ibuprofen and diphenhydramine citrate

Generic: ibuprofen and diphenhydramine citrate

Labeler: dr. reddy's laboratories limited
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 dr. reddy's laboratories limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
Dr. Reddy's Laboratories Limited

Identifiers & Regulatory

Product NDC 55111-565
Product ID 55111-565_d2953b94-9244-2c86-ac0c-7610dd1e7963
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA090619
Listing Expiration 2026-12-31
Marketing Start 2010-01-31

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 55111565
Hyphenated Format 55111-565

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 ANDA090619 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 38 mg/1
  • 200 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (55111-565-05) / 500 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (55111-565-14) / 20 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (55111-565-18) / 180 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (55111-565-30) / 30 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (55111-565-40) / 40 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (55111-565-80) / 80 TABLET in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (55111-565-90) / 90 TABLET in 1 BOTTLE
  • 2500 TABLET in 1 POUCH (55111-565-92)
source: ndc

Packages (8)

55111-565-05 1 BOTTLE in 1 CARTON (55111-565-05) / 500 TABLET in 1 BOTTLE 55111-565-14 1 BOTTLE in 1 CARTON (55111-565-14) / 20 TABLET in 1 BOTTLE 55111-565-18 1 BOTTLE in 1 CARTON (55111-565-18) / 180 TABLET in 1 BOTTLE 55111-565-30 1 BOTTLE in 1 CARTON (55111-565-30) / 30 TABLET in 1 BOTTLE 55111-565-40 1 BOTTLE in 1 CARTON (55111-565-40) / 40 TABLET in 1 BOTTLE 55111-565-80 1 BOTTLE in 1 CARTON (55111-565-80) / 80 TABLET in 1 BOTTLE 55111-565-90 1 BOTTLE in 1 CARTON (55111-565-90) / 90 TABLET in 1 BOTTLE 55111-565-92 2500 TABLET in 1 POUCH (55111-565-92)

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": "d2953b94-9244-2c86-ac0c-7610dd1e7963", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["4OD433S209", "WK2XYI10QM"], "rxcui": ["895664"], "spl_set_id": ["42c06daf-541a-7721-b875-ea18364501a4"], "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": ["Dr. Reddy's Laboratories Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (55111-565-05)  / 500 TABLET in 1 BOTTLE", "package_ndc": "55111-565-05", "marketing_start_date": "20100131"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (55111-565-14)  / 20 TABLET in 1 BOTTLE", "package_ndc": "55111-565-14", "marketing_start_date": "20100131"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (55111-565-18)  / 180 TABLET in 1 BOTTLE", "package_ndc": "55111-565-18", "marketing_start_date": "20100131"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (55111-565-30)  / 30 TABLET in 1 BOTTLE", "package_ndc": "55111-565-30", "marketing_start_date": "20100131"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (55111-565-40)  / 40 TABLET in 1 BOTTLE", "package_ndc": "55111-565-40", "marketing_start_date": "20100131"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (55111-565-80)  / 80 TABLET in 1 BOTTLE", "package_ndc": "55111-565-80", "marketing_start_date": "20100131"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (55111-565-90)  / 90 TABLET in 1 BOTTLE", "package_ndc": "55111-565-90", "marketing_start_date": "20100131"}, {"sample": false, "description": "2500 TABLET in 1 POUCH (55111-565-92)", "package_ndc": "55111-565-92", "marketing_start_date": "20100131"}], "brand_name": "Ibuprofen and Diphenhydramine Citrate", "product_id": "55111-565_d2953b94-9244-2c86-ac0c-7610dd1e7963", "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": "55111-565", "generic_name": "Ibuprofen and Diphenhydramine Citrate", "labeler_name": "Dr. Reddy's Laboratories Limited", "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": "ANDA090619", "marketing_category": "ANDA", "marketing_start_date": "20100131", "listing_expiration_date": "20261231"}