Acetaminophen

Product NDC
69729-028
11-digit product format
697290028
Labeler code
69729
Product ID
69729-028_5c3f9409-c92e-78dd-e063-6294a90aa7d4
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
OPMX LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-02-01
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
Acetaminophen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN160 mg/5mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69729-028-02Acetaminophen60 mL in 1 BOTTLESUSPENSION606

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69729-028ACETAMINOPHEN SUSPENSION TEMP X (ACETAMINOPHEN) SUSPENSION MEJORALITO (ACETAMINOPHEN) SUSPENSION [OPMX LLC]5Current NDC, Legacy NDC, 1 package rows20230609_5b8a92c9-47c0-4438-a49d-b3878f7afd73.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 63 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
good sense childrens pain and feverACETAMINOPHENL. Perrigo Company61a88a72-cf4f-4ec9-bc24-e110adfb98ba2024-09-19WarningsExact identifier
application number: M013
childrens pain and feverACETAMINOPHENWalgreen Company550c4229-c3a3-442c-a9ed-2d04cd4bad512024-09-14WarningsExact identifier
application number: M013
Rugby AspirinASPIRINRugby Laboratories15922349-2825-45d3-95ff-c5a2879ec2252024-09-12WarningsExact identifier
application number: M013
rexall pain reliefACETAMINOPHENDolgencorp, LLC9783cf37-3a2b-4ca1-b4eb-6d6ba047a3252024-09-12WarningsExact identifier
application number: M013
leader aspirinASPIRINCardinal Health 110, LLC. dba Leaderb8cc9f78-a292-40eb-819d-bd80a552628f2024-09-11WarningsExact identifier
application number: M013
pain reliefACETAMINOPHENH E B3258ef39-c36e-4a97-8631-89b8d4caf0582024-09-11WarningsExact identifier
application number: M013
Acetaminophen and Diphenhydramine hydrochlorideACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEKROGER COMPANYb9b86755-63ad-e25a-e053-2995a90ad7472024-09-10WarningsExact identifier
application number: M013
aspirinASPIRINPublix Super Markets Inc88b0d897-b93f-42c3-88d0-784dd6c555e42024-09-10WarningsExact identifier
application number: M013
good neighbor pharmacy aspirinASPIRINAmerisource Bergen820ceaee-2b49-4204-8ebb-d683d9b62e142024-09-10WarningsExact identifier
application number: M013
Parents Choice Infants Pain and FeverACETAMINOPHENWal-Mart Stores Inc30a51b90-a565-4e38-82ee-b5af297629772024-09-10WarningsExact identifier
application number: M013
equate aspirin chewableASPIRINWal-Mart Stores Inc9147c0ce-fcdb-457c-b9f5-e4edd66e91d02024-09-10WarningsExact identifier
application number: M013
signature care infants pain reliefACETAMINOPHENSafeway236df05a-cf11-42f3-a347-b54f5113680c2024-09-10WarningsExact identifier
application number: M013
pain reliefACETAMINOPHENMeijer Distribution Incd2759fa6-59cd-417e-8761-d2b129aad8b82024-09-09WarningsExact identifier
application number: M013
M-PAPACETAMINOPHENBryant Ranch Prepackd344479b-80c1-4592-acc8-3f12690c839c2024-09-06WarningsExact identifier
application number: M013
signature care childrens pain reliefACETAMINOPHENSafewayfccb5aca-5707-491f-beb4-08f5689191692024-09-06WarningsExact identifier
application number: M013
HEADACHE RELIEFACETAMINOPHEN-ASPIRIN-CAFFEINETARGET CORPORATION8e953cef-135e-f1aa-e053-2995a90aaa8b2024-09-05WarningsExact identifier
application number: M013
AspirinASPIRINCVS Pharmacy5cf74d72-c818-400a-9279-87e209efeb152024-09-05WarningsExact identifier
application number: M013
ASPIRNASPIRINHF Acquisition Co LLC, DBA HealthFirst21524b42-f8fd-673c-e063-6294a90a22e82024-09-04WarningsExact identifier
application number: M013
Topcare AspirinASPIRINTopco Associates LLC6615bf85-1f79-4d21-91f9-4248c3cf9b382024-09-04WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENTARGET CORPORATION80da2582-1a20-e111-e053-2991aa0acf322024-09-03WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSN5b8a92c9-47c0-4438-a49d-b3878f7afd736
307668acetaminophen 32 MG/ML Oral SuspensionSCD5b8a92c9-47c0-4438-a49d-b3878f7afd736
307668acetaminophen 160 MG per 5 ML Oral SuspensionSY5b8a92c9-47c0-4438-a49d-b3878f7afd736
307668acetaminophen 320 MG per 10 ML Oral SuspensionSY5b8a92c9-47c0-4438-a49d-b3878f7afd736
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSY5b8a92c9-47c0-4438-a49d-b3878f7afd736
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSY5b8a92c9-47c0-4438-a49d-b3878f7afd736
307668APAP 32 MG/ML Oral SuspensionSY5b8a92c9-47c0-4438-a49d-b3878f7afd736

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69729-028-026972900280260 mL in 1 BOTTLE (69729-028-02) 60 ml2021-02-010000-00-00NoNoCurrent