childrens ibuprofen oral suspension dye free

Generic: ibuprofen

Labeler: fsa store inc. (caring mill)
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name childrens ibuprofen oral suspension dye free
Generic Name ibuprofen
Labeler fsa store inc. (caring mill)
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

ibuprofen 100 mg/5mL

Manufacturer
FSA Store Inc. (Caring Mill)

Identifiers & Regulatory

Product NDC 81522-311
Product ID 81522-311_720d2ca9-e3f4-4d00-8d75-2849b51f3553
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA210602
Listing Expiration 2026-12-31
Marketing Start 2025-09-05

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 81522311
Hyphenated Format 81522-311

Supplemental Identifiers

RxCUI
197803
UPC
4280077929022
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 dye free (source: ndc)
Generic Name ibuprofen (source: ndc)
Application Number ANDA210602 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (81522-311-11) / 118 mL in 1 BOTTLE
source: ndc

Packages (1)

81522-311-11 1 BOTTLE in 1 CARTON (81522-311-11) / 118 mL in 1 BOTTLE

Ingredients (1)

ibuprofen (100 mg/5mL)

Linked Drug Pages (1)

Childrens Ibuprofen Oral Suspension Dye Free ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "720d2ca9-e3f4-4d00-8d75-2849b51f3553", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["4280077929022"], "unii": ["WK2XYI10QM"], "rxcui": ["197803"], "spl_set_id": ["099e374b-49c2-4d56-a047-d4f0c4af34ba"], "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": ["FSA Store Inc. (Caring Mill)"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (81522-311-11)  / 118 mL in 1 BOTTLE", "package_ndc": "81522-311-11", "marketing_start_date": "20250905"}], "brand_name": "Childrens Ibuprofen Oral Suspension Dye Free", "product_id": "81522-311_720d2ca9-e3f4-4d00-8d75-2849b51f3553", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "81522-311", "generic_name": "IBUPROFEN", "labeler_name": "FSA Store Inc. (Caring Mill)", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Childrens Ibuprofen Oral Suspension Dye Free", "active_ingredients": [{"name": "IBUPROFEN", "strength": "100 mg/5mL"}], "application_number": "ANDA210602", "marketing_category": "ANDA", "marketing_start_date": "20250905", "listing_expiration_date": "20261231"}