FDA.reportPublic FDA data

Childrens Sudafed PE

Product NDC
50580-784
11-digit product format
505800784
Labeler code
50580
Product ID
50580-784_23506802-1f31-c967-e063-6394a90a2e7f
Type
HUMAN OTC DRUG
Nonproprietary name
Phenylephrine hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Kenvue Brands LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-10-01
Substance
PHENYLEPHRINE HYDROCHLORIDE
Active strength
2.5 mg/5mL
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

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
Childrens Sudafed PE
Brand name suffix
NASAL DECONGESTANT
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE2.5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
692479Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4dfd46e4-b9f9-464d-aa47-e8fa9e526a5dAvailable on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-784-04Childrens Sudafed PENASAL DECONGESTANT1 in 1 CARTONSOLUTION111
50580-784-04Childrens Sudafed PENASAL DECONGESTANT118 mL in 1 BOTTLESOLUTION11811

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-784-04ML - Milliliter50580-784fc782f1b-f268-49e0-baa7-c76b72f6d05912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Phenylephrine hydrochlorideACTIVE INGREDIENT04JA59TNSJCHILDRENS SUDAFED PE NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]3
phenylephrineACTIVE MOIETY1WS297W6MVCHILDRENS SUDAFED PE NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]3
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLCHILDRENS SUDAFED PE NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]3
carboxymethylcellulose sodium, unspecified formINACTIVE INGREDIENTK679OBS311CHILDRENS SUDAFED PE NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]3
edetate disodiumINACTIVE INGREDIENT7FLD91C86KCHILDRENS SUDAFED PE NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]3
FD&C red No. 40INACTIVE INGREDIENTWZB9127XOACHILDRENS SUDAFED PE NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]3
glycerinINACTIVE INGREDIENTPDC6A3C0OXCHILDRENS SUDAFED PE NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]3
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUCHILDRENS SUDAFED PE NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]3
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRCHILDRENS SUDAFED PE NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]3
sorbitolINACTIVE INGREDIENT506T60A25RCHILDRENS SUDAFED PE NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]3
sucraloseINACTIVE INGREDIENT96K6UQ3ZD4CHILDRENS SUDAFED PE NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]3
waterINACTIVE INGREDIENT059QF0KO0RCHILDRENS SUDAFED PE NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-784CHILDRENS SUDAFED PE NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [KENVUE BRANDS LLC]11Current NDC, Legacy NDC, 2 package rows20241115_4dfd46e4-b9f9-464d-aa47-e8fa9e526a5d.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 117 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Severe ColdACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIcf2dd1fb-1d5b-428e-8c9a-a46dbd7cb6452025-05-07WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRHaleon US Holdings LLC2b962d87-6ff5-4c0f-8504-e5b61c9406122025-05-05WarningsExact identifier
application number: M012
Cough and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE LIQUIDCVS2d13564a-e8d1-c357-e063-6394a90ad90e2025-05-02WarningsExact identifier
application number: M012
SUDAFED OM Sinus Severe No Drip Nasal Mist with Cooling MentholOXYMETAZOLINE HYDROCHLORIDEKenvue Brands LLC33fe0e49-3de5-8afd-e063-6294a90a0ad52025-05-02WarningsExact identifier
application number: M012
Daytime and Nighttime High Blood Pressure Cold and Flu LiquidACETAMINOPHEN, DEXTROMETHORPHAN HBR AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS Pharmacy, Inc.2d13964a-8cc4-f3dc-e063-6394a90aa1052025-05-02WarningsExact identifier
application number: M012
DIPHENHYDRAMINE HCL 12.5 MG PER 5 MLDIPHENHYDRAMINE HCL 12.5 MG PER 5 MLAARNA USA INC.32c26835-f54e-d7e5-e063-6294a90ae1c02025-04-30WarningsExact identifier
application number: M012
SUDAFED OM Sinus Severe No Drip Nasal MistOXYMETAZOLINE HYDROCHLORIDEKenvue Brands LLC33e6239b-364a-0e62-e063-6294a90a50472025-04-29WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLCVS Pharmacy8296049c-72fc-4200-9d45-c8e377314cf22025-04-29WarningsExact identifier
application number: M012
NIGHTTIME COLD AND FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATEAurohealth LLC70e1bd25-c32e-491f-b383-91d6f74957a02025-04-28WarningsExact identifier
application number: M012
Childrens Allergy Relief Dye FreeDIPHENHYDRAMINE HCLCVS Pharmacy70914691-220c-4fce-9ee1-61a51e8864bc2025-04-26WarningsExact identifier
application number: M012
Pseudoephedrine HydrochloridePSEUDOEPHEDRINE HYDROCHLORIDEA-S Medication Solutions810ce630-41be-4e15-b64a-d70f63abaf622025-04-24WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDEH E B5f945975-224f-43eb-b129-a61e3b25c4bb2025-04-22WarningsExact identifier
application number: M012
Walgreens Severe Honey Lemon Throat DropsMENTHOLWalgreens334a9348-2a44-5c94-e063-6394a90ae9562025-04-21WarningsExact identifier
application number: M012
meijer Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEMeijer, Inc.1bd85bc3-e600-583d-e063-6294a90a7be12025-04-18WarningsExact identifier
application number: M012
Daytime Nighttime Ultra ConcentratedDAYTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEKROGER COMPANY2be4a37b-44e1-8a8e-e063-6394a90a26a92025-04-17WarningsExact identifier
application number: M012
good neighbor pharmacy childrens cold and coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEAmerisource Bergencde0fd43-771f-4528-bad2-5727efec52502025-04-17WarningsExact identifier
application number: M012
MUCUS RELIEFGUAIFENESIN 400 MGPioneer Life Sciences, LLC729ab412-f30b-4ad1-9d8f-1a5e1c48b1182025-04-16WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.9382c976-3067-4923-a38f-101d1c481e972025-04-11WarningsExact identifier
application number: M012
Daytime Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HCL LIQUID FILLED CAPSULESWalmart Inc.263d31c8-bdc2-a289-e063-6394a90a4aaa2025-04-10WarningsExact identifier
application number: M012
CVS Wild Cherry Throat DropPECTINCVS31f4b641-e9c0-786e-e063-6394a90aa2532025-04-04WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
692479phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSN4dfd46e4-b9f9-464d-aa47-e8fa9e526a5d11
692479phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD4dfd46e4-b9f9-464d-aa47-e8fa9e526a5d11
692479phenylephrine hydrochloride 2.5 MG per 5 ML Oral SolutionSY4dfd46e4-b9f9-464d-aa47-e8fa9e526a5d11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-784-04505800784041 BOTTLE in 1 CARTON (50580-784-04) / 118 mL in 1 BOTTLE1 bottle2008-10-010000-00-00NoNoCurrent