childrens ibuprofen

Generic: ibuprofen

Labeler: guardian drug company
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name childrens ibuprofen
Generic Name ibuprofen
Labeler guardian drug company
Dosage Form SUSPENSION/ DROPS
Routes
ORAL
Active Ingredients

ibuprofen 100 mg/5mL

Manufacturer
Guardian Drug Company

Identifiers & Regulatory

Product NDC 53041-634
Product ID 53041-634_510c1692-f23a-497b-8738-4b29e7c549e8
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA210149
Listing Expiration 2026-12-31
Marketing Start 2018-08-21

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 53041634
Hyphenated Format 53041-634

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 ANDA210149 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (53041-634-03) / 120 mL in 1 BOTTLE
source: ndc

Packages (1)

53041-634-03 1 BOTTLE in 1 CARTON (53041-634-03) / 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": "510c1692-f23a-497b-8738-4b29e7c549e8", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["197803"], "spl_set_id": ["694866ce-c419-4b4c-bfb2-4175703d89f1"], "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": ["Guardian Drug Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (53041-634-03)  / 120 mL in 1 BOTTLE", "package_ndc": "53041-634-03", "marketing_start_date": "20180821"}], "brand_name": "Childrens Ibuprofen", "product_id": "53041-634_510c1692-f23a-497b-8738-4b29e7c549e8", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "53041-634", "generic_name": "Ibuprofen", "labeler_name": "Guardian Drug Company", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Childrens Ibuprofen", "active_ingredients": [{"name": "IBUPROFEN", "strength": "100 mg/5mL"}], "application_number": "ANDA210149", "marketing_category": "ANDA", "marketing_start_date": "20180821", "listing_expiration_date": "20261231"}