Home NDC 35916-0183-3 Acetaminophen
Product NDC 35916-0183
Requested package NDC 35916-0183-3
11-digit product format 359160183
Labeler code 35916
Product ID 35916-0183_57593d02-16fb-2611-e063-6294a90ad030
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Softgel Healthcare Pvt Ltd
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-05-17
Substance ACETAMINOPHEN
Active strength 500 mg/1
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 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 198439 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 35916-0183-2 Acetaminophen 3000 in 1 POUCH CAPSULE, LIQUID FILLED 3000 6 35916-0183-3 Acetaminophen 2000 in 1 POUCH CAPSULE, LIQUID FILLED 2000 6 35916-0183-3 Acetaminophen 2 in 1 BOX CAPSULE, LIQUID FILLED 2 6 35916-0183-4 Acetaminophen 2 in 1 BOX CAPSULE, LIQUID FILLED 2 6 35916-0183-4 Acetaminophen 1500 in 1 BAG CAPSULE, LIQUID FILLED 1500 6
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 Units Marketing start Sample Exclude flag Status 35916-0183-3 35916018303 2 POUCH in 1 BOX (35916-0183-3) / 2000 CAPSULE, LIQUID FILLED in 1 POUCH 2 pouch 2025-09-24 No No Current