ibuprofen and diphenhydramine citrate

Generic: ibuprofen and diphenhydramine citrate

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

Drug Facts

Product Profile

Brand Name ibuprofen and diphenhydramine citrate
Generic Name ibuprofen and diphenhydramine citrate
Labeler aurohealth llc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
Aurohealth LLC

Identifiers & Regulatory

Product NDC 58602-867
Product ID 58602-867_21c1f5c5-19fa-4a59-bad3-ea85fd37471b
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA216204
Listing Expiration 2026-12-31
Marketing Start 2022-05-31

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 58602867
Hyphenated Format 58602-867

Supplemental Identifiers

RxCUI
895664
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 and diphenhydramine citrate (source: ndc)
Generic Name ibuprofen and diphenhydramine citrate (source: ndc)
Application Number ANDA216204 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 38 mg/1
  • 200 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (58602-867-09) / 30 TABLET, COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-867-12) / 40 TABLET, COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-867-14) / 50 TABLET, COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-867-18) / 80 TABLET, COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-867-21) / 100 TABLET, COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (58602-867-23) / 120 TABLET, COATED in 1 BOTTLE
  • 140 TABLET, COATED in 1 BOTTLE (58602-867-27)
  • 180 TABLET, COATED in 1 BOTTLE (58602-867-32)
  • 200 TABLET, COATED in 1 BOTTLE (58602-867-34)
  • 140 TABLET, COATED in 1 BOTTLE, PLASTIC (58602-867-46)
  • 1 BOTTLE, PLASTIC in 1 CARTON (58602-867-70) / 40 TABLET, COATED in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (58602-867-72) / 80 TABLET, COATED in 1 BOTTLE, PLASTIC
  • 1 BOTTLE in 1 CARTON (58602-867-73) / 20 TABLET, COATED in 1 BOTTLE
  • 1 BOTTLE, PLASTIC in 1 CARTON (58602-867-78) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC
  • 200 TABLET, COATED in 1 BOTTLE, PLASTIC (58602-867-80)
  • 180 TABLET, COATED in 1 BOTTLE, PLASTIC (58602-867-92)
  • 120 TABLET, COATED in 1 BOTTLE, PLASTIC (58602-867-97)
source: ndc

Packages (17)

58602-867-09 1 BOTTLE in 1 CARTON (58602-867-09) / 30 TABLET, COATED in 1 BOTTLE 58602-867-12 1 BOTTLE in 1 CARTON (58602-867-12) / 40 TABLET, COATED in 1 BOTTLE 58602-867-14 1 BOTTLE in 1 CARTON (58602-867-14) / 50 TABLET, COATED in 1 BOTTLE 58602-867-18 1 BOTTLE in 1 CARTON (58602-867-18) / 80 TABLET, COATED in 1 BOTTLE 58602-867-21 1 BOTTLE in 1 CARTON (58602-867-21) / 100 TABLET, COATED in 1 BOTTLE 58602-867-23 1 BOTTLE in 1 CARTON (58602-867-23) / 120 TABLET, COATED in 1 BOTTLE 58602-867-27 140 TABLET, COATED in 1 BOTTLE (58602-867-27) 58602-867-32 180 TABLET, COATED in 1 BOTTLE (58602-867-32) 58602-867-34 200 TABLET, COATED in 1 BOTTLE (58602-867-34) 58602-867-46 140 TABLET, COATED in 1 BOTTLE, PLASTIC (58602-867-46) 58602-867-70 1 BOTTLE, PLASTIC in 1 CARTON (58602-867-70) / 40 TABLET, COATED in 1 BOTTLE, PLASTIC 58602-867-72 1 BOTTLE, PLASTIC in 1 CARTON (58602-867-72) / 80 TABLET, COATED in 1 BOTTLE, PLASTIC 58602-867-73 1 BOTTLE in 1 CARTON (58602-867-73) / 20 TABLET, COATED in 1 BOTTLE 58602-867-78 1 BOTTLE, PLASTIC in 1 CARTON (58602-867-78) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC 58602-867-80 200 TABLET, COATED in 1 BOTTLE, PLASTIC (58602-867-80) 58602-867-92 180 TABLET, COATED in 1 BOTTLE, PLASTIC (58602-867-92) 58602-867-97 120 TABLET, COATED in 1 BOTTLE, PLASTIC (58602-867-97)

