extra strength acetaminophen pm

Generic: acetaminophen 500mg/ diphenhydramine hcl 25mg

Labeler: time cap labs inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name extra strength acetaminophen pm
Generic Name acetaminophen 500mg/ diphenhydramine hcl 25mg
Labeler time cap labs inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

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

Manufacturer
TIME CAP LABS INC

Identifiers & Regulatory

Product NDC 49483-430
Product ID 49483-430_3a6f8b16-c8a2-7195-e063-6394a90ac5fd
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2026-12-31
Marketing Start 2023-07-22

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 49483430
Hyphenated Format 49483-430

Supplemental Identifiers

RxCUI
1092189
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 extra strength acetaminophen pm (source: ndc)
Generic Name acetaminophen 500mg/ diphenhydramine hcl 25mg (source: ndc)
Application Number M013 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
  • 25 mg/1
source: ndc
Packaging
  • 400 TABLET in 1 BOTTLE (49483-430-40)
source: ndc

Packages (1)

49483-430-40 400 TABLET in 1 BOTTLE (49483-430-40)

Ingredients (2)

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

Linked Drug Pages (1)

Extra strength Acetaminophen PM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3a6f8b16-c8a2-7195-e063-6394a90ac5fd", "openfda": {"unii": ["362O9ITL9D", "TC2D6JAD40"], "rxcui": ["1092189"], "spl_set_id": ["010c5c98-fc67-a9c3-e063-6394a90aa640"], "manufacturer_name": ["TIME CAP LABS INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "400 TABLET in 1 BOTTLE (49483-430-40)", "package_ndc": "49483-430-40", "marketing_start_date": "20230722"}], "brand_name": "Extra strength Acetaminophen PM", "product_id": "49483-430_3a6f8b16-c8a2-7195-e063-6394a90ac5fd", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "49483-430", "generic_name": "Acetaminophen 500mg/ Diphenhydramine HCl 25mg", "labeler_name": "TIME CAP LABS INC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Extra strength Acetaminophen 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": "20230722", "listing_expiration_date": "20261231"}