Home NDC 69729-028 Acetaminophen
Product NDC 69729-028
11-digit product format 697290028
Labeler code 69729
Product ID 69729-028_5c3f9409-c92e-78dd-e063-6294a90aa7d4
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form SUSPENSION
Route ORAL
Labeler OPMX LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-02-01
Substance ACETAMINOPHEN
Active strength 160 mg/5mL
NDC exclude flag No
Listing certified through 2027-12-31
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 Acetaminophen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 160 mg/5mL
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69729-028-02 Acetaminophen 60 mL in 1 BOTTLE SUSPENSION 60 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69729-028 ACETAMINOPHEN SUSPENSION TEMP X (ACETAMINOPHEN) SUSPENSION MEJORALITO (ACETAMINOPHEN) SUSPENSION [OPMX LLC] 5 Current NDC, Legacy NDC, 1 package rows 20230609_5b8a92c9-47c0-4438-a49d-b3878f7afd73.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 59 of 79 · 1,579 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69729-028-02 69729002802 60 mL in 1 BOTTLE (69729-028-02) 60 ml 2021-02-01 0000-00-00 No No Current