FDA.reportPublic FDA data

Application 020516

Type
NDA
Sponsor
J AND J CONSUMER INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CHILDREN'S MOTRINIBUPROFENSUSPENSION;ORAL100MG/5MLYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020516-001CHILDREN'S MOTRINIBUPROFEN100MG/5MLSUSPENSION / ORALRLD, RS1995-06-16

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N020516-001CHILDREN'S MOTRIN100MG/5MLSUSPENSION / ORALRLD, RS1995-06-16a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens MotrinIBUPROFENKenvue Brands LLC4f664479-f68c-464a-956d-25bb9f39c4cc2024-11-08WarningsExact identifier
application applno (NDA): 020516
application number: NDA020516
ndc (product): 50580-603
Childrens MotrinIBUPROFENKenvue Brands LLC152189e5-391c-42d3-a03b-c8364e2de6bf2024-11-08WarningsExact identifier
application applno (NDA): 020516
application number: NDA020516
ndc (product): 50580-604
Childrens MotrinIBUPROFENKenvue Brands LLC9e1cdef7-921f-4163-869c-6c062e31c5bb2024-11-01WarningsExact identifier
application applno (NDA): 020516
application number: NDA020516
ndc (product): 50580-184
Childrens MOTRINIBUPROFENKenvue Brands LLCf2609308-17bf-4bcb-84b2-d17f3fd359582024-11-01WarningsExact identifier
application applno (NDA): 020516
application number: NDA020516
ndc (product): 50580-601

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
44237-041Childrens Novex IbuprofenIbuprofenHerbion Pakistan (Pvt.) LtdNDACurrent
50580-184Childrens MotrinIbuprofenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-184Childrens MotrinIbuprofenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-184Childrens MotrinIbuprofenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-184Childrens MotrinIbuprofenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-184Childrens MotrinIbuprofenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-601Childrens MOTRINIbuprofenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-601Childrens MOTRINIbuprofenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-601Childrens MOTRINIbuprofenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-601Childrens MOTRINIbuprofenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-601Childrens MOTRINIbuprofenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-603Childrens MotrinIbuprofenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-603Childrens MotrinIbuprofenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-603Childrens MotrinIbuprofenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-604Childrens MotrinIbuprofenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-604Childrens MotrinIbuprofenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-604Childrens MotrinIbuprofenJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
78307-100Childrens Novufen IbuprofenIbuprofenNOVUGEN PHARMA LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67994SUPPL2021-06-30
67827SUPPL2021-06-16
56811SUPPL2018-12-19
56613SUPPL2018-12-03
47607SUPPL2017-03-20
47569SUPPL2017-03-16
34743SUPPL2016-06-22
25083SUPPL2016-06-21
12664SUPPL2015-04-21
2642SUPPL2015-04-17
34742SUPPL2014-12-19
2641SUPPL2014-12-12
25082SUPPL2011-12-08
25081SUPPL2010-10-22
2640SUPPL2009-05-06
2639SUPPL2006-06-28
2638SUPPL2005-12-15
2637SUPPL2005-02-09
2636SUPPL2003-12-23
2635SUPPL2003-10-31
20691SUPPL1999-09-13
12663SUPPL1999-09-13
2634SUPPL1999-09-13