FDA.reportPublic FDA data

Acetaminophen

Product NDC
0121-1047
11-digit product format
001211047
Labeler code
0121
Product ID
0121-1047_ba8d56c1-521e-490b-a83e-ebfa2d51bd8b
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
SOLUTION
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-09
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
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
fac4e0c6-684f-45a1-99f2-de4de4017cc8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-1047-00Acetaminophen10 in 1 TRAYSOLUTION103
0121-1047-00Acetaminophen10 in 1 CASESOLUTION103
0121-1047-05Acetaminophen5 mL in 1 CUP, UNIT-DOSESOLUTION53

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-1047-00ML - Milliliter0121-1047010e68ff-88f2-49e0-a6ec-8d3f015bd9ae12026-01-08
0121-1047-05ML - Milliliter0121-104793277862-3358-4c4c-baea-8af76ea16da312026-01-08

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 31 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLWalgreen Companyb4d8860b-d72f-4789-945e-1c6420a8efab2025-12-02WarningsExact identifier
application number: M013
Infants Pain and FeverACETAMINOPHENWALGREEN COMPANYf7b304d8-e37c-4ac6-b4a2-1797b92cb8322025-12-01WarningsExact identifier
application number: M013
Dye FreeInfants Pain and FeverACETAMINOPHENWALGREEN COMPANY1a304570-88b6-4c16-a8b4-c064bfa5d95a2025-12-01WarningsExact identifier
application number: M013
Walgreen Severe Multi-Symptom Cough Cold FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWALGREENSb48d93fe-bb60-493f-8d1a-b2dc864203c42025-12-01WarningsExact identifier
application number: M013
Multi Symptom Severe Cold and Nighttime Severe Cold and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCLWALGREEN CO.6c4ab613-a587-4ec4-9986-f1d000bc2d232025-12-01WarningsExact identifier
application number: M013
WAG HBP Daytime and Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATEWALGREENS CO.ac2f9ce8-e402-4451-a412-e99248a6ecbe2025-12-01WarningsExact identifier
application number: M013
Walgreen Day Time NightTime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE,GUAIFENESINWALGREENS CO.5505217a-9679-4668-bdab-5d4553a47c562025-12-01WarningsExact identifier
application number: M013
CAREALL AspirinASPIRINNew World Imports, Inc58a371d4-1f00-4fda-8e08-80610c58505a2025-12-01WarningsExact identifier
application number: M013
CareALL Non Aspirin Extra StrengthACETAMINOPHENNew World Imports, Incda05a1a1-35b4-4787-8c56-12e369f18ff02025-12-01WarningsExact identifier
application number: M013
CareALL Acetaminophen Extra StrengthACETAMINOPHENNew World Imports, Inc80a699b9-bf5c-4765-9e20-ccbc7e3ace7a2025-12-01WarningsExact identifier
application number: M013
CareALL Acetaminophen Extra StrengthACETAMINOPHENNew World Imports, Inc66244cdb-2680-4fa8-890d-32aefd4900382025-12-01WarningsExact identifier
application number: M013
Family Wellness Childrens Pain Reliever 574ACETAMINOPHENFamily Dollar Services, Inc.902c1136-04d2-41f0-81c6-412663cdf3782025-12-01WarningsExact identifier
application number: M013
WalgreenChildrens Pain FeverACETAMINOPHENWALGREENS CO.2f757cde-2604-4ca4-b54e-e444f3757cdd2025-11-26WarningsExact identifier
application number: M013
Walgreen Childrens Pain plus FeverACETAMINOPHENWALGREENS CO.29ca2855-3c07-435d-a8e1-2997fcedd0882025-11-26WarningsExact identifier
application number: M013
Walgreens Childrens Cold plus Cough plus Runny NoseACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDEWALGREENS CO.8714d4e6-3a3b-48c8-8ac1-51b933a2ceac2025-11-26WarningsExact identifier
application number: M013
Pain Reliever, 24/7 Life by 7-ElevenACETAMINOPHEN TABLET, FILM COATEDLil' Drug Store Products, Inc.44828b89-2563-b233-e063-6294a90ab1242025-11-26WarningsExact identifier
application number: M013
MEMBERS MARK ACETAMINOPHENACETAMINOPHENSam's West Inc03e831d4-8060-4633-9d02-e77100063fb42025-11-26WarningsExact identifier
application number: M013
Childrens Pain and Fever Dissolve PacksACETAMINOPHENWALGREENS CO.ea0f265f-7d64-4731-beda-0bb841dd1ad72025-11-25WarningsExact identifier
application number: M013
Sore Throat Logenzes Sore ThroatBENZOCAINE AND MENTHOLATLANTIC BIOLOGICALS CORP.71a80e13-bda3-40fb-b4e7-45e9985e707c2025-11-24WarningsExact identifier
application number: M013
better living brands childrens fever and pain reliverACETAMINOPHENBETTER LIVING BRANDS LLCc13ced61-c491-4fc2-b83f-78c6d9ad85462025-11-20WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307675acetaminophen 160 MG in 5 mL Oral SolutionPSNfac4e0c6-684f-45a1-99f2-de4de4017cc83
307675acetaminophen 32 MG/ML Oral SolutionSCDfac4e0c6-684f-45a1-99f2-de4de4017cc83
307675acetaminophen 160 MG per 5 ML Oral SolutionSYfac4e0c6-684f-45a1-99f2-de4de4017cc83
307675acetaminophen 325 MG per 10.15 ML Oral SolutionSYfac4e0c6-684f-45a1-99f2-de4de4017cc83
307675acetaminophen 650 MG per 20.3 ML Oral SolutionSYfac4e0c6-684f-45a1-99f2-de4de4017cc83
307675acetaminophen 80 MG per 2.5 ML Oral SolutionSYfac4e0c6-684f-45a1-99f2-de4de4017cc83
307675APAP 32 MG/ML Oral SolutionSYfac4e0c6-684f-45a1-99f2-de4de4017cc83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0121-1047-000012110470010 TRAY in 1 CASE (0121-1047-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-1047-05) 10 tray2025-12-09NoNoCurrent
0121-1047-05001211047055 mL in 1 CUP, UNIT-DOSE5 mlHistorical