Home NDC 68094-042 Acetaminophen
Product NDC 68094-042
11-digit product format 680940042
Labeler code 68094
Product ID 68094-042_58724859-e9d7-4352-9797-62e2f98b851b
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form SUSPENSION
Route ORAL
Labeler Precision Dose, Inc.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-01-13
Substance ACETAMINOPHEN
Active strength 160 mg/5mL
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 160 mg/5mL
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 307668 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 68094-042-01 Acetaminophen 2.5 mL in 1 SYRINGE, PLASTIC SUSPENSION 2.5 1 68094-042-58 Acetaminophen 10 in 1 BAG SUSPENSION 10 1 68094-042-58 Acetaminophen 5 in 1 CASE SUSPENSION 5 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68094-042 ACETAMINOPHEN SUSPENSION [PRECISION DOSE, INC.] 1 Current NDC, 3 package rows 20250113_5a68ab98-720c-479a-a60a-4e594add6c09.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 64 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 68094-042-01 68094004201 2.5 mL in 1 SYRINGE, PLASTIC 2.5 ml Historical 68094-042-58 68094004258 5 BAG in 1 CASE (68094-042-58) / 10 SYRINGE, PLASTIC in 1 BAG / 2.5 mL in 1 SYRINGE, PLASTIC (68094-042-01) 5 bag 2025-01-13 No No Current