FDA.reportPublic FDA data

Pain Reliever fever Reducer

Product NDC
69842-878
11-digit product format
698420878
Labeler code
69842
Product ID
69842-878_e15ec20e-e4d2-485c-a8df-0c2fd096d2eb
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
LIQUID
Route
ORAL
Labeler
CVS Pharmacy
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-04-30
Substance
ACETAMINOPHEN
Active strength
500 mg/15mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
Pain Reliever fever Reducer
Brand name suffix
Extra Strength
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/15mL

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
307684Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7b5263ad-01b7-4fc5-9384-4da8efe89e35Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-878-08Pain Reliever fever ReducerExtra Strength237 mL in 1 BOTTLE, PLASTICLIQUID2374

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69842-878-08ML - Milliliter69842-8784bed4a8c-df82-4cd1-8ba9-65ad0f59dda912020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-878PAIN RELIEVER FEVER REDUCER EXTRA STRENGTH (ACETAMINOPHEN) LIQUID [CVS PHARMACY]4Current NDC, Legacy NDC, 1 package rows20240308_7b5263ad-01b7-4fc5-9384-4da8efe89e35.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 15 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aspirin 81 mg Low DoseASPIRINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED23b29044-6389-42ea-839a-5351557a6ce32026-04-23WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED4a70867e-481d-4f01-9da3-d85663a1672e2026-04-23WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINUnited Natural Foods, Inc. dba UNFI07edcb31-d31d-4607-98c3-dcb1e062cc702026-04-22WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCardinal Health 107, LLCee50c5ee-1a61-4efc-aca9-42d897d6a3b82026-04-22WarningsExact identifier
application number: M013
AspirinASPIRINCVS PHARMACY904a2b21-d911-40c3-9e4b-59543ea5be4f2026-04-22WarningsExact identifier
application number: M013
Pamprin Multi-Symptom Maximum StrengthACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATEFocus Consumer Healthcare, LLC60b3286d-5698-df50-e053-2991aa0afbe22026-04-20WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENCVS PHARMACYaf6fe4a9-2d18-4fed-b952-0a7866f652512026-04-20WarningsExact identifier
application number: M013
Aspirin 81 mgASPIRINPreferred Pharmaceuticals Inc.ac7f11d2-cbfd-4610-a652-fc2f1ea41d7e2026-04-20WarningsExact identifier
application number: M013
Parry-500mg AcetaminophenACETAMINOPHENMDC PHARMACEUTICALS LIMITEDfb07ba10-3210-41bc-9310-c952118fdcf32026-04-17WarningsExact identifier
application number: M013
Aspirin NSAIDASPIRINValu Merchandisers Company0cc46a81-54c9-44b7-b384-79d25255eff22026-04-17WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINEValu Merchandisers Company99de2c41-59b0-42e7-847e-e51229c6164f2026-04-17WarningsExact identifier
application number: M013
Pain and Fever ChildrensACETAMINOPHENWalgreen Company1f3e2895-5ef7-4e6a-8d2e-b805d148f9802026-04-16WarningsExact identifier
application number: M013
Childrens TYLENOLACETAMINOPHENKenvue Brands LLCb297aff8-a08b-4d37-b168-800a56564cbd2026-04-16WarningsExact identifier
application number: M013
Childrens TylenolACETAMINOPHENKenvue Brands LLC9782fe86-d72a-4231-b1ba-d3f3b4ee49e32026-04-16WarningsExact identifier
application number: M013
Pain Relief PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HCLDOLGENCORP, LLC8e65478b-7a7b-416c-b8e3-23dad79f8cc12026-04-16WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINValu Merchandisers Companyc9e384e5-fa9b-4c75-b5e3-16eb8db662ef2026-04-16WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPreferred Pharmaceuticals Inc.b6abfbbb-9826-4cd6-940f-3a314480a5a52026-04-15WarningsExact identifier
application number: M013
Good Sense Pain and FeverACETAMINOPHENL. Perrigo Companyf7137fe6-582e-43a4-8302-90ca54cd1de32026-04-14WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCardinal Health 107, LLCe13656eb-513e-411e-bdae-35ff1ba7cfc12026-04-13WarningsExact identifier
application number: M013
CareOne AcetaminophenACETAMINOPHENAmerican Sales Companyb4f54465-3232-4685-9570-90be008765772026-04-12WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307684acetaminophen 500 MG in 15 mL Oral SolutionPSN7b5263ad-01b7-4fc5-9384-4da8efe89e354
307684acetaminophen 33.3 MG/ML Oral SolutionSCD7b5263ad-01b7-4fc5-9384-4da8efe89e354
307684APAP 1000 MG per 30 ML Oral SolutionSY7b5263ad-01b7-4fc5-9384-4da8efe89e354
307684APAP 167 MG per 5 ML Oral SolutionSY7b5263ad-01b7-4fc5-9384-4da8efe89e354
307684APAP 33.3 MG/ML Oral SolutionSY7b5263ad-01b7-4fc5-9384-4da8efe89e354
307684APAP 500 MG per 15 ML Oral SolutionSY7b5263ad-01b7-4fc5-9384-4da8efe89e354

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69842-878-0869842087808237 mL in 1 BOTTLE, PLASTIC (69842-878-08) 237 ml2018-04-300000-00-00NoNoCurrent