FDA.reportPublic FDA data

Acetaminophen

Product NDC
0121-1971
11-digit product format
001211971
Labeler code
0121
Product ID
0121-1971_1f8166c0-62db-10f8-e063-6394a90a86cf
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
2007-08-01
Substance
ACETAMINOPHEN
Active strength
650 mg/20.3mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct0121-1971DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0121-19710121-1971-00DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…

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
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
6ec12573-03d6-40c1-9945-d345b401e062Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-1971-00Acetaminophen10 in 1 TRAYSOLUTION1015
0121-1971-00Acetaminophen10 in 1 CASESOLUTION1015
0121-1971-21Acetaminophen20.3 mL in 1 CUP, UNIT-DOSESOLUTION20.315

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-1971-00ML - Milliliter0121-19710810fe27-830b-41ad-af96-53d88d40b4a812017-03-06
0121-1971-21ML - Milliliter0121-197191884f5f-dfff-4883-ad2e-d5461d422e4012017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]2
AcetaminophenACTIVE MOIETY362O9ITL9DACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]2
SORBITOLINACTIVE INGREDIENT506T60A25RACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]2
SUCROSEINACTIVE INGREDIENTC151H8M554ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-1971ACETAMINOPHEN SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]15Current NDC, Legacy NDC, 3 package rows20240814_6ec12573-03d6-40c1-9945-d345b401e062.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 52 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equaline Effervescent Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEUnited Natural Foods, Inc. dba UNFI739237a5-cc62-8ad6-e053-2991aa0a91f82024-12-17WarningsExact identifier
application number: M013
NOTTS - Muscle Aches and PainACETAMINOPHENVIVUNT PHARMA LLCe6741300-4573-2580-e053-2a95a90a599c2024-12-17WarningsExact identifier
application number: M013
Extra Strength Pain Reliever, Caseys 4goodACETAMINOPHEN 500MG, FILM-COATED CAPLETLil' Drug Store Products, Inc.e5fc5340-c224-e02b-e053-2a95a90a52972024-12-16WarningsExact identifier
application number: M013
Pain Reliever, Caseys 4goodACETAMINOPHEN 500 MG, TABLETLil' Drug Store Products, Inc.039d2cf1-57f6-4d9d-e063-6394a90a54922024-12-16WarningsExact identifier
application number: M013
Extra Strength Headache, Caseys 4goodACETAMINOPHEN, ASPIRIN, CAFFEINE TABLETLil' Drug Store Products, Inc.0425c6a8-a3ea-24ad-e063-6294a90ae15a2024-12-16WarningsExact identifier
application number: M013
Lil Drug Store Childrens Pain and FeverACETAMINOPHENLil' Drug Store Products, Inc.5fcd41ad-449f-4090-be19-eae4171de8912024-12-16WarningsExact identifier
application number: M013
Acetaminophen 250mg Aspirin 250mg Caffeine 65mgACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MGCVS Pharmacyb9e75551-1e50-9896-e053-2a95a90aafd42024-12-14WarningsExact identifier
application number: M013
Acetaminophen 250mg Aspirin 250mg Caffeine 65mgACETAMINOPHEN 250MG ASPIRIN 250MG CAFFEINE 65MGCVS Pharmacyb9e5df0e-06d3-6f72-e053-2995a90a2d072024-12-14WarningsExact identifier
application number: M013
Alka-Seltzer Heartburn and PainANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATEBayer HealthCare LLC.2928e140-c868-5bf5-e063-6394a90ab0242024-12-13WarningsExact identifier
application number: M013
foster and thrive pain relieverACETAMINOPHENStrategic Sourcing Services LLCb8ee568c-80cf-4e35-865e-35516bdab0fd2024-12-13WarningsExact identifier
application number: M013
Headache ReliefACETAMINOPHEN, ASPIRIN, CAFFEINEStrive Pharmaceuticals Inc.c0de0bd2-4868-46dc-a20f-3ca02caaa26b2024-12-11WarningsExact identifier
application number: M013
Rite Aid Antacid and Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATERite Aidb4797380-9cef-d640-e053-2a95a90a06652024-12-11WarningsExact identifier
application number: M013
Top Value Effervescent Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICAROBONATETower Laboratories Ltd44babed8-cf38-1c12-e054-00144ff8d46c2024-12-11Warnings, Adverse reactionsExact identifier
application number: M013
Best Choice Effervescent Antacid Pain ReliefASPIRIN, CITRIC ACID, SODIUM BICARBONATEValu Merchandisers Companyb5e2300a-b77b-53cc-e053-2a95a90a7a6e2024-12-11WarningsExact identifier
application number: M013
EXTRA STRENGTH Headache Relief geltabsACETAMINOPHEN, ASPIRIN, CAFFEINEStrive Pharmaceuticals Inc.b432771a-4f7d-4d39-a038-d1561d8f67082024-12-11WarningsExact identifier
application number: M013
Pain Relief ChildrensACETAMINOPHENQUALITY CHOICE (Chain Drug Marketing Association)223ffb2b-3ee5-4118-955b-bc4fa4e8a2e62024-12-10WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENUNFIe689c9e3-dd4d-c646-e053-2a95a90a4b6a2024-12-09WarningsExact identifier
application number: M013
DrKids Childrens Pain and FeverACETAMINOPHEN 80MG/PIECECalmCo LLCff4b0528-39a0-80d5-e053-6394a90a8a832024-12-07WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDISCOUNT DRUG MART972f09a7-2aa1-4b1b-a6dc-2c4578a078032024-12-05WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENDISCOUNT DRUG MARTe6feff0a-3347-194d-e053-2a95a90acd202024-12-05WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307675acetaminophen 160 MG in 5 mL Oral SolutionPSN6ec12573-03d6-40c1-9945-d345b401e06215
307675acetaminophen 32 MG/ML Oral SolutionSCD6ec12573-03d6-40c1-9945-d345b401e06215
307675acetaminophen 160 MG per 5 ML Oral SolutionSY6ec12573-03d6-40c1-9945-d345b401e06215
307675acetaminophen 325 MG per 10.15 ML Oral SolutionSY6ec12573-03d6-40c1-9945-d345b401e06215
307675acetaminophen 650 MG per 20.3 ML Oral SolutionSY6ec12573-03d6-40c1-9945-d345b401e06215
307675acetaminophen 80 MG per 2.5 ML Oral SolutionSY6ec12573-03d6-40c1-9945-d345b401e06215
307675APAP 32 MG/ML Oral SolutionSY6ec12573-03d6-40c1-9945-d345b401e06215
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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-1971-000012119710010 TRAY in 1 CASE (0121-1971-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 20.3 mL in 1 CUP, UNIT-DOSE (0121-1971-21) 10 tray2007-08-010000-00-00NoNoCurrent
0121-1971-210012119712120.3 mL in 1 CUP, UNIT-DOSE20.3 mlHistorical