infants pain fever

Product NDC
59640-590
11-digit product format
596400590
Labeler code
59640
Product ID
59640-590_d3b4df1a-2b45-4922-9f16-753bfb13167d
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
H E B
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-22
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
infants pain fever
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN160 mg/5mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59640-590-16infants pain fever59 mL in 1 BOTTLESUSPENSION592
59640-590-16infants pain fever1 in 1 CARTONSUSPENSION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59640-590INFANTS PAIN FEVER (ACETAMINOPHEN) SUSPENSION [H E B]2Current NDC, 2 package rows20240802_ab8ecc76-9621-4acc-b59b-fcf6cb2e52ef.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 64 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tylenol PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEJones Healthcare Group - Packaging Services, Inc639f4e01-9723-a619-e053-2991aa0a549a2024-08-27WarningsExact identifier
application number: M013
Extra Strength Acetaminohpen Adult Rapid Burst CherryACETAMINOPHENMajor Pharmaceuticals9e7543d9-6249-45b5-b67d-c1b439423b9c2024-08-27WarningsExact identifier
application number: M013
aspirinASPIRINMajor Pharmaceuticals58684138-04d1-44a4-bc52-c5b85d93d7a62024-08-23WarningsExact identifier
application number: M013
Up and Up childrens acetaminophenACETAMINOPHENTarget Corporation9c3ba4dd-f51b-46ce-91b8-8b617c7b78da2024-08-23WarningsExact identifier
application number: M013
CVS Effervescent Pain RelieverASPIRINCVS PHARMACY0761147f-1337-606e-e063-6394a90abd5d2024-08-22WarningsExact identifier
application number: M013
pain relieverACETAMINOPHENWalgreen Company8255900a-2d58-4261-8df7-f283198835702024-08-21WarningsExact identifier
application number: M013
Pain and FeverACETAMINOPHENH E B86a072a9-c3b8-47f7-8598-d66e3d30e7622024-08-21WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENKroger Companyd965eba0-b268-41b2-8e02-5f6d769a44d72024-08-18WarningsExact identifier
application number: M013
equate pain and fever childrensACETAMINOPHENWal-Mart Stores Incea68d735-c677-4280-a3a3-ae3eb5ff74622024-08-17WarningsExact identifier
application number: M013
childrens pain and feverACETAMINOPHENCVS Pharmacyfac408f0-ebb6-4c72-88ee-2ba85867859c2024-08-16WarningsExact identifier
application number: M013
Regular Strength Pain ReliefACETAMINOPHENBryant Ranch Prepack3f0c32b1-2c54-4ca3-9759-9e5dd9d7ad242024-08-14WarningsExact identifier
application number: M013
Quality Choice Effervescent Antacid and Pain Relief - Extra StrengthASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATEChain Drug Marketing Association1f926637-a61c-8eb7-e063-6394a90a65022024-08-13WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharma6ec12573-03d6-40c1-9945-d345b401e0622024-08-12WarningsExact identifier
application number: M013
CareOne Infants AcetaminophenACETAMINOPHENAmerican Sales Companyeacee273-abd7-4ea4-bcaa-7f74abcc9feb2024-08-07WarningsExact identifier
application number: M013
infants pain and feverACETAMINOPHENKroger Company7dbe284a-c0d5-4ac4-8445-611610f3c0fb2024-08-02WarningsExact identifier
application number: M013
Dollar General Effervescent Pain RelieverASPIRINDolgencorp, Inc1deab362-a325-3a00-e063-6294a90a9acd2024-08-01WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENFSA STORE INC.1cd6a3e6-1376-0b7b-e063-6394a90af3d12024-07-30WarningsExact identifier
application number: M013
pain relief pm extra strengthACETAMINOPHEN, DIPHENHYDRAMINE HCLPublix Super Markets Inc42d271b7-b45f-4497-8de2-4e05b4bebfa92024-07-17WarningsExact identifier
application number: M013
basic care acetaminophen pmACETAMINOPHEN, DIPHENHYDRAMINE HCLAmazon.com Services LLC64a0084a-e29e-4c1a-8704-13a3e1238f762024-07-17WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINWalmart Inc.152c013a-c81c-f8f9-e063-6294a90a9f232024-07-15WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNab8ecc76-9621-4acc-b59b-fcf6cb2e52ef2
307668acetaminophen 32 MG/ML Oral SuspensionSCDab8ecc76-9621-4acc-b59b-fcf6cb2e52ef2
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYab8ecc76-9621-4acc-b59b-fcf6cb2e52ef2
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYab8ecc76-9621-4acc-b59b-fcf6cb2e52ef2
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYab8ecc76-9621-4acc-b59b-fcf6cb2e52ef2
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYab8ecc76-9621-4acc-b59b-fcf6cb2e52ef2
307668APAP 32 MG/ML Oral SuspensionSYab8ecc76-9621-4acc-b59b-fcf6cb2e52ef2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59640-590-16596400590161 BOTTLE in 1 CARTON (59640-590-16) / 59 mL in 1 BOTTLE1 bottle2024-07-22NoNoCurrent