safetynadol

Generic: acetaminophen

Labeler: sinew pharma inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name safetynadol
Generic Name acetaminophen
Labeler sinew pharma inc.
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

acetaminophen 500 mg/1

Manufacturer
Sinew Pharma Inc.

Identifiers & Regulatory

Product NDC 81389-001
Product ID 81389-001_08c11030-7b99-55ae-e063-6394a90a1437
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M013
Listing Expiration 2026-12-31
Marketing Start 2021-01-21

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 81389001
Hyphenated Format 81389-001

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 safetynadol (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
  • 200 TABLET, COATED in 1 BOTTLE (81389-001-01)
source: ndc

Packages (1)

81389-001-01 200 TABLET, COATED in 1 BOTTLE (81389-001-01)

Ingredients (1)

acetaminophen (500 mg/1)

Linked Drug Pages (1)

SafeTynadol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "08c11030-7b99-55ae-e063-6394a90a1437", "openfda": {"unii": ["362O9ITL9D"], "rxcui": ["198440"], "spl_set_id": ["b956d527-7ea7-e084-e053-2a95a90a866d"], "manufacturer_name": ["Sinew Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "200 TABLET, COATED in 1 BOTTLE (81389-001-01)", "package_ndc": "81389-001-01", "marketing_start_date": "20210121"}], "brand_name": "SafeTynadol", "product_id": "81389-001_08c11030-7b99-55ae-e063-6394a90a1437", "dosage_form": "TABLET, COATED", "product_ndc": "81389-001", "generic_name": "ACETAMINOPHEN", "labeler_name": "Sinew Pharma Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "SafeTynadol", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "500 mg/1"}], "application_number": "M013", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20210121", "listing_expiration_date": "20261231"}