FDA.reportPublic FDA data

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 19 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aspirin Regular StrengthASPIRINRite Aid Corporation879e2258-f61b-47ad-a4b1-7d1e788235702026-03-05WarningsExact identifier
application number: M013
AspirinASPIRINARMY AND AIR FORCE EXCHANGE SERVICE87c580d3-6009-4be9-aea7-13539fbe6e312026-03-05WarningsExact identifier
application number: M013
Aspirin Low Dose Chewable OrangeASPIRINMAJOR PHARMACEUTICALSfb3a8e38-e991-49c9-93dc-1d29c0a97ba32026-03-05WarningsExact identifier
application number: M013
Infants Pain and FeverACETAMINOPHENKroger41e149df-4140-95cc-e063-6294a90a866b2026-03-03WarningsExact identifier
application number: M013
Medique Pain OffACETAMINOPHEN, ASPIRIN, CAFFEINESportpharm LLC2b35acdc-ff88-46e6-a108-5240aac1d53f2026-03-03WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENBest Choice (Valu Merchandisers Company)a8a0d9a5-1a36-4ed2-ae9c-7e1a3d674c072026-03-03WarningsExact identifier
application number: M013
pain reliefACETAMINOPHENHyVee Inc6820a515-4004-407b-969b-c4069dc0c3b52026-02-26WarningsExact identifier
application number: M013
Acetaminophen, Diphenhydramine HydrochlorideACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDELEADER/ Cardinal Health 110, Inc.7be4d67e-1af9-f059-e053-2991aa0a382e2026-02-26WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENNCS HealthCare of KY, LLC dba Vangard Labsf32fc2e9-c0e3-4a25-8399-9cdba6ae8a162026-02-26WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENNCS HealthCare of KY, LLC dba Vangard Labs1f4ac0e6-e986-4c22-8248-0691d64e1a302026-02-26WarningsExact identifier
application number: M013
Childrens Chewable AcetaminophenACETAMINOPHENDiscount Drug Martf413a617-1166-4940-b6ec-fae32238a7802026-02-26WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENNCS HealthCare of KY, LLC dba Vangard Labs19735691-33f3-4e19-85ad-e5f270251ec52026-02-26WarningsExact identifier
application number: M013
Acetaminophen Liquid / Acetaminophen Diphenhydramine HCl LiquidACETAMINOPHEN, DIPHENHYDRAMINE HCLKroger44520aa1-b63f-4239-e063-6394a90a5e142026-02-25WarningsExact identifier
application number: M013
Leader Extra Strength Effervescent Antacid and Pain RelieverASPIRIN, CITRIC ACID, SODIUM BICARBONATECardinal Healthc5d7bf5f-3e59-52f2-e053-2a95a90a4a002026-02-25WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED12fd643d-7c60-453f-a81f-407ed20e87252026-02-25WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDd96a1531-772b-4a5c-89e4-66fff1fa3d782026-02-25WarningsExact identifier
application number: M013
Gentle Care KitZINC OXIDEKenvue Brands LLC4b8f7a5a-2fc4-ea00-e063-6294a90ab95b2026-02-24WarningsExact identifier
application number: M013
Excedrin PM Triple Action Caplets and Excedrin Extra Strength Pain RelieverACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE, AND DIPHENHYDRAMINE CITRATEHaleon US Holdings LLC444fa225-c204-45d1-b3b3-aa5650ee5d072026-02-23WarningsExact identifier
application number: M013
Excedrin Extra Strength and Excedrin Tension HeadacheACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINEHaleon US Holdings LLC2c8df1c7-7864-48df-939c-d9ae22e0f52c2026-02-23WarningsExact identifier
application number: M013
Equate Childrens Pain and FeverACETAMINOPHENWal-Mart Stores Inc40eedfe9-54e1-40a2-b4a2-55ff708b89cd2026-02-23WarningsExact 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