childrens ibuprofen

Generic: ibuprofen

Labeler: randob labs., ltd.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name childrens ibuprofen
Generic Name ibuprofen
Labeler randob labs., ltd.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

ibuprofen 100 mg/5mL

Manufacturer
Randob Labs., Ltd.

Identifiers & Regulatory

Product NDC 52412-911
Product ID 52412-911_d97115c6-f191-4faa-8e74-3e8817e4a48f
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA209179
Listing Expiration 2026-12-31
Marketing Start 2023-07-15

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 52412911
Hyphenated Format 52412-911

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 (source: ndc)
Generic Name ibuprofen (source: ndc)
Application Number ANDA209179 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (52412-911-04) / 120 mL in 1 BOTTLE
source: ndc

Packages (1)

52412-911-04 1 BOTTLE in 1 CARTON (52412-911-04) / 120 mL in 1 BOTTLE

Ingredients (1)

ibuprofen (100 mg/5mL)

Linked Drug Pages (1)

CHILDRENS IBUPROFEN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d97115c6-f191-4faa-8e74-3e8817e4a48f", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["197803"], "spl_set_id": ["50d6bf9d-ae37-4af3-bfeb-cc0abf8cb094"], "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": ["Randob Labs., Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (52412-911-04)  / 120 mL in 1 BOTTLE", "package_ndc": "52412-911-04", "marketing_start_date": "20230715"}], "brand_name": "CHILDRENS IBUPROFEN", "product_id": "52412-911_d97115c6-f191-4faa-8e74-3e8817e4a48f", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "52412-911", "generic_name": "Ibuprofen", "labeler_name": "Randob Labs., Ltd.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "CHILDRENS IBUPROFEN", "active_ingredients": [{"name": "IBUPROFEN", "strength": "100 mg/5mL"}], "application_number": "ANDA209179", "marketing_category": "ANDA", "marketing_start_date": "20230715", "listing_expiration_date": "20261231"}