Childrens Acetaminophen

Product NDC: 68094-587
11-digit product format: 680940587
Labeler code: 68094
Product ID: 68094-587_e6ac04f4-d5e9-4945-9a8c-6db8add7570a
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: SUSPENSION
Route: ORAL
Labeler: Precision Dose Inc.
Application: part343
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2014-04-11
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN
Active strength: 160 mg/5mL
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68094-587		D	Discontinued by firm	2026-10-15
excluded package	package	68094-587	68094-587-58	D	Discontinued by firm	2026-10-15
excluded package	package	68094-587	68094-587-61	D	Discontinued by firm	2026-10-15
excluded package	package	68094-587	68094-587-62	D	Discontinued by firm	2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68094-587-61	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68094-587-62	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68094-587-58	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68094-587-61	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68094-587-62	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68094-587-58	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68094-587-61	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68094-587-62	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68094-587-58	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68094-587-61	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68094-587-62	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68094-587-58	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68094-587-61	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68094-587-62	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68094-587-58	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68094-587-61	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68094-587-62	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68094-587-58	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68094-587-61	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68094-587-62	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68094-587-58	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68094-587-61	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68094-587-62	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68094-587-58	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68094-587-61	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68094-587-62	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68094-587-58	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68094-587-61	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68094-587-62	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68094-587-58	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68094-587-61	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68094-587-62	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68094-587-58	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68094-587-61	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68094-587-62	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68094-587-58	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68094-587-58	ML - Milliliter	68094-587	14529737-7c59-46b4-8359-299a85dd4961	1	2014-06-03
68094-587-59	ML - Milliliter	68094-587	99afddc2-b1ef-479d-8165-05285174dd2a	1	2014-06-03
68094-587-61	ML - Milliliter	68094-587	e15c6260-04f1-4480-8f82-b7e08cfd98f4	1	2014-06-03
68094-587-62	ML - Milliliter	68094-587	917251eb-e7b2-485c-b293-37cb83622675	1	2014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Acetaminophen	ACTIVE INGREDIENT	362O9ITL9D	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [CARDINAL HEALTH]	1
Acetaminophen	ACTIVE INGREDIENT	362O9ITL9D	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]	1
Acetaminophen	ACTIVE MOIETY	362O9ITL9D	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]	1
Acetaminophen	ACTIVE MOIETY	362O9ITL9D	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [CARDINAL HEALTH]	1
anhydrous citric acid	INACTIVE INGREDIENT	XF417D3PSL	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]	1
anhydrous citric acid	INACTIVE INGREDIENT	XF417D3PSL	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [CARDINAL HEALTH]	1
butylparaben	INACTIVE INGREDIENT	3QPI1U3FV8	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]	1
butylparaben	INACTIVE INGREDIENT	3QPI1U3FV8	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [CARDINAL HEALTH]	1
calcium sulfate	INACTIVE INGREDIENT	WAT0DDB505	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]	1
calcium sulfate	INACTIVE INGREDIENT	WAT0DDB505	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [CARDINAL HEALTH]	1
carboxymethylcellulose sodium	INACTIVE INGREDIENT	K679OBS311	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [CARDINAL HEALTH]	1
carboxymethylcellulose sodium	INACTIVE INGREDIENT	K679OBS311	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]	1
carrageenan	INACTIVE INGREDIENT	5C69YCD2YJ	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]	1
carrageenan	INACTIVE INGREDIENT	5C69YCD2YJ	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [CARDINAL HEALTH]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [CARDINAL HEALTH]	1
D&C red no. 33	INACTIVE INGREDIENT	9DBA0SBB0L	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]	1
D&C red no. 33	INACTIVE INGREDIENT	9DBA0SBB0L	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [CARDINAL HEALTH]	1
FD&C blue no. 1	INACTIVE INGREDIENT	H3R47K3TBD	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]	1
FD&C blue no. 1	INACTIVE INGREDIENT	H3R47K3TBD	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [CARDINAL HEALTH]	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [CARDINAL HEALTH]	1
high fructose corn syrup	INACTIVE INGREDIENT	XY6UN3QB6S	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]	1
high fructose corn syrup	INACTIVE INGREDIENT	XY6UN3QB6S	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [CARDINAL HEALTH]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [CARDINAL HEALTH]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]	1
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [CARDINAL HEALTH]	1
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]	1
sodium phosphate, tribasic	INACTIVE INGREDIENT	A752Q30A6X	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]	1
sodium phosphate, tribasic	INACTIVE INGREDIENT	A752Q30A6X	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [CARDINAL HEALTH]	1
sorbitol	INACTIVE INGREDIENT	506T60A25R	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]	1
sorbitol	INACTIVE INGREDIENT	506T60A25R	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [CARDINAL HEALTH]	1
water	INACTIVE INGREDIENT	059QF0KO0R	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [CARDINAL HEALTH]	1

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68094-587-58	68094058758	5 BAG in 1 CASE (68094-587-58) > 10 SYRINGE, PLASTIC in 1 BAG > 5 mL in 1 SYRINGE, PLASTIC	5 bag	2014-04-11	0000-00-00	No	No	Current
68094-587-61	68094058761	10 TRAY in 1 CASE (68094-587-61) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (68094-587-59)	10 tray	2014-04-11	0000-00-00	No	No	Current
68094-587-62	68094058762	3 TRAY in 1 CASE (68094-587-62) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (68094-587-59)	3 tray	2014-04-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CHILDREN'S ACETAMINOPHEN ORAL SUSPENSION	Precision Dose Inc.	2022-09-12	HUMAN OTC DRUG LABEL	4
CHILDREN'S ACETAMINOPHEN ORAL SUSPENSION	Cardinal Health	2020-05-20	HUMAN OTC DRUG LABEL	5