FDA.reportPublic FDA data

NDC 50580-110-03 - Motrin IB

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
50580-110
Requested NDC
50580-110-03
Package NDCs from labels
50580-110-01, 50580-110-02, 50580-110-07, 50580-110-09, 50580-110-10, 50580-110-19, 50580-110-38, 50580-110-51, 50580-110-52, 50580-110-60, 50580-110-62, 50580-110-75, 50580-110-76, 50580-110-95, 50580-110-03
Manufacturer
Navajo Manufacturing Company Inc.
Effective date
2019-11-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Motrin IBNavajo Manufacturing Company Inc.2019-11-27HUMAN OTC DRUG LABEL
Motrin IB - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division2019-07-26HUMAN OTC DRUG LABEL
Motrin IB - Savings Distributors LLCSavings Distributors LLC2019-07-11HUMAN OTC DRUG LABEL
Motrin IB ®Lil' Drug Store Products, Inc.2018-07-05HUMAN OTC DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-110-01EA - Each50580-110867365d4-4425-426f-bf59-46f6dfabd14b12012-07-24
50580-110-02EA - Each50580-11031401772-7c9b-4d71-a279-1ec4a77f095212012-07-24
50580-110-03EA - Each50580-110914bf222-d4b9-4d69-bcff-2e30fd34d5f612012-07-24
50580-110-09EA - Each50580-1101589ab72-c436-43bf-bf25-c883ae326ea212012-07-24
50580-110-19EA - Each50580-11070e17cab-9b09-4dd3-833f-5acdbedda78b12012-07-24
50580-110-37EA - Each50580-11087af4730-f4f3-48ea-a65f-b5c15c0e194c12012-07-24
50580-110-52EA - Each50580-11082dfca75-6914-4194-8717-ea1fd3354c1b12012-07-24
50580-110-60EA - Each50580-1106ea6daa9-b107-4f42-b767-9b0336899dfd12012-07-24
50580-110-62EA - Each50580-1102b192ee9-708a-4776-96db-60c8310b4b8412012-07-24
50580-110-64EA - Each50580-11062c27713-706d-4be9-b73c-34d7ffc2095512012-07-24
50580-110-95EA - Each50580-110d939130b-4e12-4684-a078-d07ccdbfba5212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IbuprofenACTIVE INGREDIENTWK2XYI10QMMOTRIN IB (IBUPROFEN) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]4
IbuprofenACTIVE MOIETYWK2XYI10QMMOTRIN IB (IBUPROFEN) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]4
carnauba waxINACTIVE INGREDIENTR12CBM0EIZMOTRIN IB (IBUPROFEN) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]4
FD&C yellow no. 6INACTIVE INGREDIENTH77VEI93A8MOTRIN IB (IBUPROFEN) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]4
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357MOTRIN IB (IBUPROFEN) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]4
hypromellosesINACTIVE INGREDIENT3NXW29V3WOMOTRIN IB (IBUPROFEN) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]4
magnesium stearateINACTIVE INGREDIENT70097M6I30MOTRIN IB (IBUPROFEN) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]4
polydextroseINACTIVE INGREDIENTVH2XOU12IEMOTRIN IB (IBUPROFEN) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]4
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1AMOTRIN IB (IBUPROFEN) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]4
propylene glycolINACTIVE INGREDIENT6DC9Q167V3MOTRIN IB (IBUPROFEN) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]4
shellacINACTIVE INGREDIENT46N107B71OMOTRIN IB (IBUPROFEN) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]4
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4MOTRIN IB (IBUPROFEN) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]4
starch, cornINACTIVE INGREDIENTO8232NY3SJMOTRIN IB (IBUPROFEN) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]4
stearic acidINACTIVE INGREDIENT4ELV7Z65APMOTRIN IB (IBUPROFEN) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]4
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPMOTRIN IB (IBUPROFEN) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]4
IbuprofenACTIVE INGREDIENTWK2XYI10QMMOTRIN IB (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
IbuprofenACTIVE MOIETYWK2XYI10QMMOTRIN IB (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
carnauba waxINACTIVE INGREDIENTR12CBM0EIZMOTRIN IB (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
FD&C yellow no. 6INACTIVE INGREDIENTH77VEI93A8MOTRIN IB (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
ferric oxide redINACTIVE INGREDIENT1K09F3G675MOTRIN IB (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
hypromellosesINACTIVE INGREDIENT3NXW29V3WOMOTRIN IB (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30MOTRIN IB (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
polydextroseINACTIVE INGREDIENTVH2XOU12IEMOTRIN IB (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1AMOTRIN IB (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3MOTRIN IB (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
shellacINACTIVE INGREDIENT46N107B71OMOTRIN IB (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4MOTRIN IB (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
starch, cornINACTIVE INGREDIENTO8232NY3SJMOTRIN IB (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
stearic acidINACTIVE INGREDIENT4ELV7Z65APMOTRIN IB (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPMOTRIN IB (IBUPROFEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2

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 199 · 3,968 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
dual actionACETAMINOPHEN, IBUPROFENRite Aid Corporation54b08d24-d5e9-4111-9d97-329896e8309d2026-09-09WarningsExact identifier
unii: WK2XYI10QM
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
IbuprofenIBUPROFENLidl US LLC0ca02f8b-4413-4e7c-a67b-8c67c53e13432026-09-09WarningsExact identifier
rxcui: 310965
unii: WK2XYI10QM
IbuprofenIBUPROFENGOODSENSE596a1007-08ea-00ec-e063-6394a90a5eb22026-09-09WarningsExact identifier
unii: WK2XYI10QM
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: 532B59J990
ibuprofen childrensIBUPROFENRite Aid Corporationc6e68886-edcb-414d-9cba-0d97772ef8b62026-09-09WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENREMEDYREPACK INC.2144eff0-d7ab-486d-b116-a4ff3ae2afe22026-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENThe Kroger Co.a7789f7f-3356-463b-9fd7-2d7f7eba27992026-09-08WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENAmazon.com Services LLC90659e83-d989-46a5-9680-3a4f616125112026-09-04WarningsExact identifier
rxcui: 310965
unii: WK2XYI10QM
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
IbuprofenIBUPROFENDirect_Rx40071818-5bf0-095b-e063-6294a90ad58a2026-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
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
IbuprofenIBUPROFENChain Drug Marketing Association, Inc.8d518a08-486a-4d11-b042-27fc1e6060c92026-09-03WarningsExact identifier
rxcui: 310965
unii: WK2XYI10QM
IBUPROFEN Immediate ReleaseIBUPROFENStrides Pharma Inca5dd275f-f388-44ec-8297-74430a742d522026-09-02Boxed warning, WarningsExact identifier
rxcui: 310965
unii: WK2XYI10QM
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.0fa4cd66-66ad-4ec9-b38c-6b5840df39df2026-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Ibuprofen Immediate ReleaseIBUPROFENStrides Pharma Incebcc4da3-d0f6-4e40-99b5-e88310ea4a5b2026-09-02Boxed warning, WarningsExact identifier
rxcui: 310965
unii: WK2XYI10QM
IbuprofenIBUPROFENREMEDYREPACK INC.99730c4a-d2ee-46f5-91f4-a15cbaace40d2026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.3a38add6-a114-4e18-836c-3bfc727db2312026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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