FDA.reportPublic FDA data

Childrens Acetaminophen

Product NDC
81522-285
11-digit product format
815220285
Labeler code
81522
Product ID
81522-285_0f5eba37-e7e8-4e43-9633-fbc0f8bce709
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
FSA Store Inc. (Caring Mills)
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-04-18
Marketing end
2027-03-28
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
Childrens Acetaminophen
Brand name suffix
Dye Free Grape

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN160 mg/5mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81522-285-04Childrens AcetaminophenDye Free Grape1 in 1 CARTONSUSPENSION12
81522-285-04Childrens AcetaminophenDye Free Grape118 mL in 1 BOTTLE, PLASTICSUSPENSION1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81522-285CHILDRENS ACETAMINOPHEN DYE FREE GRAPE (ACETAMINOPHEN) SUSPENSION [FSA STORE INC. (CARING MILLS)]2Current NDC, Legacy NDC, 2 package rows20240206_58dd57f1-6508-4635-b508-870218421c48.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 14 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain RelieverACETAMINOPHENHHH Pharmaceuticals0c66b05d-132d-4c79-abfe-415fd68bbb9c2026-05-06WarningsExact identifier
application number: M013
AspirinASPIRINBetter Living Brands, LLC5ebd04d8-52c7-4c72-a4c1-fc7fd488ea242026-05-06WarningsExact identifier
application number: M013
Back and Body Extra StrengthASPIRIN, CAFFEINECardinal Health 110, LLC. DBA Leader519eb216-9fa6-4d60-a2a4-3310bdb5b4ab2026-05-06WarningsExact identifier
application number: M013
AspirinASPIRINGeiss, Destin & Dunn Inc.b8f6e486-5332-4c46-ab6c-7de04c91c60b2026-05-06WarningsExact identifier
application number: M013
MAX relief junior GrapeCHILDRENS ACETAMINOPHENATLANTIC BIOLOGICALS CORP.c60494f0-5a50-41da-bcb4-88178ded54b72026-05-05WarningsExact identifier
application number: M013
equate pain relief pmACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEWALMART INC.85129749-c1a7-4c4a-933f-c3c4768e2cdd2026-05-05WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENARMY AND AIR FORCE EXCHANGE SERVICEf3feca65-adc1-469f-bef6-12c860599abe2026-05-04WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENStrategic Sourcing Services LLC4dda3534-4e83-447b-be75-33dadce06c472026-05-04WarningsExact identifier
application number: M013
Aspirin Low Dose Chewable OrangeASPIRINMajor Pharmaceuticals4ba6eed3-004a-4576-b7f7-685fae49cf6a2026-05-04WarningsExact identifier
application number: M013
Back and BodyASPIRIN, CAFFEINEKroger Company366b58db-1ac3-427b-b42a-5f56a14e298c2026-05-01WarningsExact identifier
application number: M013
Tylenol PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDESavings Distributors LLC8ed9a9f0-d37e-5c10-e053-2a95a90a559f2026-05-01WarningsExact identifier
application number: M013
Tylenol Extra StrengthACETAMINOPHENSavings Distributors LLC8ed90757-833e-f4d9-e053-2995a90a29db2026-05-01WarningsExact identifier
application number: M013
Acetaminophen , Aspirin and CaffeineACETAMINOPHEN , ASPIRIN AND CAFFEINESoftgel Healthcare Pvt Ltd4543e156-1deb-666e-e063-6394a90a719c2026-04-27WarningsExact identifier
application number: M013
Acetaminophen , Caffeine and pyrilamine maleateACETAMINOPHEN , CAFFEINE AND PYRILAMINE MALEATESoftgel Healthcare Pvt Ltd45478958-ad86-4d87-e063-6394a90a3c452026-04-27WarningsExact identifier
application number: M013
Medique at Home AspirinASPIRINSportpharm LLC0f2aa75e-534f-478b-811e-fb492b7af9bb2026-04-24WarningsExact identifier
application number: M013
Medique at Home APAP Extra StrengthACETAMINOPHEN 500 MGSportpharm LLCcc280926-ad94-4017-a04a-b4315807eacb2026-04-24WarningsExact identifier
application number: M013
AspirinASPIRINHealth Pharma USA LLC503868bb-48e0-b718-e063-6394a90a9c5b2026-04-24WarningsExact identifier
application number: M013
BC CHERRYASPIRIN AND CAFFEINEMedtech Products Inc.c5fa6660-a549-49ff-ac2b-5799afa22ec52026-04-24WarningsExact identifier
application number: M013
Doans Maximum StrengthMAGNESIUM SALICYLATEDr. Reddy's Laboratories Inc.c906df41-bb45-03ea-b1a8-2b9816d55c972026-04-24WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENTIME CAP LABORATORIES, INC.48912649-9fa1-a11f-e063-6294a90a8a722026-04-23WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN58dd57f1-6508-4635-b508-870218421c482
307668acetaminophen 32 MG/ML Oral SuspensionSCD58dd57f1-6508-4635-b508-870218421c482
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY58dd57f1-6508-4635-b508-870218421c482
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY58dd57f1-6508-4635-b508-870218421c482
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY58dd57f1-6508-4635-b508-870218421c482
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY58dd57f1-6508-4635-b508-870218421c482
307668APAP 32 MG/ML Oral SuspensionSY58dd57f1-6508-4635-b508-870218421c482

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
81522-285-04815220285041 BOTTLE, PLASTIC in 1 CARTON (81522-285-04) / 118 mL in 1 BOTTLE, PLASTIC2022-04-182027-03-28NoNoCurrent