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 51 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pediacare Childrens Acetaminophen Grape	ACETAMINOPHEN	RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH	596372c7-eca3-4527-8e22-ab0751e2526b	2024-12-30	Warnings	Exact identifier application number: M013
Bayer Genuine Aspirin	BAYER GENUINE ASPIRIN	Lil' Drug Store Products, Inc.	d17834d7-cb3e-6bf2-e053-2a95a90ae5c1	2024-12-30	Warnings	Exact identifier application number: M013
Extra Strength Pain Reliever	ACETAMINOPHEN 500 MG, FILM-COATED CAPLET	Lil' Drug Store Products, Inc.	e5fd2b46-683e-4cf5-e053-2995a90a5512	2024-12-30	Warnings	Exact identifier application number: M013
Night Time Severe Cold and Cough Relief	ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	Chain Drug Consortium, LLC	c8e9b57b-83e9-46c5-9791-02c4c2b94004	2024-12-29	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION INC.	1608b4f0-bf20-4024-b8f2-20a4df7a4b21	2024-12-26	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Advance Pharmaceutical Inc.	f6a9ea44-08b8-4a33-bfbd-68cb2d852c39	2024-12-26	Warnings	Exact identifier application number: M013
ACETAMINOPHEN	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION INC	cfc7eac3-35be-4002-b8ef-be1dfc8caf69	2024-12-26	Warnings	Exact identifier application number: M013
ACETAMINOPHEN	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION INC	a3031139-4709-43f2-95a8-89840c595f7f	2024-12-26	Warnings	Exact identifier application number: M013
Acetaminophen 250mg Aspirin 250mg Caffeine 65mg	ACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MG	WALGREENS CO.	98bb28ed-d146-ca3d-e053-2a95a90a9eaf	2024-12-26	Warnings	Exact identifier application number: M013
Acetaminophen 500mg Caffeine 60mg Pyrilamine maleate 15mg	ACETAMINOPHEN 500MG CAFFEINE 60MG PYRILAMINE MALEATE 15MG	WALGREENS CO.	982faa74-d498-cd1e-e053-2995a90afa1e	2024-12-25	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	AptaPharma Inc.	11bf6e1b-aed9-4f8f-9f03-ea911ae9f702	2024-12-23	Warnings	Exact identifier application number: M013
Rugby Regular Strength Acetaminophen	ACETAMINOPHEN	RUGBY LABORATORIES	295b0d00-4d4a-405f-9325-d01c5d4f3ed4	2024-12-20	Warnings	Exact identifier application number: M013
Walgreens Pain Relief Powder	ASPIRIN AND CAFFEINE	Walgreens Co.	61493d34-2432-4683-9b32-e1851a4337be	2024-12-18	Warnings	Exact identifier application number: M013
Reese Headache Powders	ASPIRIN AND CAFFEINE	Reese Pharmaceutical Co	386f7a6c-4bfc-4140-a67b-07f6b520d58f	2024-12-18	Warnings	Exact identifier application number: M013
NobleAid PAIN RELIEVER	ASPIRIN	Noble Otc LLC	aa08e488-2f69-4d7e-86ba-ccfad563edcf	2024-12-18	Warnings	Exact identifier application number: M013
Dollar General Headache Powders	ASPIRIN AND CAFFEINE	Dolgencorp, LLC	11b0271b-d65c-49c4-a081-d71044a0e04c	2024-12-18	Warnings	Exact identifier application number: M013
Family Wellness Pain Relief Powder	ASPIRIN AND CAFFEINE	Family Dollar Services Inc	b2e55de7-3c36-49cc-8f7f-1013fd1ec359	2024-12-18	Warnings	Exact identifier application number: M013
Best Choice Pain Relief Powder	ASPIRIN AND CAFFEINE	Value Merch	a95b9b22-ea5c-4a02-b35d-c8ae1e117604	2024-12-18	Warnings	Exact identifier application number: M013
Walmart Pain Relief Powder	ASPIRIN AND CAFFEINE	Walmart	c69aa61f-6a74-40a3-8737-195fa545e261	2024-12-18	Warnings	Exact identifier application number: M013
Quality Choice Pain Relief Powder	ASPIRIN AND CAFFEINE	Chain Drug Marketing Association	8e1f4057-4968-4523-9b3f-55aea421b674	2024-12-18	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