FDA.reportPublic FDA data

infants pain and fever

Product NDC
51316-606
11-digit product format
513160606
Labeler code
51316
Product ID
51316-606_0c6debb1-f4f9-483b-aba7-43f1ae5d2bc6
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-25
Marketing end
2026-12-31
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
NDC exclude flag
No
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
infants pain and fever

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN160 mg/5mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-606-16infants pain and fever1 in 1 CARTONSUSPENSION13
51316-606-16infants pain and fever59 mL in 1 BOTTLESUSPENSION593

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-606INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]2Current NDC, 2 package rows20240405_c7a2b7b7-a2db-49e1-bef6-d3a0f12e6e0d.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 SuspensionPSNc7a2b7b7-a2db-49e1-bef6-d3a0f12e6e0d3
307668acetaminophen 32 MG/ML Oral SuspensionSCDc7a2b7b7-a2db-49e1-bef6-d3a0f12e6e0d3
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYc7a2b7b7-a2db-49e1-bef6-d3a0f12e6e0d3
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYc7a2b7b7-a2db-49e1-bef6-d3a0f12e6e0d3
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYc7a2b7b7-a2db-49e1-bef6-d3a0f12e6e0d3
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYc7a2b7b7-a2db-49e1-bef6-d3a0f12e6e0d3
307668APAP 32 MG/ML Oral SuspensionSYc7a2b7b7-a2db-49e1-bef6-d3a0f12e6e0d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51316-606-16513160606161 BOTTLE in 1 CARTON (51316-606-16) / 59 mL in 1 BOTTLE1 bottle2024-03-252026-12-31NoNoHistorical