care one ibuprofen pm

Generic: diphenhydramine citrate and ibuprofen

Labeler: american sales company
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name care one ibuprofen pm
Generic Name diphenhydramine citrate and ibuprofen
Labeler american sales company
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

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

Manufacturer
American Sales Company

Identifiers & Regulatory

Product NDC 41520-050
Product ID 41520-050_d9f3e753-6ae4-485b-ad78-6e39bd46f445
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA079113
Listing Expiration 2026-12-31
Marketing Start 2009-02-20

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 41520050
Hyphenated Format 41520-050

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 care one ibuprofen pm (source: ndc)
Generic Name diphenhydramine citrate and ibuprofen (source: ndc)
Application Number ANDA079113 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 38 mg/1
  • 200 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (41520-050-27) / 80 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (41520-050-58) / 40 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (41520-050-60) / 20 TABLET, FILM COATED in 1 BOTTLE
  • 200 TABLET, FILM COATED in 1 BOTTLE (41520-050-82)
source: ndc

Packages (4)

41520-050-27 1 BOTTLE in 1 CARTON (41520-050-27) / 80 TABLET, FILM COATED in 1 BOTTLE 41520-050-58 1 BOTTLE in 1 CARTON (41520-050-58) / 40 TABLET, FILM COATED in 1 BOTTLE 41520-050-60 1 BOTTLE in 1 CARTON (41520-050-60) / 20 TABLET, FILM COATED in 1 BOTTLE 41520-050-82 200 TABLET, FILM COATED in 1 BOTTLE (41520-050-82)

Ingredients (2)

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

Linked Drug Pages (1)

Care One Ibuprofen PM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d9f3e753-6ae4-485b-ad78-6e39bd46f445", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722"], "unii": ["4OD433S209", "WK2XYI10QM"], "rxcui": ["895664"], "spl_set_id": ["d5bf76d1-6fed-4f6b-8507-3e8973295d67"], "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": ["American Sales Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (41520-050-27)  / 80 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "41520-050-27", "marketing_start_date": "20090220"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (41520-050-58)  / 40 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "41520-050-58", "marketing_start_date": "20090220"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (41520-050-60)  / 20 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "41520-050-60", "marketing_start_date": "20090220"}, {"sample": false, "description": "200 TABLET, FILM COATED in 1 BOTTLE (41520-050-82)", "package_ndc": "41520-050-82", "marketing_start_date": "20170905"}], "brand_name": "Care One Ibuprofen PM", "product_id": "41520-050_d9f3e753-6ae4-485b-ad78-6e39bd46f445", "dosage_form": "TABLET, FILM 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": "41520-050", "generic_name": "diphenhydramine citrate and ibuprofen", "labeler_name": "American Sales Company", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Care One Ibuprofen PM", "active_ingredients": [{"name": "DIPHENHYDRAMINE CITRATE", "strength": "38 mg/1"}, {"name": "IBUPROFEN", "strength": "200 mg/1"}], "application_number": "ANDA079113", "marketing_category": "ANDA", "marketing_start_date": "20090220", "listing_expiration_date": "20261231"}