Home NDC 81389-001-01 SafeTynadol
Product NDC 81389-001
Requested package NDC 81389-001-01
11-digit product format 813890001
Labeler code 81389
Product ID 81389-001_08c11030-7b99-55ae-e063-6394a90a1437
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN
Dosage form TABLET, COATED
Route ORAL
Labeler Sinew Pharma Inc.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-01-21
Substance ACETAMINOPHEN
Active strength 500 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base SafeTynadol
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198440 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 81389-001-01 SafeTynadol 200 in 1 BOTTLE TABLET, COATED 200 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81389-001 SAFETYNADOL (ACETAMINOPHEN) TABLET, COATED [SINEW PHARMA INC.] 3 Current NDC, Legacy NDC, 1 package rows 20231030_b956d527-7ea7-e084-e053-2a95a90a866d.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 83 · 1,657 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 81389-001-01 81389000101 200 TABLET, COATED in 1 BOTTLE (81389-001-01) 2021-01-21 0000-00-00 No No Current