Ingredients (2)

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

Linked Drug Pages (1)

Ibuprofen and Diphenhydramine Citrate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "21c1f5c5-19fa-4a59-bad3-ea85fd37471b", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["4OD433S209", "WK2XYI10QM"], "rxcui": ["895664"], "spl_set_id": ["21c1f5c5-19fa-4a59-bad3-ea85fd37471b"], "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 (58602-867-09)  / 30 TABLET, COATED in 1 BOTTLE", "package_ndc": "58602-867-09", "marketing_start_date": "20220531"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-867-12)  / 40 TABLET, COATED in 1 BOTTLE", "package_ndc": "58602-867-12", "marketing_start_date": "20220531"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-867-14)  / 50 TABLET, COATED in 1 BOTTLE", "package_ndc": "58602-867-14", "marketing_start_date": "20220531"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-867-18)  / 80 TABLET, COATED in 1 BOTTLE", "package_ndc": "58602-867-18", "marketing_start_date": "20220531"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-867-21)  / 100 TABLET, COATED in 1 BOTTLE", "package_ndc": "58602-867-21", "marketing_start_date": "20220531"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-867-23)  / 120 TABLET, COATED in 1 BOTTLE", "package_ndc": "58602-867-23", "marketing_start_date": "20220531"}, {"sample": false, "description": "140 TABLET, COATED in 1 BOTTLE (58602-867-27)", "package_ndc": "58602-867-27", "marketing_start_date": "20220531"}, {"sample": false, "description": "180 TABLET, COATED in 1 BOTTLE (58602-867-32)", "package_ndc": "58602-867-32", "marketing_start_date": "20220531"}, {"sample": false, "description": "200 TABLET, COATED in 1 BOTTLE (58602-867-34)", "package_ndc": "58602-867-34", "marketing_start_date": "20220531"}, {"sample": false, "description": "140 TABLET, COATED in 1 BOTTLE, PLASTIC (58602-867-46)", "package_ndc": "58602-867-46", "marketing_start_date": "20220531"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (58602-867-70)  / 40 TABLET, COATED in 1 BOTTLE, PLASTIC", "package_ndc": "58602-867-70", "marketing_start_date": "20220531"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (58602-867-72)  / 80 TABLET, COATED in 1 BOTTLE, PLASTIC", "package_ndc": "58602-867-72", "marketing_start_date": "20220531"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (58602-867-73)  / 20 TABLET, COATED in 1 BOTTLE", "package_ndc": "58602-867-73", "marketing_start_date": "20220531"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (58602-867-78)  / 50 TABLET, COATED in 1 BOTTLE, PLASTIC", "package_ndc": "58602-867-78", "marketing_start_date": "20220531"}, {"sample": false, "description": "200 TABLET, COATED in 1 BOTTLE, PLASTIC (58602-867-80)", "package_ndc": "58602-867-80", "marketing_start_date": "20220531"}, {"sample": false, "description": "180 TABLET, COATED in 1 BOTTLE, PLASTIC (58602-867-92)", "package_ndc": "58602-867-92", "marketing_start_date": "20220531"}, {"sample": false, "description": "120 TABLET, COATED in 1 BOTTLE, PLASTIC (58602-867-97)", "package_ndc": "58602-867-97", "marketing_start_date": "20220531"}], "brand_name": "Ibuprofen and Diphenhydramine Citrate", "product_id": "58602-867_21c1f5c5-19fa-4a59-bad3-ea85fd37471b", "dosage_form": "TABLET, COATED", "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": "58602-867", "generic_name": "Ibuprofen and Diphenhydramine Citrate", "labeler_name": "Aurohealth LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ibuprofen and Diphenhydramine Citrate", "active_ingredients": [{"name": "DIPHENHYDRAMINE CITRATE", "strength": "38 mg/1"}, {"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA216204", "marketing_category": "ANDA", "marketing_start_date": "20220531", "listing_expiration_date": "20261231"}