FDA.reportPublic FDA data

Dye Free Pain and Fever

Product NDC
0363-0285
11-digit product format
003630285
Labeler code
0363
Product ID
0363-0285_421aef3f-95c5-47ac-bd38-39b5c74d8c67
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Walgreens
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-03-31
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
Dye Free Pain and Fever
Brand name suffix
Childrens
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
c6665c11-9a01-4472-a444-acadb1de0b69Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0285-04Dye Free Pain and FeverChildrens118 mL in 1 BOTTLE, PLASTICSUSPENSION1188
0363-0285-04Dye Free Pain and FeverChildrens1 in 1 BOXSUSPENSION18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0285-04ML - Milliliter0363-02852d229cfb-fba7-4704-9996-1446d8591ecd12022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DDYE FREE PAIN AND FEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [WALGREENS]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DDYE FREE PAIN AND FEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [WALGREENS]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLDYE FREE PAIN AND FEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [WALGREENS]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8DYE FREE PAIN AND FEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [WALGREENS]1
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMINACTIVE INGREDIENTK679OBS311DYE FREE PAIN AND FEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [WALGREENS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDYE FREE PAIN AND FEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [WALGREENS]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDYE FREE PAIN AND FEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [WALGREENS]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SDYE FREE PAIN AND FEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [WALGREENS]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DYE FREE PAIN AND FEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [WALGREENS]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUDYE FREE PAIN AND FEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [WALGREENS]1
SORBITOLINACTIVE INGREDIENT506T60A25RDYE FREE PAIN AND FEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [WALGREENS]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4DYE FREE PAIN AND FEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [WALGREENS]1
WATERINACTIVE INGREDIENT059QF0KO0RDYE FREE PAIN AND FEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [WALGREENS]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEDYE FREE PAIN AND FEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [WALGREENS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0285DYE FREE PAIN AND FEVER CHILDRENS (ACETAMINOPHEN) SUSPENSION [WALGREENS]8Current NDC, Legacy NDC, 2 package rows20240618_c6665c11-9a01-4472-a444-acadb1de0b69.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 20 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Excedrin Rapid ReliefACETAMINOPHENHaleon US Holdings LLC3a36b7ca-396e-cfd8-e063-6294a90a76ab2026-02-22WarningsExact identifier
application number: M013
CHILDRENS AcetaminophenCHILDRENS ACETAMINOPHENKesin Pharma Corporation4af5b025-1fd7-e825-e063-6294a90aa0052026-02-16WarningsExact identifier
application number: M013
Infants TYLENOLACETAMINOPHENKenvue Brands LLC4a121a53-dbae-05c7-e063-6294a90aed892026-02-13WarningsExact identifier
application number: M013
MAX relief junior GrapeCHILDRENS ACETAMINOPHENATLANTIC BIOLOGICALS CORP.562d7901-44d6-4d9b-be8b-a8d468a22c432026-02-13WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENMajor Pharmaceuticals020fa486-31f0-4e0c-84d3-5b3aaded1eeb2026-02-13WarningsExact identifier
application number: M013
ASPIRIN Low StrengthASPIRINCVS Pharmacy6e1c1129-562b-4a8a-ac37-db3cb2a827352026-02-11WarningsExact identifier
application number: M013
CVS AcetaminophenACETAMINOPHENCVS Pharmacy3dd21aaf-13b2-9e81-e063-6294a90afaec2026-02-11WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN, ASPIRIN, DIPHENHYDRAMINE CITRATECVS Pharmacyddd78b28-6e10-4708-bed1-8aea087b3d822026-02-11WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENTopco Associates, LLC2e31fe65-5f50-455b-99fa-c72879f435452026-02-10WarningsExact identifier
application number: M013
Pain Relief ChildrensACETAMINOPHENAmerisource Bergen9ea8bb1f-1924-4430-98bd-f2674d0da7482026-02-09WarningsExact identifier
application number: M013
Acetaminophen , Caffeine and pyrilamine maleateACETAMINOPHEN , CAFFEINE AND PYRILAMINE MALEATESoftgel Healthcare Pvt Ltd4a61313e-1b48-29df-e063-6394a90a27f02026-02-09WarningsExact identifier
application number: M013
good sense aspirinASPIRINL. Perrigo Companye9fddbc1-11fe-4cf6-8794-1650fa1b32ae2026-02-07WarningsExact identifier
application number: M013
AspirinASPIRINChain Drug Marketing Association, Inc.2d375ec9-a528-4048-a15b-652fa20e74a72026-02-06WarningsExact identifier
application number: M013
Adult Low Dose Enteric Coated AspirinASPIRINSportpharm LLCd3379569-7949-4f78-b634-5d4178b21ea42026-02-06WarningsExact identifier
application number: M013
Buffered AspirinASPIRINCardinal Health 110, LLC. DBA Leadere5f68c1a-21f3-45a1-861f-229a95b3721c2026-02-06WarningsExact identifier
application number: M013
pain relief extra strengthACETAMINOPHENHyVee Inc1e707628-08b1-4c72-b71c-2b4ae96071f22026-02-06WarningsExact identifier
application number: M013
CareOne Acetaminophen PMACETAMINOPHEN, DIPHENHYDRAMINE HCLAmerican Sales Company2d2ded37-f241-4976-886d-5c038a85bfe12026-02-05WarningsExact identifier
application number: M013
Dolex FemACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEPharmadel LLCb1cab10b-19f1-f5d5-e053-2995a90a4d5f2026-02-05WarningsExact identifier
application number: M013
Alka-Seltzer Extra Strength Pain ReliefANHYDROUS CITRIC ACID, ASPIRINBayer HealthCare LLC.4a16b6e5-f0c6-e3a4-e063-6294a90a85ad2026-02-05WarningsExact identifier
application number: M013
Pain Relief childrensACETAMINOPHENCVS PHARMACYb8ab85a6-3eab-4ef4-a13d-5ac300480f632026-02-03WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNc6665c11-9a01-4472-a444-acadb1de0b698
307668acetaminophen 32 MG/ML Oral SuspensionSCDc6665c11-9a01-4472-a444-acadb1de0b698
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYc6665c11-9a01-4472-a444-acadb1de0b698
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYc6665c11-9a01-4472-a444-acadb1de0b698
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYc6665c11-9a01-4472-a444-acadb1de0b698
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYc6665c11-9a01-4472-a444-acadb1de0b698
307668APAP 32 MG/ML Oral SuspensionSYc6665c11-9a01-4472-a444-acadb1de0b698

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-0285-04003630285041 BOTTLE, PLASTIC in 1 BOX (0363-0285-04) / 118 mL in 1 BOTTLE, PLASTIC2015-03-310000-00-00NoNoCurrent