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 65 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HCLDIPHENHYDRAMINE HCLNuCare Pharmaceuticals, Inc.5411544e-3c2d-4e42-e054-00144ff8d46c2024-07-10WarningsExact identifier
application number: M013
good sense pain relief pm extra strengthACETAMINOPHEN, DIPHENHYDRAMINE HCLL. Perrigo Companyb97c51ad-4953-4491-9ceb-395550eb52962024-07-10WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEWalgreens065e6f1b-f68c-491a-a157-84961a07e3d92024-07-10WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEWalgreens3b7b6725-2996-44d3-89a3-032384e7e2ce2024-07-10WarningsExact identifier
application number: M013
equate pain and fever infantsACETAMINOPHENWal-Mart Stores Inc8a152c8d-8ae0-4201-8bb9-7b22c35774152024-07-10WarningsExact identifier
application number: M013
Acetaminophen PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEWinCo Foods, LLC3c57498c-86b0-4ba3-881e-c742a2e8ece52024-07-09WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENWinCo Foods, LLCc358d1dd-9fcb-4d18-9521-8f898b98a7322024-07-09WarningsExact identifier
application number: M013
Acetaminophen Regular StrengthACETAMINOPHENWinCo Foods, LLC15430025-f25e-4fe7-b1fe-4eda4684081a2024-07-09WarningsExact identifier
application number: M013
Acetaminophen Easy Tabs Extra StrengthACETAMINOPHENWinCo Foods, LLC0631f003-4852-4034-a1c5-1552804b16602024-07-09WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINBryant Ranch Prepack61ecf3c9-42fa-4ae4-bd3b-694090477b9a2024-07-09WarningsExact identifier
application number: M013
Panadol Cold and Flu NonDrowsyACETAMINOPHEN AND PHENYLEPRINE HCLHaleon US Holdings LLCfa0ce51f-441d-4409-8617-b3402b00f1872024-07-08WarningsExact identifier
application number: M013
Pain and FeverACETAMINOPHENMeijer Distribution Inc81d4e8f5-2f15-462b-be71-ef05f0b791ab2024-07-05WarningsExact identifier
application number: M013
Extra Strength Pain ReliefACETAMINOPHENBryant Ranch Prepack31a97a6a-e5c8-429a-b497-330f0d84777d2024-07-05WarningsExact identifier
application number: M013
pain and feverACETAMINOPHENMeijer Distribution Inc375b2142-3c89-469c-98fd-bd4b63aeaa112024-07-05WarningsExact identifier
application number: M013
Best Choice Effervescent Pain Reliever 36ASPIRINVALU MERCHANDISERS COMPANY12f1278e-88b6-0460-e063-6394a90abf0e2024-07-03WarningsExact identifier
application number: M013
Topcare pain and feverACETAMINOPHENTopco Associates LLC950b16d5-65db-402d-8ec6-eec9e1e174dd2024-07-03WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENWALMART INC.16d5b56f-7e56-0c91-e063-6394a90a4b8e2024-07-03WarningsExact identifier
application number: M013
Acetaminophen and Diphenhydramine hydrochlorideACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEWALMART INC.16d5786c-2346-f970-e063-6394a90a0a8c2024-07-03WarningsExact identifier
application number: M013
topcare infants pain and feverACETAMINOPHENTopco Associates LLCa1145ac3-3e55-4bd5-a53e-6cf869add9a12024-07-02WarningsExact identifier
application number: M013
Drug Mart Effervescent Pain ReliefASPIRINDiscount Drug Mart Inc1c35f394-a221-6531-e063-6394a90acb8a2024-07-01WarningsExact 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