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 73 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PANADOL Extra	ACETAMINOPHEN AND CAFFEINE	Haleon US Holdings LLC	e5c2d88a-d903-4ca0-b895-f27e791dfc4e	2024-02-06	Warnings	Exact identifier application number: M013
PANADOL Extra Strength	ACETAMINOPHEN	Haleon US Holdings LLC	b2fe7f47-1a2e-40ee-8f8f-38f2028dce1b	2024-02-06	Warnings	Exact identifier application number: M013
PANADOL Extra Strength	ACETAMINOPHEN	Haleon US Holdings LLC	9d384e88-5c11-4600-ac6c-a38371570138	2024-02-06	Warnings	Exact identifier application number: M013
PANADOL	ACETAMINOPHEN	Haleon US Holdings LLC	95801755-db54-4ad7-bec1-52671914f6ca	2024-02-06	Warnings	Exact identifier application number: M013
PANADOL PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HCL	Haleon US Holdings LLC	01e7dddb-755c-4745-b701-edcdb6209064	2024-02-06	Warnings, Adverse reactions	Exact identifier application number: M013
PANADOL PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HCL	Haleon US Holdings LLC	fe7cd1f2-9b00-4ded-99c2-8a152c71093c	2024-02-06	Warnings, Adverse reactions	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	AptaPharma Inc.	9064943f-836f-4853-b6f2-2c4879941eeb	2024-02-02	Warnings	Exact identifier application number: M013
Quality Choice Effervescent Pain Relief	ASPIRIN	CHAIN DRUG MARKETING ASSOCIATION, INC.	079af5d7-1be8-2a93-e063-6294a90a496d	2024-02-01	Warnings	Exact identifier application number: M013
MEDI-FIRST Non-Aspirin	ACETAMINOPHEN	Proficient Rx LP	4c84948d-3a95-4c53-8529-7e7b9d8bb6df	2024-02-01	Warnings	Exact identifier application number: M013
Pharbetol	ACETAMINOPHEN	Proficient Rx LP	9c7d65e4-df2f-47c1-a185-66aaf19aad2b	2024-02-01	Warnings	Exact identifier application number: M013
Childrens Acetaminophen	ACETAMINOPHEN	Proficient Rx LP	57e4820c-b4eb-442e-9c49-93eedfbc5e5e	2024-02-01	Warnings	Exact identifier application number: M013
good sense aspirin	ASPIRIN	Proficient Rx LP	73013074-9c6e-43c7-acde-4d9d8ed0133d	2024-02-01	Warnings	Exact identifier application number: M013
MEDIQUE APAP Extra Strength	ACETAMINOPHEN	Proficient Rx LP	c466a07f-2339-4cf5-8377-e0f109649c52	2024-02-01	Warnings	Exact identifier application number: M013
Percogesic Extra Strength	ACETAMINOPHEN AND DIPHENHYDRAMINE	Medtech Products Inc.	2c5f1140-fb83-42c9-b0b1-5e2bd69340bb	2024-02-01	Warnings	Exact identifier application number: M013
aspirin	ASPIRIN	Proficient Rx LP	3c7783a7-2b28-4968-b766-0a49dc70ce6d	2024-02-01	Warnings	Exact identifier application number: M013
Regular Strength Pain Relief	ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	102bdcde-cb90-f248-e063-6394a90aac79	2024-01-30	Warnings	Exact identifier application number: M013
Excedrin Extra Strength Headache	ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE	Haleon US Holdings LLC	61802b27-c9ec-4386-9d44-45e8b1e558b7	2024-01-28	Warnings	Exact identifier application number: M013
AGRIFEN	ACETAMINOPHEN, ASPIRIN, CAFFEINE	OPMX LLC	0fde22da-cdfc-36cc-e063-6294a90a3885	2024-01-26	Warnings	Exact identifier application number: M013
DOLODOL	ACETAMINOPHEN, ASPIRIN, CAFFEINE	OPMX LLC	e80536f1-92cc-5bb3-e053-2995a90a9540	2024-01-26	Warnings	Exact identifier application number: M013
LOW DOSE ASPIRIN	ASPIRIN	Bryant Ranch Prepack	d913d11f-c7a1-49d2-a2d3-9a29fc032806	2024-01-18	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