dolex children

Generic: ibuprofen

Labeler: pharmadel llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dolex children
Generic Name ibuprofen
Labeler pharmadel llc
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

ibuprofen 100 mg/100mL

Manufacturer
Pharmadel LLC

Identifiers & Regulatory

Product NDC 55758-304
Product ID 55758-304_ac3c264f-da36-a474-e053-2a95a90abdad
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA210602
Listing Expiration 2026-12-31
Marketing Start 2020-08-07

Pharmacologic Class

Established (EPC)
nonsteroidal anti-inflammatory drug [epc]
Mechanism of Action
cyclooxygenase inhibitors [moa]
Chemical Structure
anti-inflammatory agents, non-steroidal [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55758304
Hyphenated Format 55758-304

Supplemental Identifiers

UNII
WK2XYI10QM
NUI
N0000000160 M0001335 N0000175722

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name dolex children (source: ndc)
Generic Name ibuprofen (source: ndc)
Application Number ANDA210602 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/100mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (55758-304-04) / 118 mL in 1 BOTTLE
source: ndc

Packages (1)

55758-304-04 1 BOTTLE in 1 CARTON (55758-304-04) / 118 mL in 1 BOTTLE

Ingredients (1)

ibuprofen (100 mg/100mL)

Linked Drug Pages (1)

Dolex Children ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ac3c264f-da36-a474-e053-2a95a90abdad", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "spl_set_id": ["ac3c264f-da37-a474-e053-2a95a90abdad"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]"], "manufacturer_name": ["Pharmadel LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (55758-304-04)  / 118 mL in 1 BOTTLE", "package_ndc": "55758-304-04", "marketing_start_date": "20200807"}], "brand_name": "Dolex Children", "product_id": "55758-304_ac3c264f-da36-a474-e053-2a95a90abdad", "dosage_form": "LIQUID", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "55758-304", "generic_name": "Ibuprofen", "labeler_name": "Pharmadel LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Dolex Children", "active_ingredients": [{"name": "IBUPROFEN", "strength": "100 mg/100mL"}], "application_number": "ANDA210602", "marketing_category": "ANDA", "marketing_start_date": "20200807", "listing_expiration_date": "20261231"}