FDA.reportPublic FDA data

Childrens SUDAFED PE Cold plus Cough

Product NDC
50580-785
11-digit product format
505800785
Labeler code
50580
Product ID
50580-785_23508e92-0823-8827-e063-6394a90aeb9d
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan hydrobromide and Phenylephrine hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Kenvue Brands LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-10-01
Substance
DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
5; 2.5 mg/5mL; mg/5mL
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [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 Cold plus Cough
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE5 mg/5mL
PHENYLEPHRINE HYDROCHLORIDE2.5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9D2RTI9KYHInternal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1544873Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
20e45243-3989-413a-bcf1-49d754ff2e44Available 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
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-785-04Childrens SUDAFED PE Cold plus Cough1 in 1 CARTONSOLUTION112
50580-785-04Childrens SUDAFED PE Cold plus Cough118 mL in 1 BOTTLESOLUTION11812

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-785-04ML - Milliliter50580-78596afadcd-980a-4ce1-8594-c9260351279d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Dextromethorphan hydrobromideACTIVE INGREDIENT9D2RTI9KYHCHILDRENS SUDAFED PE COLD AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
Phenylephrine hydrochlorideACTIVE INGREDIENT04JA59TNSJCHILDRENS SUDAFED PE COLD AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
dextromethorphanACTIVE MOIETY7355X3ROTSCHILDRENS SUDAFED PE COLD AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
phenylephrineACTIVE MOIETY1WS297W6MVCHILDRENS SUDAFED PE COLD AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLCHILDRENS SUDAFED PE COLD AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
carboxymethylcellulose sodiumINACTIVE INGREDIENTK679OBS311CHILDRENS SUDAFED PE COLD AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
edetate disodiumINACTIVE INGREDIENT7FLD91C86KCHILDRENS SUDAFED PE COLD AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
FD&C blue NO. 1INACTIVE INGREDIENTH3R47K3TBDCHILDRENS SUDAFED PE COLD AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
FD&C red NO. 40INACTIVE INGREDIENTWZB9127XOACHILDRENS SUDAFED PE COLD AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
glycerinINACTIVE INGREDIENTPDC6A3C0OXCHILDRENS SUDAFED PE COLD AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUCHILDRENS SUDAFED PE COLD AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRCHILDRENS SUDAFED PE COLD AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
sorbitolINACTIVE INGREDIENT506T60A25RCHILDRENS SUDAFED PE COLD AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
sucraloseINACTIVE INGREDIENT96K6UQ3ZD4CHILDRENS SUDAFED PE COLD AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2
waterINACTIVE INGREDIENT059QF0KO0RCHILDRENS SUDAFED PE COLD AND COUGH (DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [MCNEIL CONSUMER HEALTHCARE DIV. MCNEIL-PPC, INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-785CHILDRENS SUDAFED PE COLD PLUS COUGH (DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [KENVUE BRANDS LLC]12Current NDC, Legacy NDC, 2 package rows20241115_20e45243-3989-413a-bcf1-49d754ff2e44.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 81 of 177 · 3,534 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alka-Seltzer Plus Maximum Strength Cold and Cough Power Max GelsACETAMINOPHEN, CHLORPHENIRAMINE MALAEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.51dec468-fbb2-3489-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and NightASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.d7711cd6-5058-548d-e053-2a95a90ac54d2025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold and Flu PowerFast FizzCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.a2f0285b-8550-fd26-e053-2995a90ab6152025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cold Day and Night PowerMax gelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.f6c73f61-f4fc-377f-e053-6294a90a37972025-12-04WarningsExact identifier
application number: M012
Alka Seltzer Plus Maximum Strength Cough Chest Congestion PowerFast FizzDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINBayer Healthcare LLC.a32e2a5e-9aa0-4e7c-e053-2995a90a31902025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cold Day and Night PowerMax gelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.e2877488-3539-cba2-e053-2995a90a60052025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cough and Sore Throat FizzyChewsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.14951faa-9476-6f29-e063-6394a90a14c72025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cough Mucus and Congestion Liquid GelsALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTIONBayer HealthCare LLC.0c120569-622d-3a23-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cold and Flu FizzyChewsCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.149330be-24bd-b4a4-e063-6394a90a90072025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cough Mucus and Congestion Day and NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE, GUAIFENESINBayer HealthCare LLC.5278a128-41ec-4494-e054-00144ff8d46c2025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cold Orange ZestASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.53188c41-3f13-311b-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cold Day and NightASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.75894849-a0ba-57be-e053-2a91aa0a049a2025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cold Sparkling OriginalASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.531ab703-179a-70ad-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cold NightASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.7588ea67-68a9-4dc0-e053-2991aa0aa4712025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cold and CoughASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.75862805-2cfe-fb45-e053-2991aa0a14032025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Day Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.5172dc01-4e7f-3307-e054-00144ff8d46c2025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Cold and Cough Liquid GelsACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.20ae92d9-fbc6-5b7a-e063-6294a90a15c32025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.51c44970-06e5-082e-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.54236151-37db-0b5a-e054-00144ff88e882025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Severe Sinus Congestion and Cough Day and NightACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.52542774-fd05-640c-e054-00144ff8d46c2025-12-04WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1544873dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG in 5 mL Oral SolutionPSN20e45243-3989-413a-bcf1-49d754ff2e4412
1544873dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral SolutionSCD20e45243-3989-413a-bcf1-49d754ff2e4412
1544873dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG per 5 ML Oral SyrupSY20e45243-3989-413a-bcf1-49d754ff2e4412

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-785-04505800785041 BOTTLE in 1 CARTON (50580-785-04) / 118 mL in 1 BOTTLE1 bottle2008-10-010000-00-00NoNoCurrent