FDA.reportPublic FDA data

Acetaminophen

Product NDC
0121-0941
11-digit product format
001210941
Labeler code
0121
Product ID
0121-0941_bbd6f65a-a6ec-4c17-935c-ed743c45e2c8
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SUSPENSION
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-09-03
Substance
ACETAMINOPHEN
Active strength
160 mg/5mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
2026-12-31

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
caf5daea-409e-5dd2-e053-2995a90acb12Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-0941-00Acetaminophen10 in 1 TRAYSUSPENSION105
0121-0941-00Acetaminophen10 in 1 CASESUSPENSION105
0121-0941-05Acetaminophen5 mL in 1 CUP, UNIT-DOSESUSPENSION55
0121-0941-94Acetaminophen3 in 1 CASESUSPENSION35
0121-0941-94Acetaminophen10 in 1 TRAYSUSPENSION105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0941ACETAMINOPHEN SUSPENSION [PAI HOLDINGS, LLC DBA PAI PHARMA]4Current NDC, Legacy NDC, 5 package rows20241114_caf5daea-409e-5dd2-e053-2995a90acb12.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 27 of 79 · 1,561 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENFAMILY DOLLARf8383108-0970-9f1e-e053-6294a90ad38f2025-12-19WarningsExact identifier
application number: M013
ACETAMINOPHEN 500 MGACETAMINOPHENNUVICARE LLC591ee107-e953-4982-b75f-13a0afd7c4ae2025-12-19WarningsExact identifier
application number: M013
Nuvicare Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINENUVICARE LLC3ede0fb6-c089-4253-9878-2b01c39e9c872025-12-19WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINNUVICARE LLC3a4aa3c7-b726-4303-8803-74196fa5637a2025-12-19WarningsExact identifier
application number: M013
ACETAMINOPHEN 500 MGACETAMINOPHENNUVICARE LLC95edf7bd-b6a7-4be5-9ad7-8748e7c2d06e2025-12-19WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN, DIPHENHYDRAMINENUVICARE LLC32a5611b-9bf6-4850-a7ff-fa240da04f452025-12-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENBETTER LIVING BRANDS LLC.ac0e96d0-746e-fb42-e053-2a95a90a19572025-12-18WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENBETTER LIVING BRANDS LLC.ac0e5dc0-96eb-47b2-e053-2995a90add0e2025-12-18WarningsExact identifier
application number: M013
Acetaminophen Diphenhydramine HClACETAMINOPHEN DIPHENHYDRAMINE HCLBETTER LIVING BRANDS LLC.ac0f8d5c-d200-1156-e053-2a95a90aece62025-12-18WarningsExact identifier
application number: M013
Pain and Fever ChildrensACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDe55645ab-66f9-4160-8247-395bc5b027112025-12-18WarningsExact identifier
application number: M013
Dolex ForteACETAMINOPHEN, ASPIRIN, CAFFEINEPharmadel LLC3c2d90fc-130d-476c-e063-6294a90a8c152025-12-17WarningsExact identifier
application number: M013
CareOne Childrens AcetaminophenACETAMINOPHENAmerican Sales Company07bc6632-fabb-427d-81f3-c27c54caa6a02025-12-17WarningsExact identifier
application number: M013
MAXIMUM STRENGTH NON-ASPIRIN 100ACETAMINOPHENJHK Inc dba American Safety & First Aid1d3e9948-883e-4668-9bb8-d699a283b51a2025-12-16WarningsExact identifier
application number: M013
TYLENOL EXTRA STRENGTH, TRAVEL BASIXACETAMINOPHENLil' Drug Store Products, Inc.fa951d50-b79c-4161-8c81-fcf386b0964e2025-12-15WarningsExact identifier
application number: M013
Vanquish Extra StrengthACETAMINOPHEN, ASPIRIN, AND CAFFEINEDSE Healthcare Solutions, LLCcbf12223-ef44-494b-9d3c-971dce3c5ade2025-12-15WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED8bc75bcf-01c9-41d0-a96f-77a24e3edf012025-12-15WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWALGREENS40a1b354-9b2e-1cf3-e063-6394a90af1132025-12-13WarningsExact identifier
application number: M013
topcare childrens pain and feverACETAMINOPHENTopco Associates LLC911492d5-e065-4b8f-b2dc-cb6a6678d0ae2025-12-13WarningsExact identifier
application number: M013
Pain Reliever, Extra Strength, 24-7 Life by 7-ElevenACETAMINOPHEN TABLETLil' Drug Store Products, Inc.45c397bd-a1ff-1246-e063-6394a90ac54a2025-12-12WarningsExact identifier
application number: M013
Pain Reliever PM, Extra Strength, 24-7 Life by 7-ElevenACETAMINOPHEN, DIPHENHYDRAMINE HCL TABLET, FILM COATEDLil' Drug Store Products, Inc.45c7c11b-d627-aee8-e063-6294a90a401d2025-12-12WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307668acetaminophen 160 MG in 5 mL Oral SuspensionPSNcaf5daea-409e-5dd2-e053-2995a90acb125
307668acetaminophen 32 MG/ML Oral SuspensionSCDcaf5daea-409e-5dd2-e053-2995a90acb125
307668acetaminophen 160 MG per 5 ML Oral SuspensionSYcaf5daea-409e-5dd2-e053-2995a90acb125
307668acetaminophen 320 MG per 10 ML Oral SuspensionSYcaf5daea-409e-5dd2-e053-2995a90acb125
307668acetaminophen 650 MG per 20.3 ML Oral SuspensionSYcaf5daea-409e-5dd2-e053-2995a90acb125
307668acetaminophen 80 MG per 2.5 ML Oral SuspensionSYcaf5daea-409e-5dd2-e053-2995a90acb125
307668APAP 32 MG/ML Oral SuspensionSYcaf5daea-409e-5dd2-e053-2995a90acb125

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-0941-000012109410010 TRAY in 1 CASE (0121-0941-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0941-05) 10 tray2021-09-030000-00-00NoNoCurrent
0121-0941-05001210941055 mL in 1 CUP, UNIT-DOSE5 mlHistorical
0121-0941-94001210941943 TRAY in 1 CASE (0121-0941-94) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0941-05) 3 tray2021-09-030000-00-00NoNoCurrent