Acetaminophen

Product NDC: 52343-555
11-digit product format: 523430555
Labeler code: 52343
Product ID: 52343-555_68776ec5-dc83-4edb-b117-3326c2d999aa
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: SOLUTION
Route: ORAL
Labeler: Acetris Pharma Holdings, LLC
Application: M013.50
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2026-05-13
Substance: ACETAMINOPHEN
Active strength: 160 mg/5mL
NDC exclude flag: No
Listing certified through: 2027-12-31
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: 2027-12-31

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
dacbe2eb-f412-4629-a8ff-237c7fd10ab6	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52343-555-12	Acetaminophen	118 mL in 1 BOTTLE, PLASTIC	SOLUTION	118		1

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetaminophen	ACETAMINOPHEN	Acetris Pharma Holdings, LLC	dacbe2eb-f412-4629-a8ff-237c7fd10ab6	2026-05-13	Warnings	Exact identifier ndc (product): 52343-555

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	dacbe2eb-f412-4629-a8ff-237c7fd10ab6	1
307675	acetaminophen 32 MG/ML Oral Solution	SCD	dacbe2eb-f412-4629-a8ff-237c7fd10ab6	1
307675	acetaminophen 160 MG per 5 ML Oral Solution	SY	dacbe2eb-f412-4629-a8ff-237c7fd10ab6	1
307675	acetaminophen 325 MG per 10.15 ML Oral Solution	SY	dacbe2eb-f412-4629-a8ff-237c7fd10ab6	1
307675	acetaminophen 650 MG per 20.3 ML Oral Solution	SY	dacbe2eb-f412-4629-a8ff-237c7fd10ab6	1
307675	acetaminophen 80 MG per 2.5 ML Oral Solution	SY	dacbe2eb-f412-4629-a8ff-237c7fd10ab6	1
307675	APAP 32 MG/ML Oral Solution	SY	dacbe2eb-f412-4629-a8ff-237c7fd10ab6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
52343-555-12	52343055512	118 mL in 1 BOTTLE, PLASTIC (52343-555-12)	118 ml	2026-05-13	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acetaminophen Oral Solution USP, 160 mg/5 mL	Acetris Pharma Holdings, LLC \| Invahealth Inc.	2026-05-13	HUMAN OTC DRUG LABEL	1