Childrens Acetaminophen

Product NDC: 68094-588
Requested package NDC: 68094-588-62
11-digit product format: 680940588
Labeler code: 68094
Product ID: 68094-588_c17a8b17-f717-48c9-960b-aa1e2f87de4d
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: 2014-04-23
Marketing end: 2021-03-31
Substance: ACETAMINOPHEN
Active strength: 160 mg/5mL
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68094-588	68094-588-62	D	Discontinued by firm		2026-10-12

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`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
68094-588-59	ML - Milliliter	68094-588	3c77dc69-e451-43c1-b0ff-66aa3dee6124	1	2014-06-03
68094-588-62	ML - Milliliter	68094-588	e81cec15-80e1-4d81-9024-e677b82f7ba8	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 [PRECISION DOSE INC.]	1
Acetaminophen	ACTIVE MOIETY	362O9ITL9D	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]	1
anhydrous citric acid	INACTIVE INGREDIENT	XF417D3PSL	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]	1
butylparaben	INACTIVE INGREDIENT	3QPI1U3FV8	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]	1
calcium sulfate	INACTIVE INGREDIENT	WAT0DDB505	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]	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
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]	1
D&C red NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]	1
FD&C blue NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]	1
high fructose corn syrup	INACTIVE INGREDIENT	XY6UN3QB6S	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]	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
sorbitol	INACTIVE INGREDIENT	506T60A25R	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]	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
68094-588-62	68094058862	3 TRAY in 1 CASE (68094-588-62) > 10 CUP, UNIT-DOSE in 1 TRAY > 10.15 mL in 1 CUP, UNIT-DOSE (68094-588-59)	3 tray	2014-04-23	2021-03-31	No	No	Current