ibuprofen, diphenhydramine hcl

Generic: ibuprofen, diphenhydramine hcl

Labeler: bionpharma inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen, diphenhydramine hcl
Generic Name ibuprofen, diphenhydramine hcl
Labeler bionpharma inc.
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

diphenhydramine hydrochloride 25 mg/1, ibuprofen 200 mg/1

Manufacturer
Bionpharma Inc.

Identifiers & Regulatory

Product NDC 69452-205
Product ID 69452-205_0f6b5911-edb2-4e3a-b121-45c609b4c60e
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA090397
Listing Expiration 2026-12-31
Marketing Start 2018-11-01

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 69452205
Hyphenated Format 69452-205

Supplemental Identifiers

RxCUI
901814
UNII
TC2D6JAD40 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, diphenhydramine hcl (source: ndc)
Generic Name ibuprofen, diphenhydramine hcl (source: ndc)
Application Number ANDA090397 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
  • 200 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (69452-205-04) / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
  • 20 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-205-11)
  • 40 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-205-15)
  • 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-205-20)
  • 80 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-205-78)
source: ndc

Packages (5)

69452-205-04 1 BLISTER PACK in 1 CARTON (69452-205-04) / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 69452-205-11 20 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-205-11) 69452-205-15 40 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-205-15) 69452-205-20 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-205-20) 69452-205-78 80 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-205-78)

Ingredients (2)

diphenhydramine hydrochloride (25 mg/1) ibuprofen (200 mg/1)

Linked Drug Pages (1)

IBUPROFEN, DIPHENHYDRAMINE HCL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "0f6b5911-edb2-4e3a-b121-45c609b4c60e", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["TC2D6JAD40", "WK2XYI10QM"], "rxcui": ["901814"], "spl_set_id": ["59a97c31-db90-48e1-ac1b-0f7026c8ec94"], "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": ["Bionpharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (69452-205-04)  / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "69452-205-04", "marketing_start_date": "20181101"}, {"sample": false, "description": "20 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-205-11)", "package_ndc": "69452-205-11", "marketing_start_date": "20181101"}, {"sample": false, "description": "40 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-205-15)", "package_ndc": "69452-205-15", "marketing_start_date": "20181101"}, {"sample": false, "description": "100 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-205-20)", "package_ndc": "69452-205-20", "marketing_start_date": "20181101"}, {"sample": false, "description": "80 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-205-78)", "package_ndc": "69452-205-78", "marketing_start_date": "20181101"}], "brand_name": "IBUPROFEN, DIPHENHYDRAMINE HCL", "product_id": "69452-205_0f6b5911-edb2-4e3a-b121-45c609b4c60e", "dosage_form": "CAPSULE, LIQUID FILLED", "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": "69452-205", "generic_name": "IBUPROFEN, DIPHENHYDRAMINE HCL", "labeler_name": "Bionpharma Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "IBUPROFEN, DIPHENHYDRAMINE HCL", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}, {"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA090397", "marketing_category": "ANDA", "marketing_start_date": "20181101", "listing_expiration_date": "20261231"}