FDA.reportPublic FDA data

Childrens Novufen Ibuprofen

Product NDC
78307-100
Requested package NDC
78307-100-01
11-digit product format
783070100
Labeler code
78307
Product ID
78307-100_a974aa0e-2e02-2c7d-e053-2a95a90a57d9
Type
HUMAN OTC DRUG
Nonproprietary name
Ibuprofen
Dosage form
SUSPENSION
Route
ORAL
Labeler
NOVUGEN PHARMA LLC
Application
NDA020516
Marketing category
NDA
Marketing start
2020-07-03
Marketing end
0000-00-00
Substance
IBUPROFEN
Active strength
100 mg/5mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage78307-10078307-100-01DDiscontinued by firm2026-07-31

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
Childrens MotrinIBUPROFENKenvue Brands LLC152189e5-391c-42d3-a03b-c8364e2de6bf2024-11-08WarningsExact identifier
application applno (NDA): 020516
application number: NDA020516
Childrens MotrinIBUPROFENKenvue Brands LLC9e1cdef7-921f-4163-869c-6c062e31c5bb2024-11-01WarningsExact identifier
application applno (NDA): 020516
application number: NDA020516
Childrens MOTRINIBUPROFENKenvue Brands LLCf2609308-17bf-4bcb-84b2-d17f3fd359582024-11-01WarningsExact identifier
application applno (NDA): 020516
application number: NDA020516

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78307-100-01783070100011 BOTTLE in 1 CARTON (78307-100-01) > 120 mL in 1 BOTTLE1 bottle2020-07-030000-00-00NoNoCurrent