Acetaminophen 500mg

Product NDC
70692-117
11-digit product format
706920117
Labeler code
70692
Product ID
70692-117_b43d776e-b5f3-16b9-e053-2995a90a66b9
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen 500mg
Dosage form
TABLET
Route
ORAL
Labeler
Strive Pharmaceuticals Inc
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2018-12-20
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70692-117IInactivated by FDA2026-07-31
excluded packagepackage70692-11770692-117-06IInactivated by FDA2026-07-31
excluded packagepackage70692-11770692-117-41IInactivated by FDA2026-07-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good Sense Pain and FeverACETAMINOPHENPreferred Pharmaceuticals Inc.7dbd0a2d-8597-4010-bfe2-94a8d145ca572026-03-27WarningsExact identifier
AcetaminophenACETAMINOPHENAphena Pharma Solutions - Tennessee, LLC89134c3e-ec5b-4a57-952a-98d6c6cff7c22019-02-26WarningsExact identifier
CounterAct PMACETAMINOPHEN AND DIPHENHYDRAMINEMelaleuca, Inc.7f9a0062-0e86-1deb-e053-2a91aa0a91882019-01-18WarningsExact identifier
Low Dose Miniprin Enteric Safety CoatedASPIRINTime-Cap Labs, Inc5a38a643-55b0-4a6c-84e1-ee23744351142018-12-19WarningsExact identifier
Low Dose Aspirin Enteric Safety CoatedASPIRINTime-Cap Labs, Inc55d645bb-8645-4984-a7b9-3e6eed8c64122018-12-17WarningsExact identifier
ACETAMINOPHENACETAMINOPHENTIME CAP LABORATORIES, INC2569383a-4a05-4ddb-852e-b37e487ffcde2018-12-17WarningsExact identifier
Low Dose Aspirin Enteric Safety CoatedASPIRINTime-Cap Labs, Inc9cb0c2df-5e72-42c5-ae93-144201fd263c2018-12-17WarningsExact identifier
ASPIRIN EXTRA STRENGTHASPIRINTime-Cap Labs, Incefc7d42a-241a-422d-bc08-be2f5f774b622018-12-17WarningsExact identifier
aspirin low dose enteric coatedASPIRINTime-Cap Labs, Inc5aaf8b66-b00e-4bc8-972c-bbe6825284fb2018-12-17WarningsExact identifier
aspirin low dose enteric coatedASPIRINTime-Cap Labs, Inc7146c505-2469-4bc2-9e1e-ceb60951c8ae2018-12-17WarningsExact identifier
Comfort-TimeACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATETime Cap Labs, Ince94a26a2-36e5-4e1e-aea1-24e035c980432018-12-14WarningsExact identifier
Aspirin Delayed ReleaseASPIRINTime-Cap Labs, Inc70d8ba6c-8dfe-402a-817d-22544141d1602018-12-14WarningsExact identifier
Geritrex AspirinASPIRINGeritrex LLC93fb4359-c93d-46c4-b36e-611b829f514c2018-10-10WarningsExact identifier
Pain Relief PMACETAMINOPHEN PMVelocity Pharmac1c1de91-6a54-4d91-93a9-b6be6d7c7dfb2018-05-14WarningsExact identifier
AcetaminophenACETAMINOPHENVelocity Pharma LLCbba2ddc5-19e0-4f11-8ff7-7dd7c2d53b502018-05-14WarningsExact identifier
AspirinASPIRINAphena Pharma Solutions - Tennessee, LLC49f46b08-b2fe-4e4d-b235-983dab9740cc2018-02-18WarningsExact identifier
AcetaminophenACETAMINOPHENAdvance Pharmaceutical Inc.3793a17e-13bf-4d27-b8fa-6753b760f8202017-12-22WarningsExact identifier
APAPACETAMINOPHENAdvance Pharmaceutical Inc.aba26f0a-94e4-4919-a3b0-033e3a9598ef2017-12-22WarningsExact identifier
APAPACETAMINOPHENAdvance Pharmaceutical Inc.5c75dc7f-06ae-440e-90ed-d7753eaa786e2017-12-22WarningsExact identifier
Extra Strength AcetaminophenACETAMINOPHENPuraCap Pharmaceutical LLCf3c57374-1408-4459-a4de-ad12c2fc6b612017-11-09WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes • more than 5 doses in 24 hours, which is the maximum daily amount • with other drugs containing acetaminophen Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: • skin reddening • blisters • rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. Do not use • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. • if your child has ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if your child has liver disease Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin When using this product do not exceed recommended dose (see overdose warning) Stop use and ask a doctor if • pain gets worse or lasts more than 5 days • fever gets worse or lasts more than 3 days • new symptoms occur • redness or swelling is present These could be signs of a serious condition. Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70692-117-062022-01-28C16284748780-1d6a99b39-4a87-a426-e053-dadaa90af4c2Acetaminophen 500mg
70692-117-412022-01-28C16284748780-1d6a99b39-4a87-a426-e053-dadaa90af4c2Acetaminophen 500mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70692-117-06Acetaminophen 500mg60 in 1 BOTTLETABLET603
70692-117-41Acetaminophen 500mg4 in 1 PACKAGETABLET43

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70692-117ACETAMINOPHEN 500MG TABLET [STRIVE PHARMACEUTICALS INC]3Legacy NDC, 2 package rows20201117_92210dcd-a87f-2b74-e053-2a95a90ac034.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSN92210dcd-a87f-2b74-e053-2a95a90ac0343
198440acetaminophen 500 MG Oral TabletSCD92210dcd-a87f-2b74-e053-2a95a90ac0343
198440APAP 500 MG Oral TabletSY92210dcd-a87f-2b74-e053-2a95a90ac0343

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70692-117-067069201170660 TABLET in 1 BOTTLE (70692-117-06) 60 tablet2018-12-200000-00-00NoNoCurrent
70692-117-41706920117414 TABLET in 1 PACKAGE (70692-117-41) 4 tablet2018-12-200000-00-00NoNoCurrent