Extra Strength Acetaminophen

Product NDC
69732-001
Requested package NDC
69732-001-01
11-digit product format
697320001
Labeler code
69732
Product ID
69732-001_55f92c95-a399-6cf1-e063-6394a90a07af
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Hi-Tech Nutraceuticals, LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-04-30
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
Extra Strength Acetaminophen
Listing expiration
2027-12-31

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
a36be487-7a36-550f-e053-2a95a90a95c1Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69732-001-012023-01-30C16284748780-1f386c64a-30ea-0266-e053-dadaa90a7c1aa36be487-7a36-550f-e053-2a95a90a95c1
69732-001-012023-01-30C16284748780-1f386c64a-30ea-0266-e053-dadaa90a7c1aa36be487-7a36-550f-e053-2a95a90a95c1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69732-001-01Extra Strength Acetaminophen30 in 1 BOTTLE, PLASTICTABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69732-001EXTRA STRENGTH ACETAMINOPHEN (ACETAMINOPHEN) TABLET [HI-TECH NUTRACEUTICALS, LLC]2Current NDC, Legacy NDC, 1 package rows20200430_a36be487-7a36-550f-e053-2a95a90a95c1.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 70 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Excedrin Extra Strength Pain RelieverACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINEHaleon US Holdings LLCa71074a6-cc19-4bb3-8c84-4e82a89068012024-04-22WarningsExact identifier
application number: M013
Regular Strength AcetaminophenACETAMINOPHENKROGER COMPANY0fe995cd-f974-db04-e063-6294a90a33552024-04-18WarningsExact identifier
application number: M013
Regular Strength Aspirin 325 mgASPIRINKroger0fc3193d-af4e-ff3a-e063-6294a90a27432024-04-17WarningsExact identifier
application number: M013
Childrens Pain and Fever Dye FreeACETAMINOPHENKROGER COMPANY0fec66b4-3a2a-63d1-e063-6294a90a6d722024-04-17WarningsExact identifier
application number: M013
aspirin low dose chewableASPIRINTime-Cap Labs, Inc5d56618c-8ea2-42ea-a9f2-339bd0055ddd2024-04-17WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINP & L Development, LLC0058175f-3474-40c3-a046-6cfaec86d84b2024-04-16WarningsExact identifier
application number: M013
Handy Solutions Headache Pain ReliefACETAMINOPHEN, ASPIRIN, CAFFEINENavajo Manufacturing Company Inc.e5481abe-6971-2bc5-e053-2995a90ae8952024-04-15WarningsExact identifier
application number: M013
childrens acetaminophenACETAMINOPHENMajor Pharmaceuticals243a5cff-e506-434b-ab19-1a6ac53f85332024-04-15WarningsExact identifier
application number: M013
Dye Free Pain Reliever ChildrensACETAMINOPHENP & L Development, LLC45ddcaad-d416-4d7c-a84a-43548d5c5d3b2024-04-15WarningsExact identifier
application number: M013
Tylenol Extra StrengthACETAMINOPHENNavajo Manufacturing Company Inc.65bf1556-f25a-9439-e053-2a91aa0a31942024-04-15WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENKroger Companybbeebdd6-fe2c-5b8a-e053-2a95a90ab95e2024-04-13WarningsExact identifier
application number: M013
infants pain reliefACETAMINOPHENPublix Super Markets Inc3d1818a7-d3b2-434c-b3c9-b2713f08ded22024-04-13WarningsExact identifier
application number: M013
Mommys Bliss Childrens Pain and FeverACETAMINOPHENMom Enterprises, LLC.08b9eaf7-70d1-640f-e063-6394a90a8d3b2024-04-12WarningsExact identifier
application number: M013
Mommys Bliss Infants Pain and FeverACETAMINOPHENMom Enterprises, LLC.05e26650-81b3-d7b1-e063-6394a90a14ed2024-04-11WarningsExact identifier
application number: M013
Childrens Pain ReliefCHILDRENS PAIN RELIEFAllegiant Health7381dd26-c507-4d02-b989-cfd96e02f4952024-04-11WarningsExact identifier
application number: M013
Childrens Pain Relief Dye-FreeACTEAMINOPHENWinCo Foods, LLC5ee134b3-b8e9-4621-b0a1-a84d9867ccba2024-04-11WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENWALGREENS0b1d086f-7be1-5072-e063-6394a90a11e62024-04-10WarningsExact identifier
application number: M013
Dye Free Infants Pain and FeverACETAMINOPHENWALGREENS0b1d88d8-56ff-9e9d-e063-6394a90a015c2024-04-09WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEH E B4d572228-3141-4539-9c3d-2fd06e94eee32024-04-09WarningsExact identifier
application number: M013
Excedrin Extra Strength Pain RelieverACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINEHaleon US Holdings LLC1b5ff867-5442-4cf8-bd1e-530093cc88f82024-04-05WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNa36be487-7a36-550f-e053-2a95a90a95c12
198440acetaminophen 500 MG Oral TabletSCDa36be487-7a36-550f-e053-2a95a90a95c12
198440APAP 500 MG Oral TabletSYa36be487-7a36-550f-e053-2a95a90a95c12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69732-001-016973200010130 TABLET in 1 BOTTLE, PLASTIC (69732-001-01) 30 tablet2020-04-300000-00-00NoNoCurrent