Home NDC 63868-809 Acetaminophen
Product NDC 63868-809
11-digit product format 638680809
Labeler code 63868
Product ID 63868-809_14e59795-60fb-4d85-baf8-176539f86505
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form SYRUP
Route ORAL
Labeler CHAIN DRUG MARKETING ASSOCIATION INC.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-07-01
Substance ACETAMINOPHEN
Active strength 500 mg/15mL
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 Acetaminophen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/15mL
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 307684 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 63868-809-08 Acetaminophen 237 mL in 1 BOTTLE SYRUP 237 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63868-809 ACETAMINOPHEN SYRUP [CHAIN DRUG MARKETING ASSOCIATION INC.] 2 Current NDC, 1 package rows 20241228_1608b4f0-bf20-4024-b8f2-20a4df7a4b21.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 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 Sample Exclude flag Status 63868-809-08 63868080908 237 mL in 1 BOTTLE (63868-809-08) 237 ml 2023-07-01 No No Current