ibuprofen 200 mg and diphenhydramine citrate 38 mg

Generic: ibuprofen, diphenhydramine citrate

Labeler: pld acquisitions llc dba avma pharma solutions
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen 200 mg and diphenhydramine citrate 38 mg
Generic Name ibuprofen, diphenhydramine citrate
Labeler pld acquisitions llc dba avma pharma solutions
Dosage Form TABLET
Routes
ORAL
Active Ingredients

diphenhydramine citrate 38 mg/1, ibuprofen 200 mg/1

Manufacturer
PLD Acquisitions LLC DBA Avma Pharma Solutions

Identifiers & Regulatory

Product NDC 63548-0197
Product ID 63548-0197_fbc47d79-348d-436e-ae3f-364d76f58e49
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA211404
Listing Expiration 2026-12-31
Marketing Start 2024-04-11

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 635480197
Hyphenated Format 63548-0197

Supplemental Identifiers

RxCUI
895664
UPC
0000000000000
UNII
4OD433S209 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 200 mg and diphenhydramine citrate 38 mg (source: ndc)
Generic Name ibuprofen, diphenhydramine citrate (source: ndc)
Application Number ANDA211404 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 38 mg/1
  • 200 mg/1
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 BOX (63548-0197-2) / 20 TABLET in 1 BOTTLE, PLASTIC
  • 300 TABLET in 1 BOTTLE, PLASTIC (63548-0197-3)
  • 8 TABLET in 1 BOTTLE, PLASTIC (63548-0197-8)
source: ndc

Packages (3)

63548-0197-2 1 BOTTLE, PLASTIC in 1 BOX (63548-0197-2) / 20 TABLET in 1 BOTTLE, PLASTIC 63548-0197-3 300 TABLET in 1 BOTTLE, PLASTIC (63548-0197-3) 63548-0197-8 8 TABLET in 1 BOTTLE, PLASTIC (63548-0197-8)

Ingredients (2)

diphenhydramine citrate (38 mg/1) ibuprofen (200 mg/1)

Linked Drug Pages (1)

Ibuprofen 200 mg and Diphenhydramine Citrate 38 mg ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "fbc47d79-348d-436e-ae3f-364d76f58e49", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0000000000000"], "unii": ["4OD433S209", "WK2XYI10QM"], "rxcui": ["895664"], "spl_set_id": ["a7d729bf-6d7a-415a-a414-cae0ba6d0063"], "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": ["PLD Acquisitions LLC DBA Avma Pharma Solutions"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 BOX (63548-0197-2)  / 20 TABLET in 1 BOTTLE, PLASTIC", "package_ndc": "63548-0197-2", "marketing_start_date": "20240411"}, {"sample": false, "description": "300 TABLET in 1 BOTTLE, PLASTIC (63548-0197-3)", "package_ndc": "63548-0197-3", "marketing_start_date": "20240411"}, {"sample": false, "description": "8 TABLET in 1 BOTTLE, PLASTIC (63548-0197-8)", "package_ndc": "63548-0197-8", "marketing_start_date": "20240411"}], "brand_name": "Ibuprofen 200 mg and Diphenhydramine Citrate 38 mg", "product_id": "63548-0197_fbc47d79-348d-436e-ae3f-364d76f58e49", "dosage_form": "TABLET", "pharm_class": ["Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitors [MoA]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "Nonsteroidal Anti-inflammatory Drug [EPC]"], "product_ndc": "63548-0197", "generic_name": "Ibuprofen, Diphenhydramine Citrate", "labeler_name": "PLD Acquisitions LLC DBA Avma Pharma Solutions", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ibuprofen 200 mg and Diphenhydramine Citrate 38 mg", "active_ingredients": [{"name": "DIPHENHYDRAMINE CITRATE", "strength": "38 mg/1"}, {"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA211404", "marketing_category": "ANDA", "marketing_start_date": "20240411", "listing_expiration_date": "20261231"}