diphenhydramine hcl and ibuprofen (58602-717)

Drug Facts

Product Profile

Brand Name diphenhydramine hcl and ibuprofen

Generic Name diphenhydramine hcl and ibuprofen

Labeler aurohealth llc

Dosage Form CAPSULE, LIQUID FILLED

Routes

ORAL

Active Ingredients

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

Manufacturer

Aurohealth LLC

Identifiers & Regulatory

Product NDC 58602-717

Product ID 58602-717_39af6dfa-e822-43a5-bd1a-338cf5da89ce

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA210676

Listing Expiration 2026-12-31

Marketing Start 2022-12-09

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 58602717

Hyphenated Format 58602-717

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 diphenhydramine hcl and ibuprofen (source: ndc)

Generic Name diphenhydramine hcl and ibuprofen (source: ndc)

Application Number ANDA210676 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

25 mg/1
200 mg/1

source: ndc

Packaging

160 CAPSULE, LIQUID FILLED in 1 BOTTLE (58602-717-30)

source: ndc

Packages (1)

58602-717-30 160 CAPSULE, LIQUID FILLED in 1 BOTTLE (58602-717-30)

Ingredients (2)

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

Linked Drug Pages (1)

Diphenhydramine HCl and Ibuprofen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "39af6dfa-e822-43a5-bd1a-338cf5da89ce", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["TC2D6JAD40", "WK2XYI10QM"], "rxcui": ["901814"], "spl_set_id": ["39af6dfa-e822-43a5-bd1a-338cf5da89ce"], "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": ["Aurohealth LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "160 CAPSULE, LIQUID FILLED in 1 BOTTLE (58602-717-30)", "package_ndc": "58602-717-30", "marketing_start_date": "20221209"}], "brand_name": "Diphenhydramine HCl and Ibuprofen", "product_id": "58602-717_39af6dfa-e822-43a5-bd1a-338cf5da89ce", "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": "58602-717", "generic_name": "Diphenhydramine HCl and Ibuprofen", "labeler_name": "Aurohealth LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Diphenhydramine HCl and Ibuprofen", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}, {"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA210676", "marketing_category": "ANDA", "marketing_start_date": "20221209", "listing_expiration_date": "20261231"}