FDA.reportPublic FDA data

TYLENOL EXTRA STRENGTH, CVP HEALTH

Product NDC
66715-6547
11-digit product format
667156547
Labeler code
66715
Product ID
66715-6547_460387da-80ba-42ee-e063-6394a90a5957
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Lil' Drug Store Products, Inc.
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-05-06
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
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
TYLENOL EXTRA STRENGTH, CVP HEALTH
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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198440Internal RxNorm lookup
209459Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fa951d50-b79c-4161-8c81-fcf386b0964eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66715-6547-2TYLENOL EXTRA STRENGTH, CVP HEALTH2 in 1 CARTONTABLET, COATED211
66715-6547-2TYLENOL EXTRA STRENGTH, CVP HEALTH2 in 1 POUCHTABLET, COATED211

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DTYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
AcetaminophenACTIVE MOIETY362O9ITL9DTYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
aluminum oxideINACTIVE INGREDIENTLMI26O6933TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
carnauba waxINACTIVE INGREDIENTR12CBM0EIZTYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
castor oilINACTIVE INGREDIENTD5340Y2I9GTYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
FD&C red no. 40INACTIVE INGREDIENTWZB9127XOATYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
hypromellosesINACTIVE INGREDIENT3NXW29V3WOTYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ATYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
powdered celluloseINACTIVE INGREDIENTSMD1X3XO9MTYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
propylene glycolINACTIVE INGREDIENT6DC9Q167V3TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
shellacINACTIVE INGREDIENT46N107B71OTYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
starch, cornINACTIVE INGREDIENTO8232NY3SJTYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-6547TYLENOL EXTRA STRENGTH, TRAVEL BASIX (ACETAMINOPHEN) TABLET, COATED TYLENOL EXTRA STRENGTH, CVP HEALTH (ACETAMINOPHEN) TABLET, COATED TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]10Current NDC, 2 package rows20240120_fa951d50-b79c-4161-8c81-fcf386b0964e.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 20 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Excedrin Rapid ReliefACETAMINOPHENHaleon US Holdings LLC3a36b7ca-396e-cfd8-e063-6294a90a76ab2026-02-22WarningsExact identifier
application number: M013
CHILDRENS AcetaminophenCHILDRENS ACETAMINOPHENKesin Pharma Corporation4af5b025-1fd7-e825-e063-6294a90aa0052026-02-16WarningsExact identifier
application number: M013
Infants TYLENOLACETAMINOPHENKenvue Brands LLC4a121a53-dbae-05c7-e063-6294a90aed892026-02-13WarningsExact identifier
application number: M013
MAX relief junior GrapeCHILDRENS ACETAMINOPHENATLANTIC BIOLOGICALS CORP.562d7901-44d6-4d9b-be8b-a8d468a22c432026-02-13WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENMajor Pharmaceuticals020fa486-31f0-4e0c-84d3-5b3aaded1eeb2026-02-13WarningsExact identifier
application number: M013
ASPIRIN Low StrengthASPIRINCVS Pharmacy6e1c1129-562b-4a8a-ac37-db3cb2a827352026-02-11WarningsExact identifier
application number: M013
CVS AcetaminophenACETAMINOPHENCVS Pharmacy3dd21aaf-13b2-9e81-e063-6294a90afaec2026-02-11WarningsExact identifier
application number: M013
Pain Relief PMACETAMINOPHEN, ASPIRIN, DIPHENHYDRAMINE CITRATECVS Pharmacyddd78b28-6e10-4708-bed1-8aea087b3d822026-02-11WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENTopco Associates, LLC2e31fe65-5f50-455b-99fa-c72879f435452026-02-10WarningsExact identifier
application number: M013
Pain Relief ChildrensACETAMINOPHENAmerisource Bergen9ea8bb1f-1924-4430-98bd-f2674d0da7482026-02-09WarningsExact identifier
application number: M013
Acetaminophen , Caffeine and pyrilamine maleateACETAMINOPHEN , CAFFEINE AND PYRILAMINE MALEATESoftgel Healthcare Pvt Ltd4a61313e-1b48-29df-e063-6394a90a27f02026-02-09WarningsExact identifier
application number: M013
good sense aspirinASPIRINL. Perrigo Companye9fddbc1-11fe-4cf6-8794-1650fa1b32ae2026-02-07WarningsExact identifier
application number: M013
AspirinASPIRINChain Drug Marketing Association, Inc.2d375ec9-a528-4048-a15b-652fa20e74a72026-02-06WarningsExact identifier
application number: M013
Adult Low Dose Enteric Coated AspirinASPIRINSportpharm LLCd3379569-7949-4f78-b634-5d4178b21ea42026-02-06WarningsExact identifier
application number: M013
Buffered AspirinASPIRINCardinal Health 110, LLC. DBA Leadere5f68c1a-21f3-45a1-861f-229a95b3721c2026-02-06WarningsExact identifier
application number: M013
pain relief extra strengthACETAMINOPHENHyVee Inc1e707628-08b1-4c72-b71c-2b4ae96071f22026-02-06WarningsExact identifier
application number: M013
CareOne Acetaminophen PMACETAMINOPHEN, DIPHENHYDRAMINE HCLAmerican Sales Company2d2ded37-f241-4976-886d-5c038a85bfe12026-02-05WarningsExact identifier
application number: M013
Dolex FemACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEPharmadel LLCb1cab10b-19f1-f5d5-e053-2995a90a4d5f2026-02-05WarningsExact identifier
application number: M013
Alka-Seltzer Extra Strength Pain ReliefANHYDROUS CITRIC ACID, ASPIRINBayer HealthCare LLC.4a16b6e5-f0c6-e3a4-e063-6294a90a85ad2026-02-05WarningsExact identifier
application number: M013
Pain Relief childrensACETAMINOPHENCVS PHARMACYb8ab85a6-3eab-4ef4-a13d-5ac300480f632026-02-03WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNfa951d50-b79c-4161-8c81-fcf386b0964e11
209459Tylenol Extra Strength 500 MG Oral TabletPSNfa951d50-b79c-4161-8c81-fcf386b0964e11
209459acetaminophen 500 MG Oral Tablet [Tylenol]SBDfa951d50-b79c-4161-8c81-fcf386b0964e11
198440acetaminophen 500 MG Oral TabletSCDfa951d50-b79c-4161-8c81-fcf386b0964e11
198440APAP 500 MG Oral TabletSYfa951d50-b79c-4161-8c81-fcf386b0964e11
209459APAP 500 MG Oral Tablet [Tylenol]SYfa951d50-b79c-4161-8c81-fcf386b0964e11
209459Tylenol 500 MG Oral TabletSYfa951d50-b79c-4161-8c81-fcf386b0964e11
209459Tylenol Extra Strength 500 MG Oral TabletSYfa951d50-b79c-4161-8c81-fcf386b0964e11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
66715-6547-2667156547022 POUCH in 1 CARTON (66715-6547-2) / 2 TABLET, COATED in 1 POUCH2 pouch2022-05-06NoNoCurrent