diphenhydramine hcl and ibuprofen

Generic: diphenhydramine hcl and ibuprofen

Labeler: aurohealth llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

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 58602-814
Product ID 58602-814_8cd3b0a3-8a94-4cca-a6a7-f144a826f122
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA210676
Listing Expiration 2026-12-31
Marketing Start 2019-02-14

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 58602814
Hyphenated Format 58602-814

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
  • 1 BOTTLE in 1 CARTON (58602-814-10) / 32 CAPSULE, LIQUID FILLED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-814-12) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-814-18) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE
  • 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (58602-814-23)
  • 160 CAPSULE, LIQUID FILLED in 1 BOTTLE (58602-814-30)
  • 1 BOTTLE in 1 CARTON (58602-814-73) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE
source: ndc

Packages (6)

58602-814-10 1 BOTTLE in 1 CARTON (58602-814-10) / 32 CAPSULE, LIQUID FILLED in 1 BOTTLE 58602-814-12 1 BOTTLE in 1 CARTON (58602-814-12) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE 58602-814-18 1 BOTTLE in 1 CARTON (58602-814-18) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE 58602-814-23 120 CAPSULE, LIQUID FILLED in 1 BOTTLE (58602-814-23) 58602-814-30 160 CAPSULE, LIQUID FILLED in 1 BOTTLE (58602-814-30) 58602-814-73 1 BOTTLE in 1 CARTON (58602-814-73) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE

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": "8cd3b0a3-8a94-4cca-a6a7-f144a826f122", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["TC2D6JAD40", "WK2XYI10QM"], "rxcui": ["901814"], "spl_set_id": ["a656f8b0-8cb4-4802-b8d3-7b95c0265d56"], "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": "1 BOTTLE in 1 CARTON (58602-814-10)  / 32 CAPSULE, LIQUID FILLED in 1 BOTTLE", "package_ndc": "58602-814-10", "marketing_start_date": "20190214"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-814-12)  / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE", "package_ndc": "58602-814-12", "marketing_start_date": "20190214"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-814-18)  / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE", "package_ndc": "58602-814-18", "marketing_start_date": "20190214"}, {"sample": false, "description": "120 CAPSULE, LIQUID FILLED in 1 BOTTLE (58602-814-23)", "package_ndc": "58602-814-23", "marketing_start_date": "20190214"}, {"sample": false, "description": "160 CAPSULE, LIQUID FILLED in 1 BOTTLE (58602-814-30)", "package_ndc": "58602-814-30", "marketing_start_date": "20190214"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-814-73)  / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE", "package_ndc": "58602-814-73", "marketing_start_date": "20190214"}], "brand_name": "Diphenhydramine HCl and Ibuprofen", "product_id": "58602-814_8cd3b0a3-8a94-4cca-a6a7-f144a826f122", "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": "58602-814", "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": "20190214", "listing_expiration_date": "20261231"}