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
IngredientStrength
ACETAMINOPHEN160 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
307668Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5ee134b3-b8e9-4621-b0a1-a84d9867ccbaAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67091-119-18Childrens Pain Relief Dye-Free1 in 1 CARTONSUSPENSION16
67091-119-18Childrens Pain Relief Dye-Free118 mL in 1 BOTTLESUSPENSION1186

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DCHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DCHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLCHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8CHILDRENS 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 INGREDIENT6QM647NAYUCHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC]1
MALTITOLINACTIVE INGREDIENTD65DG142WKCHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4CHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RCHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEECHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67091-119CHILDRENS PAIN RELIEF DYE-FREE (ACTEAMINOPHEN) SUSPENSION [WINCO FOODS, LLC]6Current NDC, Legacy NDC, 2 package rows20240413_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 2 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MAX relief juniorACETAMINOPHENAkron Pharma Inc.0e43b885-3843-4f11-9a53-02a38c2283132026-08-31WarningsExact identifier
application number: M013
MAX relief juniorCHILDREN ACETAMINOPHENAkron Pharma Inc.d7874e4d-0b38-4bb1-9a62-aa4f66d9baf92026-08-31WarningsExact identifier
application number: M013
MAX relief junior GrapeCHILDREN ACETAMINOPHENAkron Pharma Inc.3c7a7f40-4963-4fd1-942e-93fa08a458302026-08-31WarningsExact identifier
application number: M013
Genexa Kids Pain and FeverACETAMINOPHENGenexa Inc.5a615118-33c9-1520-e063-6394a90a21a62026-08-31WarningsExact identifier
application number: M013
acetaminophen extra strengthACETAMINOPHENSam's West Incdd99efd0-4ca4-4dc6-a940-bebd17ac8f8d2026-08-28WarningsExact identifier
application number: M013
Aspirin 81 mgASPIRINHAWAII REPACK, INC.ac94cce3-9a39-41de-bb8b-10a5e5b8e83b2026-08-28WarningsExact identifier
application number: M013
AspirinASPIRINWinCo Foods, LLCa0a19cd1-eb8a-4773-be00-78de90d2a3c32026-08-28WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENFSA STORE INC.5502ef15-9f40-db56-e063-6394a90a2de42026-08-26WarningsExact identifier
application number: M013
Dye Free Pain and Fever ChildrensACETAMINOPHENWalgreens3ea217dd-e5b9-4d4b-861a-76ce61ba3a1d2026-08-26WarningsExact identifier
application number: M013
HyVee Extra Strength Headache Relief CAPLETACETAMINOPHEN, ASPIRIN, CAFFEINEHyVee Inc495c75bf-c09a-accd-e063-6294a90a75ec2026-08-24WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENWalgreens543f93d1-df14-0bd2-e063-6294a90a44132026-08-24WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENAkron Pharma Inc.ab79fd60-8315-4c63-8045-1b0511ac268f2026-08-24WarningsExact identifier
application number: M013
Genexa Infants Pain and FeverACETAMINOPHENGenexa Inc.4fd048c3-70bc-2ea7-e063-6394a90a55f22026-08-22WarningsExact identifier
application number: M013
Genexa Kids Pain and FeverACETAMINOPHENGenexa Inc.59adabeb-97e8-2de4-e063-6394a90acc472026-08-22WarningsExact identifier
application number: M013
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEPublix Super Markets Inca876daa7-ade3-497d-87bb-46d6e4dc185a2026-08-21WarningsExact identifier
application number: M013
equate aspirinASPIRINWal-Mart Stores Incea3f8eed-7b70-4156-9586-125d27bf29a82026-08-19WarningsExact identifier
application number: M013
aspirin chewable, low doseASPIRINUnited Natural Foods, Inc. dba UNFI6a6ac7fe-91a4-4b55-979a-b53b51505d8b2026-08-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENSam's West Inc1098d0e7-8202-4018-a2d2-b0c80ee58b562026-08-19WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINESafeway, Inc.5e77dca4-2ff8-4a8c-94bd-f224b680ca232026-08-19WarningsExact identifier
application number: M013
dg health pain relief pm extra strengthACETAMINOPHEN, DIPHENHYDRAMINE HCLDolgencorp Inc4d1eddf0-eff7-4c47-b312-30dee08d9e5f2026-08-19WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN5ee134b3-b8e9-4621-b0a1-a84d9867ccba6
307668acetaminophen 32 MG/ML Oral SuspensionSCD5ee134b3-b8e9-4621-b0a1-a84d9867ccba6
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY5ee134b3-b8e9-4621-b0a1-a84d9867ccba6
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY5ee134b3-b8e9-4621-b0a1-a84d9867ccba6
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY5ee134b3-b8e9-4621-b0a1-a84d9867ccba6
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY5ee134b3-b8e9-4621-b0a1-a84d9867ccba6
307668APAP 32 MG/ML Oral SuspensionSY5ee134b3-b8e9-4621-b0a1-a84d9867ccba6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67091-119-18670910119181 BOTTLE in 1 CARTON (67091-119-18) / 118 mL in 1 BOTTLE1 bottle2014-12-120000-00-00NoNoCurrent