FDA.reportPublic FDA data

Acetaminophen

Product NDC
69842-298
11-digit product format
698420298
Labeler code
69842
Product ID
69842-298_04020582-1e29-0e5d-e063-6394a90a3b90
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
CVS PHARMACY, INC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-04-01
Substance
ACETAMINOPHEN
Active strength
500 mg/1
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 · 9 matching rows.

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

Dataset, Scope, Package NDC table
DatasetScopePackage NDC
excluded productproduct
excluded packagepackage69842-298-60
excluded packagepackage69842-298-30
excluded packagepackage69842-298-10
excluded packagepackage69842-298-40
excluded packagepackage69842-298-05
excluded packagepackage69842-298-24
excluded packagepackage69842-298-21
excluded packagepackage69842-298-15

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
ACETAMINOPHEN500 mg/1

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
198440Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
852e70e2-7279-6f33-e053-2991aa0a8676Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
69842-298-052023-03-13Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-102023-03-13Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-152023-03-13Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-212023-03-13Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-242023-03-13Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-302023-03-13Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-402023-03-13Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-602023-03-13Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-052023-01-30Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-102023-01-30Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-152023-01-30Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-212023-01-30Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-242023-01-30Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-302023-01-30Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-402023-01-30Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-602023-01-30Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-052020-12-29Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-102020-12-29Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-152020-12-29Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-212020-12-29Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-242020-12-29Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-302020-12-29Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-402020-12-29Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-602020-12-29Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-052020-09-27Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-102020-09-27Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-152020-09-27Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-212020-09-27Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-242020-09-27Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-302020-09-27Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-402020-09-27Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-602020-09-27Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-052020-09-25Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-102020-09-25Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-152020-09-25Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-212020-09-25Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-242020-09-25Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-302020-09-25Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-402020-09-25Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-602020-09-25Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-052020-07-22Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-102020-07-22Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-152020-07-22Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-212020-07-22Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-242020-07-22Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-302020-07-22Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-402020-07-22Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free
69842-298-602020-07-22Rapid Release Gelcaps EXTRA STRENGTH Acetaminophen Gelcaps USP, 500 mg Pain reliever; Fever reducer Aspirin free

