FDA.reportPublic FDA data

Acetaminophen

Product NDC
55154-9449
11-digit product format
551549449
Labeler code
55154
Product ID
55154-9449_2990683a-fa4c-40cc-ab3f-6162a56509e2
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SOLUTION
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2007-08-01
Substance
ACETAMINOPHEN
Active strength
650 mg/20.3mL
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
ACETAMINOPHEN650 mg/20.3mL

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
307675Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e13656eb-513e-411e-bdae-35ff1ba7cfc1Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-9449-5Acetaminophen20.3 mL in 1 CUP, UNIT-DOSESOLUTION20.39
55154-9449-5Acetaminophen5 in 1 BAGSOLUTION59

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-9449ACETAMINOPHEN SOLUTION [CARDINAL HEALTH 107, LLC]8Current NDC, Legacy NDC, 2 package rows20250312_e13656eb-513e-411e-bdae-35ff1ba7cfc1.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 35 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Goodys Cool Orange HeadacheACETAMINOPHEN AND ASPIRIN AND CAFFEINEMedtech Products Inc.31212c97-9975-427e-bc3d-f7125f30299a2025-10-23WarningsExact identifier
application number: M013
BC ArthritisASPIRIN AND CAFFEINEMedtech Products Inc.3a85be2d-6548-4de5-8109-60e1ca2bfca32025-10-23WarningsExact identifier
application number: M013
Goodys Extra StrengthACETAMINOPHEN, ASPIRIN, AND CAFFEINEMedtech Products Inc.d4325b17-23bc-44ac-868d-bb0886853a732025-10-23WarningsExact identifier
application number: M013
BCASPIRIN AND CAFFEINEMedtech Products Inc.226173d4-b6d5-4fe6-b24e-1cc5d1b31c882025-10-23WarningsExact identifier
application number: M013
BC MAXASPIRIN, ACETAMINOPHEN, CAFFEINEMedtech Products Inc.1e2a07ab-23e6-49b4-a676-212dc6880f142025-10-23WarningsExact identifier
application number: M013
Ecotrin Regular StrengthASPIRINMedtech Products Inc.36cb530b-25b2-4f62-a25d-aa04360815a82025-10-23WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENTOPCO ASSOCIATES LLCbbc367cc-6c79-498e-8fca-1347e6ea1a8c2025-10-22WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENRugby Laboratoriesb16ed4ef-689c-4df2-ab6c-207aa8b9925d2025-10-22WarningsExact identifier
application number: M013
Tension Headache ReliefACETAMINOPHEN, CAFFEINETIME CAP LABS INC05364eb4-07a1-a4d9-e063-6294a90a47e52025-10-21WarningsExact identifier
application number: M013
Acetaminophen, Aspirin, CaffeineACETAMINOPHEN, ASPIRIN, CAFFEINECVS Pharmacy, Inc.6deb854f-863e-24ad-e053-2991aa0afb172025-10-21WarningsExact identifier
application number: M013
BackAidACETAMINOPHEN, CAFFEINEKobayashi Healthcare International, Inc.25db6bb5-96b6-4be1-e063-6294a90a23002025-10-21WarningsExact identifier
application number: M013
M-PAPACETAMINOPHENMethod Pharmaceuticals, LLC1539dc44-15a0-153b-e063-6294a90a9d452025-10-21WarningsExact identifier
application number: M013
M-PAPACETAMINOPHENMethod Pharmaceuticals, LLC3d1bb61c-15db-4eba-aba9-cfbcbc7b30e02025-10-21WarningsExact identifier
application number: M013
Walgreens Antacid Pain Relief Extra StrengthASPIRIN, CITRIC ACID, SODIUM BICARBONATEWalgreensb60df498-07db-500b-e053-2a95a90aff6a2025-10-17WarningsExact identifier
application number: M013
Equate Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEWalmart6271b34b-55a0-40a8-e053-2a91aa0acb222025-10-17Warnings, Adverse reactionsExact identifier
application number: M013
Xesso NeoBENZOCAINEPREMIUM NATURAL COSMETICS INC163f32cd-4e51-950a-e063-6394a90a48162025-10-17WarningsExact identifier
application number: M013
Menstrual Complete Maximum StrengthACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATECHAIN DRUG MARKETING ASSOCIATION INC913d8bdb-7644-464c-b9a6-55387ff120592025-10-17WarningsExact identifier
application number: M013
Alka-Seltzer Hangover ReliefANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATEBayer HealthCare LLC.dc235b06-999e-221d-e053-2a95a90a0ce12025-10-16WarningsExact identifier
application number: M013
Aspirin 81mgASPIRIN ENTERIC COATED TABLETS 81MGVITANE PHARMACEUTICALS, INC41386de5-5857-efab-e063-6294a90afd9c2025-10-15WarningsExact identifier
application number: M013
Aspirin 81mgASPIRIN ENTERIC COATED TABLETS 81MGVITANE PHARMACEUTICALS, INC4138d4c0-baa5-1f20-e063-6394a90a788f2025-10-15WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307675acetaminophen 160 MG in 5 mL Oral SolutionPSNe13656eb-513e-411e-bdae-35ff1ba7cfc19
307675acetaminophen 32 MG/ML Oral SolutionSCDe13656eb-513e-411e-bdae-35ff1ba7cfc19
307675acetaminophen 160 MG per 5 ML Oral SolutionSYe13656eb-513e-411e-bdae-35ff1ba7cfc19
307675acetaminophen 325 MG per 10.15 ML Oral SolutionSYe13656eb-513e-411e-bdae-35ff1ba7cfc19
307675acetaminophen 650 MG per 20.3 ML Oral SolutionSYe13656eb-513e-411e-bdae-35ff1ba7cfc19
307675acetaminophen 80 MG per 2.5 ML Oral SolutionSYe13656eb-513e-411e-bdae-35ff1ba7cfc19
307675APAP 32 MG/ML Oral SolutionSYe13656eb-513e-411e-bdae-35ff1ba7cfc19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55154-9449-5551549449055 CUP, UNIT-DOSE in 1 BAG (55154-9449-5) / 20.3 mL in 1 CUP, UNIT-DOSE2007-08-010000-00-00NoNoCurrent