tylenol pm

Generic: acetaminophen, guaifenesin, phenylephrine hydrochloride

Labeler: jc world bell wholesale co., inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name tylenol pm
Generic Name acetaminophen, guaifenesin, phenylephrine hydrochloride
Labeler jc world bell wholesale co., inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

acetaminophen 500 mg/1, diphenhydramine hydrochloride 25 mg/1

Manufacturer
JC World Bell Wholesale Co., Inc.

Identifiers & Regulatory

Product NDC 50269-552
Product ID 50269-552_47bb04a2-2d89-ea44-e063-6294a90a1986
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2027-12-31
Marketing Start 2016-07-11

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 50269552
Hyphenated Format 50269-552

Supplemental Identifiers

RxCUI
1092189 1092378
UNII
362O9ITL9D TC2D6JAD40

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 tylenol pm (source: ndc)
Generic Name acetaminophen, guaifenesin, phenylephrine hydrochloride (source: ndc)
Application Number M013 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
  • 25 mg/1
source: ndc
Packaging
  • 20 POUCH in 1 BOX (50269-552-01) / 2 TABLET, FILM COATED in 1 POUCH
source: ndc

Packages (1)

50269-552-01 20 POUCH in 1 BOX (50269-552-01) / 2 TABLET, FILM COATED in 1 POUCH

Ingredients (2)

acetaminophen (500 mg/1) diphenhydramine hydrochloride (25 mg/1)

Linked Drug Pages (1)

Tylenol PM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47bb04a2-2d89-ea44-e063-6294a90a1986", "openfda": {"unii": ["362O9ITL9D", "TC2D6JAD40"], "rxcui": ["1092189", "1092378"], "spl_set_id": ["938c43f9-c8dd-48c1-a954-6e2c5f56562f"], "manufacturer_name": ["JC World Bell Wholesale Co., Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "20 POUCH in 1 BOX (50269-552-01)  / 2 TABLET, FILM COATED in 1 POUCH", "package_ndc": "50269-552-01", "marketing_start_date": "20160711"}], "brand_name": "Tylenol PM", "product_id": "50269-552_47bb04a2-2d89-ea44-e063-6294a90a1986", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "50269-552", "generic_name": "ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE", "labeler_name": "JC World Bell Wholesale Co., Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Tylenol PM", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "500 mg/1"}, {"name": "DIPHENHYDRAMINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "M013", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20160711", "listing_expiration_date": "20271231"}