acetaminophen

Generic: acetaminophen

Labeler: sam's west inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name acetaminophen
Generic Name acetaminophen
Labeler sam's west inc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

acetaminophen 500 mg/1

Manufacturer
Sam's West Inc

Identifiers & Regulatory

Product NDC 68196-031
Product ID 68196-031_a7c1270c-69f4-4fff-a37d-aaa6b5eb7cb8
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2026-12-31
Marketing Start 2025-11-14

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68196031
Hyphenated Format 68196-031

Supplemental Identifiers

RxCUI
198440
UNII
362O9ITL9D

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 acetaminophen (source: ndc)
Generic Name acetaminophen (source: ndc)
Application Number M013 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 600 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68196-031-06)
source: ndc

Packages (1)

68196-031-06 600 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68196-031-06)

Ingredients (1)

acetaminophen (500 mg/1)

Linked Drug Pages (1)

Acetaminophen ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a7c1270c-69f4-4fff-a37d-aaa6b5eb7cb8", "openfda": {"unii": ["362O9ITL9D"], "rxcui": ["198440"], "spl_set_id": ["1098d0e7-8202-4018-a2d2-b0c80ee58b56"], "manufacturer_name": ["Sam's West Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "600 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68196-031-06)", "package_ndc": "68196-031-06", "marketing_start_date": "20251114"}], "brand_name": "Acetaminophen", "product_id": "68196-031_a7c1270c-69f4-4fff-a37d-aaa6b5eb7cb8", "dosage_form": "TABLET, FILM COATED", "product_ndc": "68196-031", "generic_name": "Acetaminophen", "labeler_name": "Sam's West Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Acetaminophen", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "500 mg/1"}], "application_number": "M013", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20251114", "listing_expiration_date": "20261231"}