FDA.reportPublic FDA data

TYLENOL SINUS PLUS HEADACHE

Product NDC
50580-598
11-digit product format
505800598
Labeler code
50580
Product ID
50580-598_21acf19d-d051-97ca-e063-6294a90a5e41
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen and Phenylephrine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Kenvue Brands LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-07-15
Substance
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 5 mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
TYLENOL SINUS PLUS HEADACHE
Brand name suffix
DAY
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 04JA59TNSJ
Rxcui1046378

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-598-01TYLENOL SINUS PLUS HEADACHEDAY12 in 1 BLISTER PACKTABLET, FILM COATED1214
50580-598-01TYLENOL SINUS PLUS HEADACHEDAY2 in 1 CARTONTABLET, FILM COATED214
50580-598-02TYLENOL SINUS PLUS HEADACHEDAY2 in 1 CARTONTABLET, FILM COATED214
50580-598-02TYLENOL SINUS PLUS HEADACHEDAY12 in 1 BLISTER PACKTABLET, FILM COATED1214

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-598-02EA - Each50580-5987a916260-3b4f-4ee4-a69d-a2595f6b2cca12022-05-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DTYLENOL SINUS PLUS HEADACHE DAY (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]1
Phenylephrine hydrochlorideACTIVE INGREDIENT04JA59TNSJTYLENOL SINUS PLUS HEADACHE DAY (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]1
AcetaminophenACTIVE MOIETY362O9ITL9DTYLENOL SINUS PLUS HEADACHE DAY (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]1
PhenylephrineACTIVE MOIETY1WS297W6MVTYLENOL SINUS PLUS HEADACHE DAY (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]1
aluminum oxideINACTIVE INGREDIENTLMI26O6933TYLENOL SINUS PLUS HEADACHE DAY (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]1
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLTYLENOL SINUS PLUS HEADACHE DAY (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]1
carnauba waxINACTIVE INGREDIENTR12CBM0EIZTYLENOL SINUS PLUS HEADACHE DAY (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UTYLENOL SINUS PLUS HEADACHE DAY (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]1
D&C yellow no. 10INACTIVE INGREDIENT35SW5USQ3GTYLENOL SINUS PLUS HEADACHE DAY (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]1
FD&C blue no. 1INACTIVE INGREDIENTH3R47K3TBDTYLENOL SINUS PLUS HEADACHE DAY (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]1
FD&C red no. 40INACTIVE INGREDIENTWZB9127XOATYLENOL SINUS PLUS HEADACHE DAY (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]1
hypromellosesINACTIVE INGREDIENT3NXW29V3WOTYLENOL SINUS PLUS HEADACHE DAY (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]1
magnesium stearateINACTIVE INGREDIENT70097M6I30TYLENOL SINUS PLUS HEADACHE DAY (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]1
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ATYLENOL SINUS PLUS HEADACHE DAY (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HTYLENOL SINUS PLUS HEADACHE DAY (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]1
potassium sorbateINACTIVE INGREDIENT1VPU26JZZ4TYLENOL SINUS PLUS HEADACHE DAY (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]1
powdered celluloseINACTIVE INGREDIENTSMD1X3XO9MTYLENOL SINUS PLUS HEADACHE DAY (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUTYLENOL SINUS PLUS HEADACHE DAY (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]1
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRTYLENOL SINUS PLUS HEADACHE DAY (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]1
sodium starch glycolate type a potatoINACTIVE INGREDIENT5856J3G2A2TYLENOL SINUS PLUS HEADACHE DAY (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]1
sucraloseINACTIVE INGREDIENT96K6UQ3ZD4TYLENOL SINUS PLUS HEADACHE DAY (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTYLENOL SINUS PLUS HEADACHE DAY (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-598TYLENOL SINUS PLUS HEADACHE DAY (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [KENVUE BRANDS LLC]14Current NDC, Legacy NDC, 4 package rows20241109_e608d214-cc46-4a24-ac85-1040e36e7403.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046378acetaminophen 325 MG / phenylephrine HCl 5 MG Oral TabletPSNe608d214-cc46-4a24-ac85-1040e36e740314
1046378acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDe608d214-cc46-4a24-ac85-1040e36e740314
1046378APAP 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSYe608d214-cc46-4a24-ac85-1040e36e740314

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-598-01505800598012 BLISTER PACK in 1 CARTON (50580-598-01) > 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2015-07-150000-00-00NoNoCurrent
50580-598-02505800598022 BLISTER PACK in 1 CARTON (50580-598-02) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2019-05-080000-00-00NoNoCurrent