FDA.reportPublic FDA data

SUDAFED PE Pressure Plus Pain

Product NDC
50580-547
11-digit product format
505800547
Labeler code
50580
Product ID
50580-547_217318f0-e484-c909-e063-6294a90a1bd1
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
2012-07-01
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
SUDAFED PE Pressure Plus Pain
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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50580-547-252024-02-06C16284748780-11030e365-0055-111a-e063-dadaa90a10e2SUDAFED PE ® Pressure+Pain
50580-547-732024-02-06C16284748780-11030e365-0055-111a-e063-dadaa90a10e2SUDAFED PE ® Pressure+Pain
50580-547-252024-01-30C16284748780-11030e365-0055-111a-e063-dadaa90a10e2SUDAFED PE ® Pressure+Pain
50580-547-732024-01-30C16284748780-11030e365-0055-111a-e063-dadaa90a10e2SUDAFED PE ® Pressure+Pain

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-547-25SUDAFED PE Pressure Plus Pain2 in 1 CARTONTABLET, FILM COATED215
50580-547-25SUDAFED PE Pressure Plus Pain12 in 1 BLISTER PACKTABLET, FILM COATED1215
50580-547-73SUDAFED PE Pressure Plus Pain2 in 1 CARTONTABLET, FILM COATED215
50580-547-73SUDAFED PE Pressure Plus Pain12 in 1 BLISTER PACKTABLET, FILM COATED1215

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-547-25EA - Each50580-547b3b25d88-3b75-466c-a7f0-b08a4e2194b712015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
acetaminophenACTIVE INGREDIENT362O9ITL9DSUDAFED PE PRESSURE PLUS PAIN (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
phenylephrine hydrochlorideACTIVE INGREDIENT04JA59TNSJSUDAFED PE PRESSURE PLUS PAIN (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
acetaminophenACTIVE MOIETY362O9ITL9DSUDAFED PE PRESSURE PLUS PAIN (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
phenylephrineACTIVE MOIETY1WS297W6MVSUDAFED PE PRESSURE PLUS PAIN (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
aluminum oxideINACTIVE INGREDIENTLMI26O6933SUDAFED PE PRESSURE PLUS PAIN (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
carnauba waxINACTIVE INGREDIENTR12CBM0EIZSUDAFED PE PRESSURE PLUS PAIN (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61USUDAFED PE PRESSURE PLUS PAIN (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
FD&C Yellow no. 6INACTIVE INGREDIENTH77VEI93A8SUDAFED PE PRESSURE PLUS PAIN (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
hypromellosesINACTIVE INGREDIENT3NXW29V3WOSUDAFED PE PRESSURE PLUS PAIN (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
magnesium stearateINACTIVE INGREDIENT70097M6I30SUDAFED PE PRESSURE PLUS PAIN (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ASUDAFED PE PRESSURE PLUS PAIN (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HSUDAFED PE PRESSURE PLUS PAIN (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
powdered celluloseINACTIVE INGREDIENTSMD1X3XO9MSUDAFED PE PRESSURE PLUS PAIN (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
sodium starch glycolate type a potatoINACTIVE INGREDIENT5856J3G2A2SUDAFED PE PRESSURE PLUS PAIN (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
starch, cornINACTIVE INGREDIENTO8232NY3SJSUDAFED PE PRESSURE PLUS PAIN (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPSUDAFED PE PRESSURE PLUS PAIN (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-547SUDAFED PE PRESSURE PLUS PAIN (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [KENVUE BRANDS LLC]15Current NDC, Legacy NDC, 4 package rows20241109_8538c291-9ce9-4866-b268-f4cbdb52f5bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046378acetaminophen 325 MG / phenylephrine HCl 5 MG Oral TabletPSN8538c291-9ce9-4866-b268-f4cbdb52f5bd15
1046378acetaminophen 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD8538c291-9ce9-4866-b268-f4cbdb52f5bd15
1046378APAP 325 MG / phenylephrine hydrochloride 5 MG Oral TabletSY8538c291-9ce9-4866-b268-f4cbdb52f5bd15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-547-25505800547252 BLISTER PACK in 1 CARTON (50580-547-25) / 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2012-07-010000-00-00NoNoCurrent
50580-547-73505800547732 BLISTER PACK in 1 CARTON (50580-547-73) > 12 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack2018-12-210000-00-00NoNoCurrent