Home NDC 69618-078 Childrens Ibuprofen Oral Suspension
Product NDC 69618-078
11-digit product format 696180078
Labeler code 69618
Product ID 69618-078_2bc7eda7-d97a-e728-e063-6394a90a091e
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen
Dosage form SUSPENSION
Route ORAL
Labeler Reliable 1 Laboratories LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-12-02
Substance IBUPROFEN
Active strength 100 mg/5mL
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Childrens Ibuprofen Oral Suspension
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBUPROFEN 100 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WK2XYI10QM Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197803 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69618-078-54 Childrens Ibuprofen Oral Suspension 118 mL in 1 BOTTLE SUSPENSION 118 2 69618-078-54 Childrens Ibuprofen Oral Suspension 1 in 1 CARTON SUSPENSION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69618-078 CHILDRENS IBUPROFEN ORAL SUSPENSION (IBUPROFEN) SUSPENSION [RELIABLE 1 LABORATORIES LLC] 2 Current NDC, 2 package rows 20250119_28dd9baa-43bd-b60a-e063-6394a90a8cf7.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 69618-078-54 69618007854 1 BOTTLE in 1 CARTON (69618-078-54) / 118 mL in 1 BOTTLE 1 bottle 2024-12-02 No No Current