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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5a68ab98-720c-479a-a60a-4e594add6c09	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68094-042-01	ML - Milliliter	68094-042	7ec21617-9121-4b43-b3d5-d0fee46ed4ea	1	2025-03-04
68094-042-58	ML - Milliliter	68094-042	bc1fd5c0-9342-47e5-9e24-a2f46f04d77b	1	2025-03-04

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 4 of 83 · 1,657 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
pain relief childrens	ACETAMINOPHEN	Rite Aid Corporation	29ecdd2d-aeaf-40a8-a347-011088009ea6	2026-08-11	Warnings	Exact identifier application number: M013
Fast Acting Pedia Crae	ACETAMINOPHEN	Randob Labs., Ltd.	e069060f-fbb2-4c7a-b872-00b3ab86d01b	2026-08-11	Warnings	Exact identifier application number: M013
ASPIRIN	ASPIRIN	Amazon.com Services LLC	c7cc0681-4c0b-4565-99df-d0168c8ba1ba	2026-08-10	Warnings	Exact identifier application number: M013
GenCare Headache Relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Pioneer Life Sciences, LLC	ac8c4bdf-30c9-2b09-e053-2a95a90a9b67	2026-08-09	Warnings	Exact identifier application number: M013
Gencare-Aspirin Low Dose Pain reliever (NSAID)	ASPIRIN	Pioneer Life Sciences, LLC	24d4f46a-c7a5-4e94-804f-1e307d8e8cfc	2026-08-09	Warnings	Exact identifier application number: M013
Aspirin 81 mg	ASPIRIN	DOLGENCORP, LLC	b4064039-2345-4227-b83d-54dc13a838d3	2026-08-07	Warnings	Exact identifier application number: M013
Aspirin Low Dose	ASPIRIN	United Natural Foods, Inc. dba UNFI	87def9e0-0246-42cf-b8ea-2513d52e9f68	2026-08-07	Warnings	Exact identifier application number: M013
berkley and jensen acetaminophen	ACETAMINOPHEN	BJWC	dee57d73-73ac-48bb-b1da-9971f1ff21c4	2026-08-07	Warnings	Exact identifier application number: M013
Pain Reliever PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Salado Sales, Inc.	aef30709-f33d-48ff-b2d4-0639ffbd1ffd	2026-08-07	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	P & L Development, LLC	4cd74cec-a209-4e92-b853-fbe5c95f7678	2026-08-06	Warnings	Exact identifier application number: M013
Tension Headache Aspirin-Free	ACETAMINOPHEN, CAFFEINE	Rite Aid Corporation	093a7c26-f2b1-4416-b193-81133d247d2e	2026-08-06	Warnings	Exact identifier application number: M013
ACETAMINOPHEN	ACETAMINOPHEN	Kroger Company	bc17b2e5-4828-6a2e-e053-2995a90a8c63	2026-08-05	Warnings	Exact identifier application number: M013
Infants TYLENOL	ACETAMINOPHEN	Kenvue Brands LLC	997b9551-c222-4a9c-8ba1-09a5f97495fa	2026-08-05	Warnings	Exact identifier application number: M013
Mantra Pain Gel raspberry	ACETAMINOPHEN	MOREMED INC.	7c8bdf49-a6d2-4e42-b006-375f103fd0ac	2026-08-05	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	HARRIS TEETER	d2d2846d-4e0b-4d42-b300-60dd3b2cca1b	2026-08-05	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	HARRIS TEETER	960f5676-d8c5-470b-a663-4b8d152339b4	2026-08-05	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	HARRIS TEETER	a60f6439-2033-4bd2-b78c-6c083414a12b	2026-08-05	Warnings	Exact identifier application number: M013
pain relief PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	HARRIS TEETER	0afb6181-d0b1-4845-8230-faabf1b997dc	2026-08-05	Warnings	Exact identifier application number: M013
Acetaminophen PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	Harris Teeter	8a3e3439-90ae-4fc9-8ff2-44b8363fa338	2026-08-05	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Harris Teeter	50e7b939-e0eb-44ea-82ea-034e844e2c29	2026-08-05	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
307668	acetaminophen 160 MG in 5 mL Oral Suspension	PSN	5a68ab98-720c-479a-a60a-4e594add6c09	1
307668	acetaminophen 32 MG/ML Oral Suspension	SCD	5a68ab98-720c-479a-a60a-4e594add6c09	1
307668	acetaminophen 160 MG per 5 ML Oral Suspension	SY	5a68ab98-720c-479a-a60a-4e594add6c09	1
307668	acetaminophen 320 MG per 10 ML Oral Suspension	SY	5a68ab98-720c-479a-a60a-4e594add6c09	1
307668	acetaminophen 650 MG per 20.3 ML Oral Suspension	SY	5a68ab98-720c-479a-a60a-4e594add6c09	1
307668	acetaminophen 80 MG per 2.5 ML Oral Suspension	SY	5a68ab98-720c-479a-a60a-4e594add6c09	1
307668	APAP 32 MG/ML Oral Suspension	SY	5a68ab98-720c-479a-a60a-4e594add6c09	1

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