ibuprofen pm

Generic: diphenhydramine citrate, ibuprofen

Labeler: wr group, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen pm
Generic Name diphenhydramine citrate, ibuprofen
Labeler wr group, inc.
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
WR Group, Inc.

Identifiers & Regulatory

Product NDC 69607-1970
Product ID 69607-1970_53818277-b127-4271-9604-8015eacd6c99
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA211404
Listing Expiration 2026-12-31
Marketing Start 2025-02-28

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 696071970
Hyphenated Format 69607-1970

Supplemental Identifiers

RxCUI
895664
UPC
0811079036964
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 pm (source: ndc)
Generic Name diphenhydramine citrate, ibuprofen (source: ndc)
Application Number ANDA211404 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 38 mg/1
  • 200 mg/1
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 BOX (69607-1970-1) / 120 TABLET, COATED in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

69607-1970-1 1 BOTTLE, PLASTIC in 1 BOX (69607-1970-1) / 120 TABLET, COATED in 1 BOTTLE, PLASTIC

Ingredients (2)

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

Linked Drug Pages (1)

Ibuprofen PM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "53818277-b127-4271-9604-8015eacd6c99", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "upc": ["0811079036964"], "unii": ["4OD433S209", "WK2XYI10QM"], "rxcui": ["895664"], "spl_set_id": ["1e2feaf0-7fff-43d5-bcfe-9f2851bdc805"], "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": ["WR Group, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 BOX (69607-1970-1)  / 120 TABLET, COATED in 1 BOTTLE, PLASTIC", "package_ndc": "69607-1970-1", "marketing_start_date": "20250228"}], "brand_name": "Ibuprofen PM", "product_id": "69607-1970_53818277-b127-4271-9604-8015eacd6c99", "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": "69607-1970", "generic_name": "Diphenhydramine Citrate, Ibuprofen", "labeler_name": "WR Group, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ibuprofen PM", "active_ingredients": [{"name": "DIPHENHYDRAMINE CITRATE", "strength": "38 mg/1"}, {"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA211404", "marketing_category": "ANDA", "marketing_start_date": "20250228", "listing_expiration_date": "20261231"}