childrens ibuprofen oral suspension

Generic: ibuprofen

Labeler: reliable 1 laboratories llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name childrens ibuprofen oral suspension
Generic Name ibuprofen
Labeler reliable 1 laboratories llc
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

ibuprofen 100 mg/5mL

Manufacturer
Reliable 1 Laboratories LLC

Identifiers & Regulatory

Product NDC 69618-078
Product ID 69618-078_2bc7eda7-d97a-e728-e063-6394a90a091e
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-12-02

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 69618078
Hyphenated Format 69618-078

Supplemental Identifiers

RxCUI
197803
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 childrens ibuprofen oral suspension (source: ndc)
Generic Name ibuprofen (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (69618-078-54) / 118 mL in 1 BOTTLE
source: ndc

Packages (1)

69618-078-54 1 BOTTLE in 1 CARTON (69618-078-54) / 118 mL in 1 BOTTLE

Ingredients (1)

ibuprofen (100 mg/5mL)

Linked Drug Pages (1)

Childrens Ibuprofen Oral Suspension ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2bc7eda7-d97a-e728-e063-6394a90a091e", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["197803"], "spl_set_id": ["28dd9baa-43bd-b60a-e063-6394a90a8cf7"], "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": ["Reliable 1 Laboratories LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (69618-078-54)  / 118 mL in 1 BOTTLE", "package_ndc": "69618-078-54", "marketing_start_date": "20241202"}], "brand_name": "Childrens Ibuprofen Oral Suspension", "product_id": "69618-078_2bc7eda7-d97a-e728-e063-6394a90a091e", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "69618-078", "generic_name": "Ibuprofen", "labeler_name": "Reliable 1 Laboratories LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Childrens Ibuprofen Oral Suspension", "active_ingredients": [{"name": "IBUPROFEN", "strength": "100 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20241202", "listing_expiration_date": "20261231"}