Dye Free Childrens Acetaminophen

Product NDC: 68094-061
11-digit product format: 680940061
Labeler code: 68094
Product ID: 68094-061_046ba40e-c1d0-4bdf-b8c9-fc46c1a6ed19
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: 2022-08-02
Substance: ACETAMINOPHEN
Active strength: 160 mg/5mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 6 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
2025-01-20 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	68094-061-62	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68094-061-61	`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	68094-061-62	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68094-061-61	`0efc9e666f02…`	`f202fb6c5f17…`

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: Dye Free Childrens 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
5cc698fa-0841-4851-ae21-0aac8b40eb0a	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68094-061-59	Dye Free Childrens Acetaminophen	5 mL in 1 CUP, UNIT-DOSE	SUSPENSION	5	4
68094-061-61	Dye Free Childrens Acetaminophen	10 in 1 TRAY	SUSPENSION	10	4
68094-061-61	Dye Free Childrens Acetaminophen	10 in 1 CASE	SUSPENSION	10	4
68094-061-62	Dye Free Childrens Acetaminophen	3 in 1 CASE	SUSPENSION	3	4
68094-061-62	Dye Free Childrens Acetaminophen	10 in 1 TRAY	SUSPENSION	10	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68094-061-59	ML - Milliliter	68094-061	7ffde884-046e-4467-bf19-e6963019ceeb	1	2022-09-12
68094-061-61	ML - Milliliter	68094-061	01f444ad-976b-4dee-a6d8-58370a3ce676	1	2022-09-12
68094-061-62	ML - Milliliter	68094-061	96850414-3946-419e-af60-8205fe94744c	1	2022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68094-061	DYE FREE CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PRECISION DOSE INC.]	4	Current NDC, Legacy NDC, 5 package rows	20250122_5cc698fa-0841-4851-ae21-0aac8b40eb0a.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 29 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Regular Strength Pain Relief	ACETAMINOPHEN	VALU MERCHANDISERS COMPANY	f7e87eac-59fb-4a72-b5c6-02953112be6a	2025-12-11	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	VALU MERCHANDISERS COMPANY	049ec1aa-66b3-9273-e063-6294a90a221b	2025-12-11	Warnings	Exact identifier application number: M013
Aspirin 325	ASPIRIN	Walgreen Company	f7a5d612-443c-4701-ad3b-8eb53c87bece	2025-12-11	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	PAI Holdings, LLC dba PAI Pharma	355a094c-bed9-4959-8cf0-619f0e246105	2025-12-11	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	PAI Holdings, LLC dba PAI Pharma	fac4e0c6-684f-45a1-99f2-de4de4017cc8	2025-12-11	Warnings	Exact identifier application number: M013
Pain Reliever PM extra strength	ACETAMINOPHEN DIPHENHYDRAMINE HCL	P & L Development, LLC	90eba2e8-52c3-43f5-ba93-4a520368c7f4	2025-12-11	Warnings	Exact identifier application number: M013
Midol Complete, Travel BASIX	ACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATE	Lil' Drug Store Products, Inc	d6d47af8-5f8c-4c8c-a8c6-aa214ec23bca	2025-12-10	Warnings	Exact identifier application number: M013
Tylenol PM Extra Strength, CVP HEALTH	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	Lil' Drug Store Products, Inc.	643371f2-e330-441e-8932-b3aec4b179d2	2025-12-10	Warnings	Exact identifier application number: M013
Low Dose Aspirin	ASPIRIN	United Natural Foods, Inc. dba UNFI	18b79449-5c4c-41ce-9609-80f5efa0375c	2025-12-09	Warnings	Exact identifier application number: M013
Pain Relief	ACETAMINOPHEN	AAA Pharmaceutical, Inc.	36ad34f4-4e66-f371-e063-6394a90ae76a	2025-12-09	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	LIDL US LLC	ec543339-20ab-2cba-e053-2995a90ac740	2025-12-09	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION, INC.	c57c10fc-f182-4153-8974-ef359a5f5ac1	2025-12-09	Warnings	Exact identifier application number: M013
Pain Relief PM Extra Strength	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	HEB	f7958347-4e9c-4698-8749-7ca7023ee2ba	2025-12-09	Warnings	Exact identifier application number: M013
Pain Relief Rapid Release Gelcaps Extra Strength	ACETAMINOPHEN	Safeway	c830d1ac-c4c5-4eb1-98bb-22707cb6db91	2025-12-09	Warnings	Exact identifier application number: M013
Menstrual Pain Relief Complete	ACETAMINOPHEN, PYRILAMINE MALEATE, CAFFEINE	Shield Pharmaceuticals Corp	5efd6c61-74ed-4253-896a-e4a40bd8f25b	2025-12-09	Warnings	Exact identifier application number: M013
Excedrin Extra Strength, TRAVEL BASIX	ACETAMINOPHEN, ASPIRIN, AND CAFFEINE	Lil Drug Store Products, Inc	7f0f8b3c-c226-4a3a-af46-a708f345e4f5	2025-12-09	Warnings	Exact identifier application number: M013
childrens acetaminophen	ACETAMINOPHEN	United Natural Foods, Inc. dba UNFI	f65203a2-64f0-4138-97e4-6eab99194178	2025-12-09	Warnings	Exact identifier application number: M013
Pain Reliever PM, Extra Strength, 24-7 Life by 7-Eleven	ACETAMINOPHEN, DIPHENHYDRAMINE HCL TABLET, FILM COATED	Lil' Drug Store Products, Inc.	45735cd8-ac07-3f12-e063-6294a90a0cb2	2025-12-08	Warnings	Exact identifier application number: M013
BERKLEY AND JENSEN RAPID RELEASE ACETAMINOPHEN	ACETAMINOPHEN	BJWC	e27b6637-ef32-44b5-a531-b6617d02fbbf	2025-12-08	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	WALGREENS	3f9f1740-9e8b-6a2d-e063-6294a90a67cb	2025-12-06	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	5cc698fa-0841-4851-ae21-0aac8b40eb0a	4
307668	acetaminophen 32 MG/ML Oral Suspension	SCD	5cc698fa-0841-4851-ae21-0aac8b40eb0a	4
307668	acetaminophen 160 MG per 5 ML Oral Suspension	SY	5cc698fa-0841-4851-ae21-0aac8b40eb0a	4
307668	acetaminophen 320 MG per 10 ML Oral Suspension	SY	5cc698fa-0841-4851-ae21-0aac8b40eb0a	4
307668	acetaminophen 650 MG per 20.3 ML Oral Suspension	SY	5cc698fa-0841-4851-ae21-0aac8b40eb0a	4
307668	acetaminophen 80 MG per 2.5 ML Oral Suspension	SY	5cc698fa-0841-4851-ae21-0aac8b40eb0a	4
307668	APAP 32 MG/ML Oral Suspension	SY	5cc698fa-0841-4851-ae21-0aac8b40eb0a	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68094-061-59	68094006159	5 mL in 1 CUP, UNIT-DOSE	5 ml					Historical
68094-061-61	68094006161	10 TRAY in 1 CASE (68094-061-61) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-061-59)	10 tray	2022-08-02	0000-00-00	No	No	Current
68094-061-62	68094006162	3 TRAY in 1 CASE (68094-061-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-061-59)	3 tray	2022-08-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DYE FREE CHILDREN'S ACETAMINOPHEN ORAL SUSPENSION	Precision Dose Inc.	2025-01-16	HUMAN OTC DRUG LABEL	4