ibuprofen infants drops

Generic: ibuprofen

Labeler: discount drug mart, inc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen infants drops
Generic Name ibuprofen
Labeler discount drug mart, inc
Dosage Form SUSPENSION/ DROPS
Routes
ORAL
Active Ingredients

ibuprofen 50 mg/1.25mL

Manufacturer
Discount Drug Mart, Inc

Identifiers & Regulatory

Product NDC 53943-637
Product ID 53943-637_e3a822e2-5d80-4966-9245-6ca09f8b6689
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA210755
Listing Expiration 2026-12-31
Marketing Start 2025-02-13

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 53943637
Hyphenated Format 53943-637

Supplemental Identifiers

RxCUI
204442
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 infants drops (source: ndc)
Generic Name ibuprofen (source: ndc)
Application Number ANDA210755 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1.25mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (53943-637-09) / 30 mL in 1 BOTTLE
source: ndc

Packages (1)

53943-637-09 1 BOTTLE in 1 CARTON (53943-637-09) / 30 mL in 1 BOTTLE

Ingredients (1)

ibuprofen (50 mg/1.25mL)

Linked Drug Pages (1)

Ibuprofen infants Drops ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e3a822e2-5d80-4966-9245-6ca09f8b6689", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["204442"], "spl_set_id": ["2d582242-8b63-b51d-e063-6394a90a979a"], "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": ["Discount Drug Mart, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (53943-637-09)  / 30 mL in 1 BOTTLE", "package_ndc": "53943-637-09", "marketing_start_date": "20250213"}], "brand_name": "Ibuprofen infants Drops", "product_id": "53943-637_e3a822e2-5d80-4966-9245-6ca09f8b6689", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "53943-637", "generic_name": "Ibuprofen", "labeler_name": "Discount Drug Mart, Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ibuprofen infants Drops", "active_ingredients": [{"name": "IBUPROFEN", "strength": "50 mg/1.25mL"}], "application_number": "ANDA210755", "marketing_category": "ANDA", "marketing_start_date": "20250213", "listing_expiration_date": "20261231"}