Liquid Acetaminophen

Product NDC: 54859-809
11-digit product format: 548590809
Labeler code: 54859
Product ID: 54859-809_47461076-1bb2-ffd6-e063-6294a90a5885
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: LIQUID
Route: ORAL
Labeler: LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-10-01
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: Liquid 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
307675	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a7dbd4c0-53eb-4368-917b-1432c09ce6b4	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54859-809-16	Liquid Acetaminophen	473 mL in 1 BOTTLE	LIQUID	473		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54859-809-16	ML - Milliliter	54859-809	a7cc10e7-86b4-485c-901e-bc571c0f4d11	1	2020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54859-809	LIQUID ACETAMINOPHEN (ACETAMINOPHEN) LIQUID [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]	4	Current NDC, Legacy NDC, 1 package rows	20241222_a7dbd4c0-53eb-4368-917b-1432c09ce6b4.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 25 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Excedrin Extra Strength Headache	ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE	Select Consumer Group	3caa0a47-de83-90d2-e063-6394a90a3436	2025-12-27	Warnings	Exact identifier application number: M013
Aspirin Pain reliver	ASPIRIN	Pioneer Life Sciences, LLC	c2759844-a49c-450f-e053-2a95a90a2972	2025-12-26	Warnings	Exact identifier application number: M013
Menstrual Complete	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	Pioneer Life Sciences, LLC	aa2de3a5-a20d-33c6-e053-2a95a90ada3e	2025-12-26	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	Discount Drug Mart	2aa0f9f3-924c-4a4a-bb5f-2a326acc2408	2025-12-26	Warnings	Exact identifier application number: M013
GenCare Headache Relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Pioneer Life Sciences, LLC	667f6f1b-5179-481c-a131-940c7937aada	2025-12-26	Warnings	Exact identifier application number: M013
Pharbetol	ACETAMINOPHEN	Pharbest Pharmaceuticals, Inc.	04dbd98f-c74d-43b2-8bda-74f18be7cf6c	2025-12-24	Warnings	Exact identifier application number: M013
Adult Low Dose Aspirin Enteric Coated	ASPIRIN 81MG	Pharbest Pharmaceuticals, Inc.	45e5bae9-22a7-4699-85ea-5b922af6b96d	2025-12-24	Warnings	Exact identifier application number: M013
Aspirin 325 mg	ASPIRIN	BETTER LIVING BRANDS, LLC	424a242f-c8c6-9dd7-e063-6394a90ab4d5	2025-12-24	Warnings	Exact identifier application number: M013
Low Dose Aspirin	ASPIRIN	Pharbest Pharmaceuticals, Inc.	2763a733-d617-4d95-8429-fbf81d9d77fb	2025-12-24	Warnings	Exact identifier application number: M013
Pharbetol Regular strength	ACETAMINOPHEN	Pharbest Pharmaceuticals, Inc.	e0a39957-d918-4125-88f9-0e550b976fa1	2025-12-24	Warnings	Exact identifier application number: M013
PHARBETOL	ACETAMINOPHEN 500MG	Pharbest Pharmaceuticals, Inc.	27337be9-e279-460e-903e-ae4463099599	2025-12-24	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	PUBLIX SUPERMARKETS, INC	08f5af1d-365b-a97c-e063-6394a90a99ae	2025-12-23	Warnings	Exact identifier application number: M013
ACETAMINOPHEN 500 MG	ACETAMINOPHEN	Pioneer Life Sciences, LLC	0d67bb52-7ae3-439e-9e47-4e21eb0ca352	2025-12-23	Warnings	Exact identifier application number: M013
ACETAMINOPHEN 500 MG	ACETAMINOPHEN	Pioneer Life Sciences, LLC	11e6ec2a-5171-4496-a15f-6ff744bd1f2f	2025-12-23	Warnings	Exact identifier application number: M013
Aspirin Pain reliver	ASPIRIN	Pioneer Life Sciences, LLC	8dc29957-2ac1-47f8-89fd-a6bcf97ee3d3	2025-12-23	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Granules USA, Inc	a1255f60-b9c6-9a95-e053-2995a90a9e80	2025-12-22	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Granules USA, Inc	a51395ea-e038-dc9c-e053-2a95a90a287d	2025-12-22	Warnings	Exact identifier application number: M013
CareALL Acetaminophen	ACETAMINOPHEN	New World Imports, Inc	1148b4d9-fa6a-49e6-9663-17b2c8373846	2025-12-22	Warnings	Exact identifier application number: M013
CAREALL Aspirin	ASPIRIN	New World Imports, Inc	f4aa0de9-ffcc-4140-91a3-fd9e7a55f2ac	2025-12-22	Warnings	Exact identifier application number: M013
Vitapirena	ACETAMINOPHEN	Pharmadel LLC	0547bc1f-d000-f5a6-e063-6294a90ac73d	2025-12-22	Warnings	Exact identifier application number: M013

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
307675	acetaminophen 160 MG in 5 mL Oral Solution	PSN	a7dbd4c0-53eb-4368-917b-1432c09ce6b4	6
307675	acetaminophen 32 MG/ML Oral Solution	SCD	a7dbd4c0-53eb-4368-917b-1432c09ce6b4	6
307675	acetaminophen 160 MG per 5 ML Oral Solution	SY	a7dbd4c0-53eb-4368-917b-1432c09ce6b4	6
307675	acetaminophen 325 MG per 10.15 ML Oral Solution	SY	a7dbd4c0-53eb-4368-917b-1432c09ce6b4	6
307675	acetaminophen 650 MG per 20.3 ML Oral Solution	SY	a7dbd4c0-53eb-4368-917b-1432c09ce6b4	6
307675	acetaminophen 80 MG per 2.5 ML Oral Solution	SY	a7dbd4c0-53eb-4368-917b-1432c09ce6b4	6
307675	APAP 32 MG/ML Oral Solution	SY	a7dbd4c0-53eb-4368-917b-1432c09ce6b4	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54859-809-16	54859080916	473 mL in 1 BOTTLE (54859-809-16)	473 ml	2019-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Llorens- Liquid Acetaminophen 809	LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION	2025-12-31	HUMAN OTC DRUG LABEL	6
Acetaminophen Oral Liquid Unit Dose Oral ENFit® Syringe (160 mg / 5 mL)	Safecor Health, LLC	2022-12-28	HUMAN OTC DRUG LABEL	1