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 78 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tri-Buffered AspirinASPIRINProficient Rx LP640c3311-2abf-40b2-82b9-9fe4d8c1cf1d2023-10-01WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCVS PHARMACY, INC852e70e2-7279-6f33-e053-2991aa0a86762023-08-28WarningsExact identifier
application number: M013
Children Pain ReliefCHILDREN PAIN RELIEFAllegiant Health44c90cbe-8ece-4dd8-9ea5-7f8d6f4c00962023-07-17WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINBetter Living Brands LLC4a76e898-3204-4f77-bc67-c19f5fe829f32023-07-05WarningsExact identifier
application number: M013
Aspirin Enteric CoatedASPIRIN 81 MGLodaat LLC04017bc9-602a-4204-96a9-b7f9713155f62023-01-31WarningsExact identifier
application number: M013
Aspirin 325 mgASPIRINWALGREENSd71a22e8-9e39-a672-e053-2a95a90a14032022-07-08WarningsExact identifier
application number: M013
Pain Relief Extra StrengthPAIN RELIEFAllegiant Healthd41d2319-8eed-4df9-813c-313497ceb8b42021-11-23WarningsExact identifier
application number: M013
Pain Relief PM Extra StrengthPAIN RELIEF PMAllegiant Health4c9969be-a01f-4ca4-800a-e404229ce28b2021-11-23WarningsExact identifier
application number: M013
Tension Headache ReliefTENSION HEADACHE RELIEFAllegiant Health9d348550-060b-410f-8c1e-8f43d00b860e2021-11-22WarningsExact identifier
application number: M013
Aspirin 81mg Enteric coated Low Strength Aspirin RegimenASPIRINAllegiant Health847fd2f8-2e32-4ef2-a793-b902045110f12021-11-19WarningsExact identifier
application number: M013
Aspirin 81mg Enteric coated Delayed ReleaseASPIRINAllegiant Healthd6c7c8c9-b997-4acc-a066-133bfb1239cb2021-11-02WarningsExact identifier
application number: M013
Aspirin 81mg Enteric coated Delayed ReleaseASPIRINDr. Wayne'seacbdf9e-5642-4986-a03c-b0812d28265d2021-11-02WarningsExact identifier
application number: M013
Aspirin 81mg Enteric coated Low Strength Aspirin RegimenASPIRINAllegiant Healthd9abe780-7e58-43d8-848f-c6c8893aea2e2021-10-14WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHEN 500MGAllegiant Health0f72be92-fac0-4be4-87a3-3f20f0f01db52021-05-17WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENWestminster Pharmaceuticals, LLCace5ebac-ec11-4c26-b1e3-954b450ee6712021-05-04WarningsExact identifier
application number: M013
Aspirin Enteric CoatedASPIRIN 81 MGAllegiant Health8cacf02c-9925-40d4-92bc-78788aa0681a2020-11-11WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHEN 500 MGAllegiant Health8e60b78e-ef3c-4d44-b8d4-37cb8608a5c72020-03-13WarningsExact identifier
application number: M013
Acetaminophen 500mg ESACETAMINOPHEN 500MGAllegiant Health91acc132-01b6-467b-9af5-70f4dc93e0872019-01-08WarningsExact identifier
application number: M013
Acetaminophen 325mg RSACETAMINOPHEN 325MGAllegiant Health61c6d281-e59b-4277-bbce-f71c12c2a56d2019-01-07WarningsExact identifier
application number: M013
Cold Multi-SymptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAllegiant Health9a4c0c43-a71a-4e22-a3d5-9eb9622689a22019-01-02WarningsExact 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