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 31 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pain Reliever PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Walgreen Company	b4d8860b-d72f-4789-945e-1c6420a8efab	2025-12-02	Warnings	Exact identifier application number: M013
Infants Pain and Fever	ACETAMINOPHEN	WALGREEN COMPANY	f7b304d8-e37c-4ac6-b4a2-1797b92cb832	2025-12-01	Warnings	Exact identifier application number: M013
Dye FreeInfants Pain and Fever	ACETAMINOPHEN	WALGREEN COMPANY	1a304570-88b6-4c16-a8b4-c064bfa5d95a	2025-12-01	Warnings	Exact identifier application number: M013
Walgreen Severe Multi-Symptom Cough Cold Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	WALGREENS	b48d93fe-bb60-493f-8d1a-b2dc864203c4	2025-12-01	Warnings	Exact identifier application number: M013
Multi Symptom Severe Cold and Nighttime Severe Cold and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	WALGREEN CO.	6c4ab613-a587-4ec4-9986-f1d000bc2d23	2025-12-01	Warnings	Exact identifier application number: M013
WAG HBP Daytime and Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	WALGREENS CO.	ac2f9ce8-e402-4451-a412-e99248a6ecbe	2025-12-01	Warnings	Exact identifier application number: M013
Walgreen Day Time NightTime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE,GUAIFENESIN	WALGREENS CO.	5505217a-9679-4668-bdab-5d4553a47c56	2025-12-01	Warnings	Exact identifier application number: M013
CAREALL Aspirin	ASPIRIN	New World Imports, Inc	58a371d4-1f00-4fda-8e08-80610c58505a	2025-12-01	Warnings	Exact identifier application number: M013
CareALL Non Aspirin Extra Strength	ACETAMINOPHEN	New World Imports, Inc	da05a1a1-35b4-4787-8c56-12e369f18ff0	2025-12-01	Warnings	Exact identifier application number: M013
CareALL Acetaminophen Extra Strength	ACETAMINOPHEN	New World Imports, Inc	80a699b9-bf5c-4765-9e20-ccbc7e3ace7a	2025-12-01	Warnings	Exact identifier application number: M013
CareALL Acetaminophen Extra Strength	ACETAMINOPHEN	New World Imports, Inc	66244cdb-2680-4fa8-890d-32aefd490038	2025-12-01	Warnings	Exact identifier application number: M013
Family Wellness Childrens Pain Reliever 574	ACETAMINOPHEN	Family Dollar Services, Inc.	902c1136-04d2-41f0-81c6-412663cdf378	2025-12-01	Warnings	Exact identifier application number: M013
WalgreenChildrens Pain Fever	ACETAMINOPHEN	WALGREENS CO.	2f757cde-2604-4ca4-b54e-e444f3757cdd	2025-11-26	Warnings	Exact identifier application number: M013
Walgreen Childrens Pain plus Fever	ACETAMINOPHEN	WALGREENS CO.	29ca2855-3c07-435d-a8e1-2997fcedd088	2025-11-26	Warnings	Exact identifier application number: M013
Walgreens Childrens Cold plus Cough plus Runny Nose	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE	WALGREENS CO.	8714d4e6-3a3b-48c8-8ac1-51b933a2ceac	2025-11-26	Warnings	Exact identifier application number: M013
Pain Reliever, 24/7 Life by 7-Eleven	ACETAMINOPHEN TABLET, FILM COATED	Lil' Drug Store Products, Inc.	44828b89-2563-b233-e063-6294a90ab124	2025-11-26	Warnings	Exact identifier application number: M013
MEMBERS MARK ACETAMINOPHEN	ACETAMINOPHEN	Sam's West Inc	03e831d4-8060-4633-9d02-e77100063fb4	2025-11-26	Warnings	Exact identifier application number: M013
Childrens Pain and Fever Dissolve Packs	ACETAMINOPHEN	WALGREENS CO.	ea0f265f-7d64-4731-beda-0bb841dd1ad7	2025-11-25	Warnings	Exact identifier application number: M013
Sore Throat Logenzes Sore Throat	BENZOCAINE AND MENTHOL	ATLANTIC BIOLOGICALS CORP.	71a80e13-bda3-40fb-b4e7-45e9985e707c	2025-11-24	Warnings	Exact identifier application number: M013
better living brands childrens fever and pain reliver	ACETAMINOPHEN	BETTER LIVING BRANDS LLC	c13ced61-c491-4fc2-b83f-78c6d9ad8546	2025-11-20	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