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-298-05Acetaminophen50 in 1 BOTTLETABLET505
69842-298-10Acetaminophen100 in 1 BOTTLETABLET1005
69842-298-15Acetaminophen150 in 1 BOTTLETABLET1505
69842-298-21Acetaminophen225 in 1 BOTTLETABLET2255
69842-298-24Acetaminophen24 in 1 BOTTLETABLET245
69842-298-30Acetaminophen300 in 1 BOTTLETABLET3005
69842-298-40Acetaminophen400 in 1 BOTTLETABLET4005
69842-298-60Acetaminophen600 in 1 BOTTLETABLET6005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-298ACETAMINOPHEN TABLET [CVS PHARMACY, INC]5Current NDC, Legacy NDC, 8 package rows20231011_852e70e2-7279-6f33-e053-2991aa0a8676.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 65 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HCLDIPHENHYDRAMINE HCLNuCare Pharmaceuticals, Inc.5411544e-3c2d-4e42-e054-00144ff8d46c2024-07-10WarningsExact identifier
application number: M013
good sense pain relief pm extra strengthACETAMINOPHEN, DIPHENHYDRAMINE HCLL. Perrigo Companyb97c51ad-4953-4491-9ceb-395550eb52962024-07-10WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEWalgreens065e6f1b-f68c-491a-a157-84961a07e3d92024-07-10WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEWalgreens3b7b6725-2996-44d3-89a3-032384e7e2ce2024-07-10WarningsExact identifier
application number: M013
equate pain and fever infantsACETAMINOPHENWal-Mart Stores Inc8a152c8d-8ae0-4201-8bb9-7b22c35774152024-07-10WarningsExact identifier
application number: M013
Acetaminophen PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEWinCo Foods, LLC3c57498c-86b0-4ba3-881e-c742a2e8ece52024-07-09WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENWinCo Foods, LLCc358d1dd-9fcb-4d18-9521-8f898b98a7322024-07-09WarningsExact identifier
application number: M013
Acetaminophen Regular StrengthACETAMINOPHENWinCo Foods, LLC15430025-f25e-4fe7-b1fe-4eda4684081a2024-07-09WarningsExact identifier
application number: M013
Acetaminophen Easy Tabs Extra StrengthACETAMINOPHENWinCo Foods, LLC0631f003-4852-4034-a1c5-1552804b16602024-07-09WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINBryant Ranch Prepack61ecf3c9-42fa-4ae4-bd3b-694090477b9a2024-07-09WarningsExact identifier
application number: M013
Panadol Cold and Flu NonDrowsyACETAMINOPHEN AND PHENYLEPRINE HCLHaleon US Holdings LLCfa0ce51f-441d-4409-8617-b3402b00f1872024-07-08WarningsExact identifier
application number: M013
Pain and FeverACETAMINOPHENMeijer Distribution Inc81d4e8f5-2f15-462b-be71-ef05f0b791ab2024-07-05WarningsExact identifier
application number: M013
Extra Strength Pain ReliefACETAMINOPHENBryant Ranch Prepack31a97a6a-e5c8-429a-b497-330f0d84777d2024-07-05WarningsExact identifier
application number: M013
pain and feverACETAMINOPHENMeijer Distribution Inc375b2142-3c89-469c-98fd-bd4b63aeaa112024-07-05WarningsExact identifier
application number: M013
Best Choice Effervescent Pain Reliever 36ASPIRINVALU MERCHANDISERS COMPANY12f1278e-88b6-0460-e063-6394a90abf0e2024-07-03WarningsExact identifier
application number: M013
Topcare pain and feverACETAMINOPHENTopco Associates LLC950b16d5-65db-402d-8ec6-eec9e1e174dd2024-07-03WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENWALMART INC.16d5b56f-7e56-0c91-e063-6394a90a4b8e2024-07-03WarningsExact identifier
application number: M013
Acetaminophen and Diphenhydramine hydrochlorideACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEWALMART INC.16d5786c-2346-f970-e063-6394a90a0a8c2024-07-03WarningsExact identifier
application number: M013
topcare infants pain and feverACETAMINOPHENTopco Associates LLCa1145ac3-3e55-4bd5-a53e-6cf869add9a12024-07-02WarningsExact identifier
application number: M013
Drug Mart Effervescent Pain ReliefASPIRINDiscount Drug Mart Inc1c35f394-a221-6531-e063-6394a90acb8a2024-07-01WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSN852e70e2-7279-6f33-e053-2991aa0a86765
198440acetaminophen 500 MG Oral TabletSCD852e70e2-7279-6f33-e053-2991aa0a86765
198440APAP 500 MG Oral TabletSY852e70e2-7279-6f33-e053-2991aa0a86765

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-298-056984202980550 TABLET in 1 BOTTLE (69842-298-05) 50 tablet2019-04-010000-00-00NoNoCurrent
69842-298-1069842029810100 TABLET in 1 BOTTLE (69842-298-10) 100 tablet2019-04-010000-00-00NoNoCurrent
69842-298-1569842029815150 TABLET in 1 BOTTLE (69842-298-15) 150 tablet2019-04-010000-00-00NoNoCurrent
69842-298-2169842029821225 TABLET in 1 BOTTLE (69842-298-21) 225 tablet2019-04-010000-00-00NoNoCurrent
69842-298-246984202982424 TABLET in 1 BOTTLE (69842-298-24) 24 tablet2019-04-010000-00-00NoNoCurrent
69842-298-3069842029830300 TABLET in 1 BOTTLE (69842-298-30) 300 tablet2019-04-010000-00-00NoNoCurrent
69842-298-4069842029840400 TABLET in 1 BOTTLE (69842-298-40) 400 tablet2019-04-010000-00-00NoNoCurrent
69842-298-6069842029860600 TABLET in 1 BOTTLE (69842-298-60) 600 tablet2019-04-010000-00-00NoNoCurrent