ibuprofen and diphenhydramine hcl

Generic: ibuprofen, diphenhydramine hcl

Labeler: valu merchandisers company
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ibuprofen and diphenhydramine hcl
Generic Name ibuprofen, diphenhydramine hcl
Labeler valu merchandisers company
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

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

Manufacturer
VALU MERCHANDISERS COMPANY

Identifiers & Regulatory

Product NDC 63941-682
Product ID 63941-682_06d3d2fc-a073-863f-e063-6394a90a2374
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA090397
Listing Expiration 2026-12-31
Marketing Start 2023-10-03

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 63941682
Hyphenated Format 63941-682

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 ibuprofen and diphenhydramine hcl (source: ndc)
Generic Name ibuprofen, diphenhydramine hcl (source: ndc)
Application Number ANDA090397 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
  • 200 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (63941-682-15) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE
source: ndc

Packages (1)

63941-682-15 1 BOTTLE in 1 CARTON (63941-682-15) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE

Ingredients (2)

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

Linked Drug Pages (1)

Ibuprofen and Diphenhydramine HCl ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "06d3d2fc-a073-863f-e063-6394a90a2374", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["TC2D6JAD40", "WK2XYI10QM"], "rxcui": ["901814"], "spl_set_id": ["fed2f7ae-2827-f967-e053-6294a90adc0a"], "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": ["VALU MERCHANDISERS COMPANY"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (63941-682-15)  / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE", "package_ndc": "63941-682-15", "marketing_start_date": "20231003"}], "brand_name": "Ibuprofen and Diphenhydramine HCl", "product_id": "63941-682_06d3d2fc-a073-863f-e063-6394a90a2374", "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": "63941-682", "generic_name": "IBUPROFEN, DIPHENHYDRAMINE HCL", "labeler_name": "VALU MERCHANDISERS COMPANY", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Ibuprofen and Diphenhydramine HCl", "active_ingredients": [{"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}, {"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA090397", "marketing_category": "ANDA", "marketing_start_date": "20231003", "listing_expiration_date": "20261231"}