NDC 55758-304

Dolex Children

Ibuprofen

Dolex Children is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Pharmadel Llc. The primary component is Ibuprofen.

Product ID55758-304_ac3c264f-da36-a474-e053-2a95a90abdad
NDC55758-304
Product TypeHuman Otc Drug
Proprietary NameDolex Children
Generic NameIbuprofen
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2020-08-07
Marketing CategoryANDA / ANDA
Application NumberANDA210602
Labeler NamePharmadel LLC
Substance NameIBUPROFEN
Active Ingredient Strength100 mg/100mL
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 55758-304-04

1 BOTTLE in 1 CARTON (55758-304-04) > 118 mL in 1 BOTTLE
Marketing Start Date2020-08-07
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "Dolex Children" or generic name "Ibuprofen"

NDCBrand NameGeneric Name
55758-304Dolex ChildrenDolex Children
0113-1461basic care childrens ibuprofenIbuprofen
0113-7619basic care childrens ibuprofenibuprofen
0113-7660basic care childrens ibuprofenIbuprofen
0113-7897Basic Care childrens ibuprofenIbuprofen
0113-0788Basic Care ibuprofenIbuprofen
0113-7131basic care ibuprofenIbuprofen
0113-7517basic care ibuprofenIbuprofen
0113-7604Basic Care IbuprofenIbuprofen
0121-0917Childrens IbuprofenIbuprofen
0121-0914Childrens Ibuprofen Oral SuspensionIbuprofen
0113-2461Good Sense Childrens IbuprofenIbuprofen
0113-0057Good Sense ibuprofenibuprofen
0113-0074Good Sense ibuprofenIbuprofen
0113-0166good sense ibuprofenIbuprofen
0113-0298good sense ibuprofenIbuprofen
0113-0461Good Sense ibuprofenIbuprofen
0113-0517Good Sense ibuprofenIbuprofen
0113-0604good sense ibuprofenIbuprofen
0113-0647good sense ibuprofenIbuprofen
0113-0660Good Sense IbuprofenIbuprofen
0113-0685Good Sense IbuprofenIbuprofen
0113-0897good sense ibuprofenIbuprofen
0113-1212Good Sense IbuprofenIbuprofen
0113-4501good sense ibuprofenibuprofen
0113-0040Good Sense Infants IbuprofenIbuprofen

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