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 26 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CareALL Acetaminophen Extra StrengthACETAMINOPHENNew World Imports, Incf818417e-0b31-4fe7-8313-4160a00b248a2025-12-22WarningsExact identifier
application number: M013
CareALL AcetaminophenACETAMINOPHENNew World Imports, Incc4f82ed8-b82c-47bb-9ab9-108a13d29cf72025-12-22WarningsExact identifier
application number: M013
CareALL Acetaminophen Extra StrengthACETAMINOPHENNew World Imports, Inc5103450a-3095-49cc-9823-4fb4c1d258ff2025-12-22WarningsExact identifier
application number: M013
CAREALL Non-Aspirin PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLNew World Imports, Inc499b2bf8-72fb-4500-b16e-517cab09a8ae2025-12-22WarningsExact identifier
application number: M013
CAREALL Pain Relief PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLNew World Imports, Inc933154b9-c9d6-4260-8775-1c83631c74e42025-12-22WarningsExact identifier
application number: M013
CAREALL Pain Relief PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLNew World Imports, Incc93aa5e4-3994-439f-8f14-4e81773ed4e22025-12-22WarningsExact identifier
application number: M013
Acetaminophen Diphenhydramine HClACETAMINOPHEN DIPHENHYDRAMINE HCLGranules USA, Inc.8c9f68e3-fedc-6457-e053-2995a90a045a2025-12-22WarningsExact identifier
application number: M013
AspirinASPIRINL.N.K. International, Inc.35005045-57b2-4ffe-ab70-22d570c1b1612025-12-22WarningsExact identifier
application number: M013
Tension Headache ReliefACETAMINOPHEN, CAFFEINENUVICARE LLCea4e50e9-2c4d-4e58-b2cb-ab23e91fd50e2025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENWalmart175495fd-c561-f813-e063-6294a90aac802025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENWALMART INC21b22e9f-b6d1-1819-e063-6294a90ae09c2025-12-19WarningsExact identifier
application number: M013
Acetaminophen and Diphenhydramine HCLACETAMINOPHEN AND DIPHENHYDRAMINE HCLSAFEWAYf18c1aa2-5f8b-5458-e053-2995a90ab9472025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENMeijer181b3148-fa33-c650-e063-6294a90a0de62025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENTOPCO ASSOCIATES LLC1a00a49e-f9ff-b928-e063-6394a90a4cb52025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPUBLIX SUPERMARKETS, INC08f57305-0c4b-96b1-e063-6394a90a77df2025-12-19WarningsExact identifier
application number: M013
Acetaminophen and Diphenhydramine HCLACETAMINOPHEN AND DIPHENHYDRAMINE HCLPUBLIX SUPERMARKETS, INC08f549cf-042a-7bf2-e063-6394a90a83ef2025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENWALGREEN CO.b8a855ae-c0a3-0b05-e053-2a95a90ac8a82025-12-19WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENMarc Glassman, Inc.f708e1ec-cf2a-4e2b-851f-f6b703f359b22025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENWALGREEN CO.b375de90-25c7-aa55-e053-2995a90a3cf82025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENTARGET CORPORATIONe64a3c32-5466-0662-e053-2a95a90ae9632025-12-19WarningsExact 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