Childrens Pain Relief Dye-Free

Product NDC: 67091-119
11-digit product format: 670910119
Labeler code: 67091
Product ID: 67091-119_407e049c-266e-4ecf-9a59-f4f77aace291
Type: HUMAN OTC DRUG
Nonproprietary name: Acteaminophen
Dosage form: SUSPENSION
Route: ORAL
Labeler: WinCo Foods, LLC
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2014-12-12
Substance: ACETAMINOPHEN
Active strength: 160 mg/5mL
NDC exclude flag: No
Listing certified through: 2027-12-31
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: Childrens Pain Relief Dye-Free
Listing expiration: 2027-12-31

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
5ee134b3-b8e9-4621-b0a1-a84d9867ccba	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67091-119-18	Childrens Pain Relief Dye-Free	1 in 1 CARTON	SUSPENSION	1		6
67091-119-18	Childrens Pain Relief Dye-Free	118 mL in 1 BOTTLE	SUSPENSION	118		6

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ACETAMINOPHEN	ACTIVE INGREDIENT	362O9ITL9D	CHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC]	1
ACETAMINOPHEN	ACTIVE MOIETY	362O9ITL9D	CHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC]	1
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	CHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC]	1
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	CHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC]	1
CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 50-100 MPA.S AT 1%)	INACTIVE INGREDIENT	6QM647NAYU	CHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	CHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	CHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC]	1
MALTITOL	INACTIVE INGREDIENT	D65DG142WK	CHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	CHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	CHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC]	1
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	CHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	CHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	CHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67091-119	CHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC]	6	Current NDC, Legacy NDC, 2 package rows	20240413_5ee134b3-b8e9-4621-b0a1-a84d9867ccba.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 17 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aspirin	ASPIRIN	Cardinal Health 110, LLC. DBA Leader	318cc982-23a9-4804-b6fb-248f772d7a38	2026-04-02	Warnings	Exact identifier application number: M013
Chewable Acetaminophen Childrens	ACETAMINOPHEN	Cardinal Health 110, LLC. DBA Leader	8a18565c-b84e-43f8-8e96-e1dbcc39f08b	2026-04-02	Warnings	Exact identifier application number: M013
Childrens Pain Reliever	ACETAMINOPHEN	H E B	c713556c-cb9e-4ed2-bc2f-49b3d6256c0f	2026-04-02	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Discount Drug Mart	4a1e9c79-5036-4c69-82f9-e48abc972b47	2026-04-02	Warnings	Exact identifier application number: M013
Wispirin	ASPIRIN	Wisdrug AG	4e70ec5e-d033-a525-e063-6394a90a5a93	2026-04-01	Warnings	Exact identifier application number: M013
Aspirin Regimen	ASPIRIN	Cardinal Health 110, LLC. DBA Leader	ef2d75ee-9ed7-4b53-adbc-2ec40364da63	2026-03-31	Warnings	Exact identifier application number: M013
Tension Headache Relief	ACETAMINOPHEN, CAFFEINE	Hi-Tech Nutraceuticals, LLC	b119ba37-0ee3-851a-e053-2995a90a85b1	2026-03-31	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	RMT HEALTH LLC	4dc7229d-c895-1f80-e063-6394a90abfc3	2026-03-30	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	PD-Rx Pharmaceuticals, Inc.	d1f05e56-c830-4f85-b685-2a5965d10a1c	2026-03-26	Warnings	Exact identifier application number: M013
M-PAP	ACETAMINOPHEN	Bryant Ranch Prepack	ad01aea6-4af3-469b-b99d-e1e66aa40e8d	2026-03-25	Warnings	Exact identifier application number: M013
aspirin	ASPIRIN	Meijer Distribution Inc	c550b92e-de54-4599-9534-bd3022b0a86d	2026-03-25	Warnings	Exact identifier application number: M013
Low Dose Aspirin	ASPIRIN	AmerisourceBergen (Good Neighbor Pharmacy) 46122	db187226-0770-4934-90a4-c6ca50bdecef	2026-03-25	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	804d4b63-1bbe-47c0-ad49-39ddbeade6a3	2026-03-25	Warnings	Exact identifier application number: M013
childrens pain and fever	ACETAMINOPHEN	HyVee Inc	9d9c2bf6-8660-4987-8794-936d3102da8d	2026-03-24	Warnings	Exact identifier application number: M013
Childrens Pain Reliever	ACETAMINOPHEN	BJWC (Berkley & Jensen / BJ's)	851228ea-eaf3-452b-a9ce-8cd244a0eaf3	2026-03-24	Warnings	Exact identifier application number: M013
FirstCare Childrens Pain Fever Acetaminophen	ACETAMINOPHEN 80 MG	USpharma Ltd	9fc05ba6-5667-457e-82c1-a8b4e16cadda	2026-03-23	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Aarkish Pharmaceuticals NJ Inc.	e5e9e1ce-666a-461f-8287-a4642902067c	2026-03-23	Warnings	Exact identifier application number: M013
Chewable Aspirin Low Dose	CHEWABLE ASPIRIN	Grocery Outlet	609c0389-8bed-4483-84fa-73ee73fdb4e4	2026-03-20	Warnings	Exact identifier application number: M013
Adult Low Dose Pain Reliever	ASPIRIN	TWIN MED LLC	a395acf4-f487-4c98-8c44-ca2aaaf72deb	2026-03-20	Warnings	Exact identifier application number: M013
Rapidol	ACETAMINOPHEN	Pharmadel LLC	3a210860-1fc1-e496-e063-6394a90a8705	2026-03-20	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	5ee134b3-b8e9-4621-b0a1-a84d9867ccba	6
307668	acetaminophen 32 MG/ML Oral Suspension	SCD	5ee134b3-b8e9-4621-b0a1-a84d9867ccba	6
307668	acetaminophen 160 MG per 5 ML Oral Suspension	SY	5ee134b3-b8e9-4621-b0a1-a84d9867ccba	6
307668	acetaminophen 320 MG per 10 ML Oral Suspension	SY	5ee134b3-b8e9-4621-b0a1-a84d9867ccba	6
307668	acetaminophen 650 MG per 20.3 ML Oral Suspension	SY	5ee134b3-b8e9-4621-b0a1-a84d9867ccba	6
307668	acetaminophen 80 MG per 2.5 ML Oral Suspension	SY	5ee134b3-b8e9-4621-b0a1-a84d9867ccba	6
307668	APAP 32 MG/ML Oral Suspension	SY	5ee134b3-b8e9-4621-b0a1-a84d9867ccba	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67091-119-18	67091011918	1 BOTTLE in 1 CARTON (67091-119-18) / 118 mL in 1 BOTTLE	1 bottle	2014-12-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Childrens Pain Relief Oral Suspension Dye-Free Grape	WinCo Foods, LLC	2024-04-11	HUMAN OTC DRUG LABEL	6