Childrens Acetaminophen

Product NDC
55154-5787
11-digit product format
551545787
Labeler code
55154
Product ID
55154-5787_921b627e-0a64-40f9-adab-b788a6e119f6
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2007-09-17
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
Childrens Acetaminophen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN160 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
307668Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7562f4e4-54fa-488c-a199-48ad2632e2a1Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-5787-5Childrens Acetaminophen5 mL in 1 CUP, UNIT-DOSESUSPENSION59
55154-5787-5Childrens Acetaminophen5 in 1 BAGSUSPENSION59

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-5787CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [CARDINAL HEALTH 107, LLC]7Current NDC, Legacy NDC, 2 package rows20240109_7562f4e4-54fa-488c-a199-48ad2632e2a1.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 43 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EXTRA PAIN RELIEFACETAMINOPHEN, ASPIRIN AND CAFFEINETIME CAP LABS59482917-f80b-4bed-9218-068b35366eb32025-07-11WarningsExact identifier
application number: M013
Up and Up Childrens acetaminophenACETAMINOPHENTarget Corporation25a476a4-9969-49b3-94bf-b076bada4cea2025-07-10WarningsExact identifier
application number: M013
Tylenol Extra Strength CapletACETAMINOPHENJones Healthcare Group - Packaging Services, Incfba711c1-4e69-49b0-8994-97c455aebcb22025-07-09WarningsExact identifier
application number: M013
good sense pain reliefACETAMINOPHENL. Perrigo Companyaf7ae548-38ad-41d5-b1cb-761cd2e386d32025-07-08WarningsExact identifier
application number: M013
topcare pain reliefACETAMINOPHENTopco Associates LLC6aca88df-d3b5-4a60-b23b-1e66dc41ee7b2025-07-08WarningsExact identifier
application number: M013
equate childrens pain and feverACETAMINOPHENWal-Mart Stores Incf15037a5-4e43-4dd6-93b8-b37a1cc22cd62025-07-07WarningsExact identifier
application number: M013
Childrens Acetaminophen Oral Liquid Grape FlavorACETAMINOPHENAARNA USA INC.39347f5d-2d3c-0c23-e063-6294a90a3a462025-07-05WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENMeijer Distribution Incbe841460-98b4-4448-a494-09ff161fd1312025-07-02WarningsExact identifier
application number: M013
Adult Low Dose AspirinASPIRINAdvanced Rx LLCad0d6a5c-eee9-406c-8d7f-1df9b45f53402025-07-02WarningsExact identifier
application number: M013
EXTRA STRENGHT HEADACHE RELIEFACETAMINOPHEN, ASPIRIN, CAFFEINELil' Drug Store Products, Inc.ec04eb5d-96c0-ddb4-e053-2a95a90a4a922025-07-02WarningsExact identifier
application number: M013
Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo packDEXTROMETHORPHAN HBR, GUAIFENESIN, ACETAMINOPHEN, DOXYLAMINE SUCCINATEGenexa Inc.18835205-a9e3-15c2-e063-6394a90a81072025-07-02WarningsExact identifier
application number: M013
FeverAllACETAMINOPHENSun Pharmaceutical Industries, Inc.8970b91b-5f3c-4764-9e23-25dcb398d0a72025-07-02WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENMeijer Distribution Inc11c9712d-c3b2-49cd-9c2b-0f57190c954e2025-07-02WarningsExact identifier
application number: M013
Aspirin Regular StrengthASPIRINUnited Natural Foods, Inc. dba UNFI979973c1-661a-4384-8b92-fd901ebde5582025-07-01WarningsExact identifier
application number: M013
Pain and Fever ChildrensACETAMINOPHENCVS Pharmacyf6bbce1c-9790-4ca4-847f-579c594ffe0b2025-07-01WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWALGREENS07d2e322-2465-79e5-e063-6294a90a5ea42025-06-30WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDISCOUNT DRUG MART66c0cf26-357b-4722-9100-3b86d507a8cd2025-06-30WarningsExact identifier
application number: M013
ALLERGYDIPHENHYDRAMINE HYDROCHLORIDEKroger Companybc019c9e-8fac-5fd3-e053-2a95a90a7ccd2025-06-25WarningsExact identifier
application number: M013
ACETAMINOPHEN Extra StrengthACETAMINOPHENTIME CAP LABS INCfd24d0e0-4f36-42d3-9149-2fb9576903052025-06-25WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINATLANTIC BIOLOGICALS CORP.024c5054-959f-4ea5-a71f-c0e16cc4b90c2025-06-24WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN7562f4e4-54fa-488c-a199-48ad2632e2a19
307668acetaminophen 32 MG/ML Oral SuspensionSCD7562f4e4-54fa-488c-a199-48ad2632e2a19
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY7562f4e4-54fa-488c-a199-48ad2632e2a19
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY7562f4e4-54fa-488c-a199-48ad2632e2a19
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY7562f4e4-54fa-488c-a199-48ad2632e2a19
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY7562f4e4-54fa-488c-a199-48ad2632e2a19
307668APAP 32 MG/ML Oral SuspensionSY7562f4e4-54fa-488c-a199-48ad2632e2a19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55154-5787-5551545787055 CUP, UNIT-DOSE in 1 BAG (55154-5787-5) / 5 mL in 1 CUP, UNIT-DOSE2007-09-170000-00-00NoNoCurrent