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 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 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