Acetaminophen 500mg Caffeine 65mg

Product NDC
70692-110
11-digit product format
706920110
Labeler code
70692
Product ID
70692-110_b43d36ae-9a0a-8e9a-e053-2995a90af293
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen 500mg Caffeine 65mg
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; CAFFEINE
Active strength
500 mg/1; 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 productproduct70692-110IInactivated by FDA2026-07-31
excluded packagepackage70692-11070692-110-41IInactivated 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.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70692-110-412022-01-28C16284748780-1d6a99b39-b351-a426-e053-dadaa90af4c2Headache - Dolor de Cabeza (Acetaminophen 500mg; Caffeine 65mg)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70692-110-41Acetaminophen 500mg Caffeine 65mg4 in 1 PACKAGETABLET42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70692-110ACETAMINOPHEN 500MG CAFFEINE 65MG TABLET [STRIVE PHARMACEUTICALS INC]2Legacy NDC, 1 package rows20201117_92355f58-ebb6-b78f-e053-2995a90a4aef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307686acetaminophen 500 MG / caffeine 65 MG Oral TabletPSN92355f58-ebb6-b78f-e053-2995a90a4aef2
307686acetaminophen 500 MG / caffeine 65 MG Oral TabletSCD92355f58-ebb6-b78f-e053-2995a90a4aef2
307686APAP 500 MG / Caffeine 65 MG Oral TabletSY92355f58-ebb6-b78f-e053-2995a90a4aef2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70692-110-41706920110414 TABLET in 1 PACKAGE (70692-110-41) 4 tablet2018-12-200000-00-00NoNoCurrent