarningsExact identifier
unii: 15FIX9V2JP
IbuprofenIBUPROFENSt. Mary's Medical Park Pharmacy0a98cce4-f5c0-12a8-e063-6294a90a4e7e2026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197807
unii: WK2XYI10QM
EELHOE Body Coverage PerfectorTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.5610c3b7-456b-3bc1-e063-6394a90a3fa82026-07-07WarningsExact identifier
unii: 15FIX9V2JP
IbuprofenIBUPROFENREMEDYREPACK INC.b6a6c940-daf6-4e0e-aefb-35cce87a9a552026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA091625
ndc (package): 70518-1364-4
ndc (package): 70518-1364-6
ndc (package): 70518-1364-2
ndc (package): 70518-1364-3
ndc (package): 70518-1364-5
ndc (package): 70518-1364-1
ndc (package): 70518-1364-7
ndc (package): 70518-1364-8
ndc (package): 70518-1364-9
ndc (package): 70518-1364-0
ndc (product): 70518-1364
ndc11 (package): 70518136409
rxcui: 197806
spl id: 55f1ac9a-98a6-5684-e063-6394a90aa9c1
spl set id: b6a6c940-daf6-4e0e-aefb-35cce87a9a55
unii: WK2XYI10QM
IbuprofenIBUPROFENREMEDYREPACK INC.421156d2-85dc-4680-b2b4-d15b67539e872026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA091625
rxcui: 197807
unii: WK2XYI10QM
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Emerald Aesthetics LLC55f88dd1-346c-22a5-e063-6294a90a711f2026-07-06WarningsExact identifier
unii: 15FIX9V2JP
IbuprofenIBUPROFENBetter Living Brands, LLC45520969-7a2d-4469-ba25-7db160d50ccf2026-07-06WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.c0156053-add5-4bd5-b89f-f90df2e73be42026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197807
rxcui: 197806
unii: WK2XYI10QM
ADVIL DUAL ACTION WITH ACETAMINOPHENIBUPROFEN, ACETAMINOPHENSelect Consumer Group55cd65fc-91bf-4979-e063-6294a90ab9b72026-07-04WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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