pediacare childrens ibuprofen berry

Generic: ibuprofen

Labeler: randob labs,ltd. dba crossingwell consumer health
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pediacare childrens ibuprofen berry
Generic Name ibuprofen
Labeler randob labs,ltd. dba crossingwell consumer health
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

ibuprofen 100 mg/5mL

Manufacturer
RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH

Identifiers & Regulatory

Product NDC 52412-910
Product ID 52412-910_3cd2cd8d-d5cd-4eaf-9e60-980a7f62a3b8
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA210602
Listing Expiration 2026-12-31
Marketing Start 2023-01-03

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 52412910
Hyphenated Format 52412-910

Supplemental Identifiers

RxCUI
197803
UPC
0030103091001
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 pediacare childrens ibuprofen berry (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 (52412-910-04) / 118 mL in 1 BOTTLE
source: ndc

Packages (1)

52412-910-04 1 BOTTLE in 1 CARTON (52412-910-04) / 118 mL in 1 BOTTLE

Ingredients (1)

ibuprofen (100 mg/5mL)

Linked Drug Pages (1)

Pediacare Childrens Ibuprofen Berry ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3cd2cd8d-d5cd-4eaf-9e60-980a7f62a3b8", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0030103091001"], "unii": ["WK2XYI10QM"], "rxcui": ["197803"], "spl_set_id": ["347d081f-068c-4173-9b4b-001ab2b891f5"], "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. DBA CROSSINGWELL CONSUMER HEALTH"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (52412-910-04)  / 118 mL in 1 BOTTLE", "package_ndc": "52412-910-04", "marketing_start_date": "20230103"}], "brand_name": "Pediacare Childrens Ibuprofen Berry", "product_id": "52412-910_3cd2cd8d-d5cd-4eaf-9e60-980a7f62a3b8", "dosage_form": "SUSPENSION", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "52412-910", "generic_name": "IBUPROFEN", "labeler_name": "RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Pediacare Childrens Ibuprofen Berry", "active_ingredients": [{"name": "IBUPROFEN", "strength": "100 mg/5mL"}], "application_number": "ANDA210602", "marketing_category": "ANDA", "marketing_start_date": "20230103", "listing_expiration_date": "20261231"}