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 49 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Low dose Aspirin	ASPIRIN 81 MG DELAYED RELEASE TABLETS	WALGREENS	c25c3524-3e24-3410-e053-2995a90a73ed	2025-01-30	Warnings	Exact identifier application number: M013
HEADACHE RELIEF	ACETAMINOPHEN, ASPIRIN, CAFFEINE	WALGREENS	b5a45daa-05b1-4d6d-e053-2995a90a8444	2025-01-30	Warnings	Exact identifier application number: M013
Aspirin 81	ASPIRIN	WALGREENS	d71a571e-e2ce-7e0a-e053-2a95a90a53e0	2025-01-30	Warnings	Exact identifier application number: M013
Regular strength aspirin	ASPIRIN	TARGET CORPORATION	e8c87ccb-8c0c-7830-e053-2995a90a88b7	2025-01-30	Warnings	Exact identifier application number: M013
Multi-Symptom Menstrual Relief	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	TARGET	2368ac1b-d644-9908-e063-6394a90a4b89	2025-01-29	Warnings	Exact identifier application number: M013
Pain Reliever Extra Strength	ACETAMINOPHEN	Walgreen Company	28e275fb-d615-4725-998c-946fe1bfdc0c	2025-01-29	Warnings	Exact identifier application number: M013
Childrens Acetaminophen	ACETAMINOPHEN	Major Pharmaceuticals	38b839b6-de7d-4f33-a19a-efc92cdad92c	2025-01-24	Warnings	Exact identifier application number: M013
good sense pain relief	ACETAMINOPHEN	Preferred Pharmaceuticals Inc.	523b68da-cd2a-4960-95e7-de5d51ce33c1	2025-01-23	Warnings	Exact identifier application number: M013
Safety Coated Aspirin 81 mg Low Dose	ASPIRIN 81MG	Ulai Health LLC	3d225a11-a53b-4dc2-9c25-13cab007900f	2025-01-20	Warnings	Exact identifier application number: M013
Pharbetol	ACETAMINOPHEN 325 MG	Ulai Health LLC	55bb7e6c-e98c-48bd-b7bb-9848ff0273ca	2025-01-20	Warnings	Exact identifier application number: M013
ACETAMINOPHEN PM	ACETAMINOPHEN 500MG / DIPHENHYDRAMINE HCL 25MG	Ulai Health LLC	d4a568c9-a721-48d1-aebc-fc65444947ce	2025-01-20	Warnings	Exact identifier application number: M013
Pharbetol	ACETAMINOPHEN 500MG	Ulai Health LLC	c9d3cee1-531c-439f-ae19-07acd366aad6	2025-01-20	Warnings	Exact identifier application number: M013
Percogesic Original Strength	ACETAMINOPHEN AND DIPHENHYDRAMINE HCL	Medtech Products Inc.	529974c2-0121-4892-8e47-c2c447581091	2025-01-17	Warnings	Exact identifier application number: M013
Little Remedies Childrens Fever Pain Reliever	ACETAMINOPHEN	Medtech Products Inc.	e1e44c85-d10c-4997-8f85-064cda7906eb	2025-01-17	Warnings	Exact identifier application number: M013
Stanback	ASPIRIN AND CAFFEINE	Medtech Products Inc.	caaa1313-09e4-45aa-8836-346f6a370196	2025-01-17	Warnings	Exact identifier application number: M013
Dye Free Childrens Acetaminophen	ACETAMINOPHEN	Precision Dose Inc.	5cc698fa-0841-4851-ae21-0aac8b40eb0a	2025-01-16	Warnings	Exact identifier application number: M013 ndc (product): 68094-061
Ecotrin	ASPIRIN	Medtech Products Inc.	222d187b-aae6-410b-baeb-b2bd42f5c676	2025-01-16	Warnings	Exact identifier application number: M013
Children Pain and Fever Reliever	ACETAMINOPHEN	Target Corporation	0dd643a4-3cbc-423d-95b4-ba373b09d895	2025-01-16	Warnings	Exact identifier application number: M013
Chewable Low Dose Aspirin	ASPIRIN	TARGET CORPORATION	f934e72a-2e9f-da17-e053-6394a90a1a2e	2025-01-15	Warnings	Exact identifier application number: M013
ACETAMINOPHEN 500 MG	ACETAMINOPHEN	Reliable 1 Laboratories LLC	2651bf11-4d66-43ba-e054-00144ff88e88	2025-01-15	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