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 66 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
topcare infants pain and feverACETAMINOPHENTopco Associates LLCa1145ac3-3e55-4bd5-a53e-6cf869add9a12024-07-02WarningsExact identifier
application number: M013
Drug Mart Effervescent Pain ReliefASPIRINDiscount Drug Mart Inc1c35f394-a221-6531-e063-6394a90acb8a2024-07-01WarningsExact identifier
application number: M013
AspirinASPIRINWildman Business Groupcdbfcf14-8685-40a9-9778-a3b4329dc1ad2024-07-01WarningsExact identifier
application number: M013
Back Pain Relief Extra Strength DoansMAGNESIUM SALICYLATEWildman Business Group2e17664f-a83f-48d1-8b2b-37f41eea65b62024-07-01WarningsExact identifier
application number: M013
Meijer Effervescent Pain ReliefASPIRINMeijer Distribution Inc17553911-e0fc-e355-e063-6394a90af7b82024-06-28WarningsExact identifier
application number: M013
leader childrens pain and feverACETAMINOPHENCardinal Health 110, LLC. dba Leader4fb4f4b2-c238-4933-b874-08def3b34a282024-06-26WarningsExact identifier
application number: M013
good neighbor pharmacy pain and fever childrensACETAMINOPHENAmerisource Bergenca0833ef-837b-47dc-8676-e016af96622c2024-06-26WarningsExact identifier
application number: M013
leader childrens pain and feverACETAMINOPHENCardinal Health 110, LLC. dba Leader4a030c3e-8104-4a0a-98c5-6ab469451f202024-06-26WarningsExact identifier
application number: M013
Childrens AcetaminophenACETAMINOPHENPadagis Israel Pharmaceuticals Ltda426dd82-b2d6-405e-b0af-cfb1310a6e192024-06-26WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWALMART INC. (see also Equate)7d86a03f-74f4-4b24-b6a6-8747acfe905e2024-06-26WarningsExact identifier
application number: M013
leader childrens pain and feverACETAMINOPHENCardinal Health 110, LLC. dba Leader5bcc5da9-7e64-4308-a5be-2f47a8ca774d2024-06-25WarningsExact identifier
application number: M013
Codeine-GuaifenesinCODEINE PHOSPHATE AND GUAIFENESINNuCare Pharmaceuticals,Inc.9e691264-d48a-6b48-e053-2995a90a93522024-06-20WarningsExact identifier
application number: M013
AspirinREGULAR STRENGTH ENTERIC COATED ASPIRINNuCare Pharmceuticals,Inc.a0705f4f-55cb-214a-e053-2995a90aa6802024-06-20WarningsExact identifier
application number: M013
Extra Strength Pain RelieverACETAMINOPHEN 500 MGLil' Drug Store Products, Inc.ee8e0e79-4da4-101f-e053-2a95a90a30a42024-06-19WarningsExact identifier
application number: M013
Extra Strength Headache ReliefACETAMINOPHEN, ASPIRIN, AND CAFFEINELil' Drug Store Products, Inc.b3a06e4b-0b31-4e2a-8dd1-9de85760477b2024-06-19WarningsExact identifier
application number: M013
pain reliefACETAMINOPHENMeijer Distribution Inc43c3fe72-a4ef-48a6-bc22-a644919c0c5c2024-06-17WarningsExact identifier
application number: M013
Aspirin Regular StrengthASPIRINRETAIL BUSINESS SERVICES , LLC.093182a6-3ed8-5a3f-e063-6294a90a354a2024-06-14WarningsExact identifier
application number: M013
ACETAMINOPHEN PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.093199be-e92a-6f60-e063-6294a90a85332024-06-14WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENRETAIL BUSINESS SERVICES , LLC.09315a3d-bb2d-4f06-e063-6294a90a3bd32024-06-14WarningsExact identifier
application number: M013
Pain Relief Regular StrengthACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION INC613bc633-0426-41a7-aea9-9ff56311b6072024-06-13WarningsExact 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