FDA.reportPublic FDA data

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 12 of 83 · 1,657 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLFamily Dollar (FAMILY WELLNESS)7a98d4d9-54e2-45c1-a76a-7f1907566e952026-06-01WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENTIME CAP LABORATORIES, INC.58840cf4-aceb-c7cf-e063-6294a90a5ff42026-06-01WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENCVS Pharmacy832acd72-1dda-4490-978f-5f31748942df2026-06-01WarningsExact identifier
application number: M013
Acetaminophen PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEMajor Pharmaceuticals786dbcd5-f5c2-4491-e053-2991aa0a34372026-05-29WarningsExact identifier
application number: M013
Back and Body Extra StrengthASPIRIN, CAFFEINEMeijer Distribution Ince513f2d9-d591-4790-a117-6176ce2279dc2026-05-29WarningsExact identifier
application number: M013
Chewable Acetaminophen ChildrensACETAMINOPHENCardinal Health 110, LLC. DBA Leader5460a4b7-5da3-4fc2-a565-0b0dd11bbf442026-05-29WarningsExact identifier
application number: M013
Extra Strength Mini Softgels Pain RelieverACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDf55d3663-7007-41cd-ae2d-5aca6311be812026-05-28WarningsExact identifier
application number: M013
Genexa Kids Pain and FeverACETAMINOPHENGenexa Inc.5130c695-a80e-2dd3-e063-6294a90a404f2026-05-28WarningsExact identifier
application number: M013
TYLENOL Regular StrengthACETAMINOPHENKenvue Brands LLC1622f694-4d63-4c56-8737-fae31f0ecfb72026-05-27WarningsExact identifier
application number: M013
INFANTS Pain and FeverACETAMINOPHENAurohealth LLC257436e1-e0f3-4a87-bffe-4f176b836caf2026-05-27WarningsExact identifier
application number: M013
Infants Pain and FeverACETAMINOPHENAurohealth LLC6509a545-0036-460a-8f0d-b31caae178552026-05-27WarningsExact identifier
application number: M013
Alka-Seltzer OriginalANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATESelect Consumer Group3ca80d74-1e8b-49d9-e063-6394a90a43122026-05-24WarningsExact identifier
application number: M013
Pain and Fever Chewables ChildrensACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDbad8ac0a-518d-4639-9b92-a39e0d4372382026-05-22WarningsExact identifier
application number: M013
ACETAMINOPHEN 500 MGACETAMINOPHENA-S Medication Solutions92559d65-f5e2-4054-9763-b9c560452dab2026-05-22WarningsExact identifier
application number: M013
Acetaminophen PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEGrocery Outlet, Inc.441d2629-3fff-0bf1-e063-6394a90aa9b62026-05-21WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENGrocery Outlet, Inc.441d1bde-d677-fab7-e063-6394a90aaad42026-05-21WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENGrocery Outlet, Inc.441d3a39-cc55-3c7c-e063-6394a90ad7a72026-05-21WarningsExact identifier
application number: M013
INFANTS Pain and FeverACETAMINOPHENAurohealth LLCb3f57af5-661f-4534-9eed-76e431f338db2026-05-20WarningsExact identifier
application number: M013
Good Sense aspirinASPIRINL. Perrigo Companye150dd59-8db8-449f-9c9a-1aa6deb3be2e2026-05-20WarningsExact identifier
application number: M013
Infants Pain and FeverACETAMINOPHENAurohealth LLCe837538d-0515-4f99-b04c-fda63b28777e2026-05-20WarningsExact 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