Childrens Pain and Fever

Product NDC
51316-282
11-digit product format
513160282
Labeler code
51316
Product ID
51316-282_ab8177f3-4a0d-4630-879d-6835c621dece
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
CVS PHARMACY, INC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-02-15
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 and Fever
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
fdc80b2a-d7c1-4b3d-9a9b-28182c6320deAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-282-04Childrens Pain and Fever1 in 1 BOXSUSPENSION12
51316-282-04Childrens Pain and Fever118 mL in 1 BOTTLE, PLASTICSUSPENSION1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-282CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CVS PHARMACY, INC]2Current NDC, 2 package rows20240316_fdc80b2a-d7c1-4b3d-9a9b-28182c6320de.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 56 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Publix Fast Relief EffervescentASPIRIN, CITRIC ACID, SODIUM BICARBONATEPublix Super Markets Inc.73051f16-2569-7394-e053-2991aa0a53592024-11-13WarningsExact identifier
application number: M013
Quality Choice Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEChain Drug Marketing Association70d265de-ff94-e0e4-e053-2a91aa0a962a2024-11-13WarningsExact identifier
application number: M013
Quality Choice Extra Strength Effervescent Antacid and Pain ReliefASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATEChain Drug Marketing Association9f7d0c96-a561-a8a0-e053-2995a90a250b2024-11-13WarningsExact identifier
application number: M013
WinCo Foods Effervescent Antacid and Pain ReliefASPIRIN, SODIUM BICARBONATE, CITRIC ACID TABLETWinCo Foods, LLC0c8a755a-089f-477f-97e9-0dd6fdfbe99d2024-11-13WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENKroger Company8fb19444-f0e0-4d26-81e8-6a4b835056d82024-11-12WarningsExact identifier
application number: M013
equate pain relieverACETAMINOPHENWALMART INC.59d01f72-4575-48e2-b914-b6a6456ca7d22024-11-11WarningsExact identifier
application number: M013
pain and feverACETAMINOPHENKroger Companyd181560c-1c39-4f2e-8a17-996224ca040f2024-11-09WarningsExact identifier
application number: M013
Childrens TylenolACETAMINOPHENKenvue Brands LLCbabcb210-6a47-46ef-b4ea-bdde80411cd32024-11-08WarningsExact identifier
application number: M013
Bayer Genuine AspirinASPIRINAcme United Corporationf7f9dc46-a945-7ae3-e053-6394a90a11922024-11-08WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLCdd87e342-b0cb-4111-9f15-415dbcda4b772024-11-07WarningsExact identifier
application number: M013
Tylenol Extra StrengthACETAMINOPHENKenvue Brands LLC0c5fdda8-5049-46de-e063-6294a90a592b2024-11-07WarningsExact identifier
application number: M013
Childrens TYLENOLACETAMINOPHENKenvue Brands LLC46ddbfde-54ab-4373-b832-b9c0620b1e9d2024-11-07WarningsExact identifier
application number: M013
Childrens TYLENOLACETAMINOPHENKenvue Brands LLC333f6231-3778-4c1f-9558-2afddca22c862024-11-07WarningsExact identifier
application number: M013
Childrens TYLENOLACETAMINOPHENKenvue Brands LLC34247a3b-0846-4086-becd-76e630b3b7212024-11-07WarningsExact identifier
application number: M013
Childrens TYLENOLACETAMINOPHENKenvue Brands LLCa51c2deb-c703-4dc8-9255-8ac9fe6351702024-11-07WarningsExact identifier
application number: M013
Childrens TYLENOLACETAMINOPHENKenvue Brands LLCce0a1fbc-7345-462b-b0da-c7149bdc288c2024-11-07WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC015a6179-bacb-452d-b594-4de628ddc11d2024-11-07WarningsExact identifier
application number: M013
TYLENOL Regular StrengthACETAMINOPHENKenvue Brands LLCde5c6654-56c5-40d3-a286-f04ed47ac7c82024-11-07WarningsExact identifier
application number: M013
Midol CompleteACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATEAcme United Corporationf7bf126d-a6f1-231a-e053-6294a90a04e12024-11-07WarningsExact identifier
application number: M013
CareOne Childrens AcetaminophenACETAMINOPHENAmerican Sales Company49021ae8-9655-4885-9f74-52df4cdcb26f2024-11-07WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNfdc80b2a-d7c1-4b3d-9a9b-28182c6320de2
307668acetaminophen 32 MG/ML Oral SuspensionSCDfdc80b2a-d7c1-4b3d-9a9b-28182c6320de2
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYfdc80b2a-d7c1-4b3d-9a9b-28182c6320de2
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYfdc80b2a-d7c1-4b3d-9a9b-28182c6320de2
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYfdc80b2a-d7c1-4b3d-9a9b-28182c6320de2
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYfdc80b2a-d7c1-4b3d-9a9b-28182c6320de2
307668APAP 32 MG/ML Oral SuspensionSYfdc80b2a-d7c1-4b3d-9a9b-28182c6320de2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51316-282-04513160282041 BOTTLE, PLASTIC in 1 BOX (51316-282-04) / 118 mL in 1 BOTTLE, PLASTIC2023-02-15NoNoCurrent