childrens ibuprofen blue raspberry

Generic: ibuprofen

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

Drug Facts

Product Profile

Brand Name childrens ibuprofen blue raspberry
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 53041-638
Product ID 53041-638_e690a788-b856-44b3-afff-bb950d1eb117
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA210149
Listing Expiration 2026-12-31
Marketing Start 2021-10-13

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 53041638
Hyphenated Format 53041-638

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 blue raspberry (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 (53041-638-03) / 120 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (53041-638-04) / 240 mL in 1 BOTTLE
source: ndc

Packages (2)

53041-638-03 1 BOTTLE in 1 CARTON (53041-638-03) / 120 mL in 1 BOTTLE 53041-638-04 1 BOTTLE in 1 CARTON (53041-638-04) / 240 mL in 1 BOTTLE

Ingredients (1)

ibuprofen (100 mg/5mL)

Linked Drug Pages (1)

Childrens Ibuprofen bubblegum, Childrens Ibuprofen fruit, Childrens Ibuprofen blue raspberry, Childrens Ibuprofen grape ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e690a788-b856-44b3-afff-bb950d1eb117", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["WK2XYI10QM"], "rxcui": ["197803"], "spl_set_id": ["9cb92af9-a829-4f54-b8f5-4e5cb4f165b7"], "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 (53041-638-03)  / 120 mL in 1 BOTTLE", "package_ndc": "53041-638-03", "marketing_start_date": "20211013"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (53041-638-04)  / 240 mL in 1 BOTTLE", "package_ndc": "53041-638-04", "marketing_start_date": "20211013"}], "brand_name": "Childrens Ibuprofen blue raspberry", "product_id": "53041-638_e690a788-b856-44b3-afff-bb950d1eb117", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "53041-638", "generic_name": "Ibuprofen", "labeler_name": "Guardian Drug Company", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Childrens Ibuprofen blue raspberry", "active_ingredients": [{"name": "IBUPROFEN", "strength": "100 mg/5mL"}], "application_number": "ANDA210149", "marketing_category": "ANDA", "marketing_start_date": "20211013", "listing_expiration_date": "20261231"}