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 53 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Pain Relief Extra Strength ACETAMINOPHEN DISCOUNT DRUG MART e6fee238-0b6f-cb84-e053-2995a90a361b 2024-12-05 Warnings Exact identifier application number: M013 Menstrual Complete Maximum Strength ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE L.N.K. International, Inc. 379ef03c-3b6a-40c3-b736-99f0537d26c8 2024-12-05 Warnings Exact identifier application number: M013 Pain Reliever Extra Strength ACETAMINOPHEN Marc Glassman, Inc. 43bf297f-2832-424f-a013-4bfa1d6c03e6 2024-12-04 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Precision Dose, Inc. 5a68ab98-720c-479a-a60a-4e594add6c09 2024-12-04 Warnings Exact identifier application number: M013 ndc (product): 68094-042 HEB Effervescent Pain Relief ASPIRIN H. E. BUTT GROCERY COMPANY 03876c71-60ec-3280-e063-6294a90a62dc 2024-12-03 Warnings Exact identifier application number: M013 Migrafein FORTE ACETAMINOPHEN, CAFFEINE OPMX LLC 028875c9-4129-ce2c-e063-6294a90a26cc 2024-12-03 Warnings Exact identifier application number: M013 Neo-Lubrina Fuerte ACETAMINOPHEN, CAFFEINE OPMX LLC 0288a327-fd4b-1991-e063-6294a90ace50 2024-12-03 Warnings Exact identifier application number: M013 CAFIZETAMOL FORTE ACETAMINOPHEN, CAFFEINE OPMX LLC 028771d3-a514-f7a5-e063-6394a90ac4f3 2024-12-03 Warnings Exact identifier application number: M013 Buscapina ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE OPMX LLC 048c4b03-1cf4-b724-e063-6294a90a1cad 2024-12-03 Warnings Exact identifier application number: M013 Pain Relief Extra Strength ACETAMINOPHEN TopCo Associates LLC ecd6df7e-e7e2-446b-85ef-25971281fe31 2024-12-03 Warnings Exact identifier application number: M013 Market Basket Effervescent Pain Relief ASPIRIN DEMOULAS SUPER MARKETS, INC. 08133bf0-3c8f-e4d0-e063-6294a90af79a 2024-12-03 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN WinCo Foods, LLC 4359da13-e851-440b-91b9-6b544bff20d2 2024-12-03 Warnings Exact identifier application number: M013 Low Dose Aspirin ASPIRIN WinCo Foods, LLC 5b3e8a78-5357-42ad-811e-b2578b25dc7b 2024-12-03 Warnings Exact identifier application number: M013 Low Strength Chewable Aspirin ASPIRIN Geri-Care Pharmaceutical Corp cc77b9d1-7874-4ce8-a763-3a0e1c2891de 2024-12-03 Warnings Exact identifier application number: M013 Good Sense Childrens Pain and Fever ACETAMINOPHEN L. Perrigo Company c6b79501-d08b-4430-9545-70da5f545975 2024-12-03 Warnings Exact identifier application number: M013 Aspirin ASPIRIN Chain Drug Marketing Association 0e3be5f4-bc1b-4b44-a86a-ace89f6ee592 2024-12-02 Warnings Exact identifier application number: M013 St. Joseph Chewable Low Dose Aspirin ASPIRIN Foundation Consumer Healthcare LLC 248cd302-e380-4837-bdae-9df620b67e8a 2024-12-02 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN AAA Pharmaceutical, Inc. 2d98e390-4f2a-41cc-b307-3d2f6a3700dd 2024-12-02 Warnings Exact identifier application number: M013 Acetaminophen PM ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE AAA Pharmaceutical, Inc. 409b5fcd-5880-4dda-85d8-26aeceb4f8ab 2024-12-02 Warnings Exact identifier application number: M013 Aspirin ASPIRIN AAA Pharmaceutical, Inc. c0c31523-c4c5-43c2-8d72-4d1456c720e9 2024-12-02 Warnings Exact identifier application number: M013
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