unisom pm pain nighttime sleep aid and pain reliever

Generic: acetaminophen and diphenhydramine hydrochloride

Labeler: chattem, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name unisom pm pain nighttime sleep aid and pain reliever
Generic Name acetaminophen and diphenhydramine hydrochloride
Labeler chattem, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, diphenhydramine hydrochloride 50 mg/1

Manufacturer
Chattem, Inc.

Identifiers & Regulatory

Product NDC 41167-0040
Product ID 41167-0040_75e0be81-2c6a-461a-9da5-c2aa060e2dc8
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2027-12-31
Marketing Start 2009-12-01

Pharmacologic Class

Classes
histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 411670040
Hyphenated Format 41167-0040

Supplemental Identifiers

RxCUI
1093075 1093077
UNII
362O9ITL9D TC2D6JAD40

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 unisom pm pain nighttime sleep aid and pain reliever (source: ndc)
Generic Name acetaminophen and diphenhydramine hydrochloride (source: ndc)
Application Number M013 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 50 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (41167-0040-2) / 15 TABLET, FILM COATED in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (41167-0040-4) / 30 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (2)

41167-0040-2 1 BOTTLE in 1 CARTON (41167-0040-2) / 15 TABLET, FILM COATED in 1 BOTTLE 41167-0040-4 1 BOTTLE in 1 CARTON (41167-0040-4) / 30 TABLET, FILM COATED in 1 BOTTLE

Ingredients (2)

acetaminophen (325 mg/1) diphenhydramine hydrochloride (50 mg/1)

Linked Drug Pages (1)

Unisom PM Pain Nighttime Sleep Aid and Pain Reliever ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "75e0be81-2c6a-461a-9da5-c2aa060e2dc8", "openfda": {"unii": ["362O9ITL9D", "TC2D6JAD40"], "rxcui": ["1093075", "1093077"], "spl_set_id": ["451daeeb-88a9-44b1-9a2d-1ff0b0ec41cb"], "manufacturer_name": ["Chattem, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (41167-0040-2)  / 15 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "41167-0040-2", "marketing_start_date": "20091201"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (41167-0040-4)  / 30 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "41167-0040-4", "marketing_start_date": "20091201"}], "brand_name": "Unisom PM Pain Nighttime Sleep Aid and Pain Reliever", "product_id": "41167-0040_75e0be81-2c6a-461a-9da5-c2aa060e2dc8", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "41167-0040", "generic_name": "Acetaminophen and Diphenhydramine Hydrochloride", "labeler_name": "Chattem, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Unisom PM Pain Nighttime Sleep Aid and Pain Reliever", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "M013", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20091201", "listing_expiration_date": "20271231"}