ibuprofen childrens

Generic: ibuprofen

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

Drug Facts

Product Profile

Brand Name ibuprofen childrens
Generic Name ibuprofen
Labeler fsa store inc. (caring mills)
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

ibuprofen 100 mg/5mL

Manufacturer
FSA Store Inc. (Caring Mills)

Identifiers & Regulatory

Product NDC 81522-700
Product ID 81522-700_086f55c9-08f1-4ea6-ad00-5b1765e3ca03
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA074916
Listing Expiration 2026-12-31
Marketing Start 2022-04-21

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 81522700
Hyphenated Format 81522-700

Supplemental Identifiers

RxCUI
197803
UPC
0349580479043
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 ibuprofen childrens (source: ndc)
Generic Name ibuprofen (source: ndc)
Application Number ANDA074916 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (81522-700-04) / 118 mL in 1 BOTTLE
source: ndc

Packages (1)

81522-700-04 1 BOTTLE in 1 CARTON (81522-700-04) / 118 mL in 1 BOTTLE

Ingredients (1)

ibuprofen (100 mg/5mL)

Linked Drug Pages (1)

Ibuprofen Childrens ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "086f55c9-08f1-4ea6-ad00-5b1765e3ca03", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0349580479043"], "unii": ["WK2XYI10QM"], "rxcui": ["197803"], "spl_set_id": ["6505b0f6-1045-46c5-9ece-4bb38bdb0855"], "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 Mills)"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (81522-700-04)  / 118 mL in 1 BOTTLE", "package_ndc": "81522-700-04", "marketing_start_date": "20220421"}], "brand_name": "Ibuprofen Childrens", "product_id": "81522-700_086f55c9-08f1-4ea6-ad00-5b1765e3ca03", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "81522-700", "generic_name": "Ibuprofen", "labeler_name": "FSA Store Inc. (Caring Mills)", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ibuprofen", "brand_name_suffix": "Childrens", "active_ingredients": [{"name": "IBUPROFEN", "strength": "100 mg/5mL"}], "application_number": "ANDA074916", "marketing_category": "ANDA", "marketing_start_date": "20220421", "listing_expiration_date": "20261231"}