FDA.reportPublic FDA data

SUDAFED PE SINUS CONGESTION

Product NDC
50580-239
11-digit product format
505800239
Labeler code
50580
Product ID
50580-239_216dcbdd-8eff-4427-e063-6294a90aed52
Type
HUMAN OTC DRUG
Nonproprietary name
diphenhydramine hydrochloride and phenylephrine hydrochloride
Dosage form
KIT
Labeler
Kenvue Brands LLC
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-06-17
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
SUDAFED PE SINUS CONGESTION
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049182Internal RxNorm lookup
1052767Internal RxNorm lookup
1052928Internal RxNorm lookup
2639176Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a38fdfb8-db89-487f-9b68-aa9152b91f5fAvailable 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
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50580-239-012024-02-01C16284748780-11030e365-3d2f-111a-e063-dadaa90a10e2SUDAFED PE SINUS CONGESTION
50580-239-012024-01-30C16284748780-11030e365-3d2f-111a-e063-dadaa90a10e2SUDAFED PE SINUS CONGESTION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50580-239-01SUDAFED PE SINUS CONGESTION1 in 1 PACKAGEKIT15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50580-239-01EA - Each50580-239c73d5821-9a01-4318-832e-0ce47494943812020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50580-239SUDAFED PE SINUS CONGESTION (DIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) KIT [KENVUE BRANDS LLC]5Current NDC, Legacy NDC, 1 package rows20241109_a38fdfb8-db89-487f-9b68-aa9152b91f5f.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 121 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Halls Sugar Free CherryMENTHOLMondelez Global LLCea8dfe96-f6a4-4172-bf9e-ae3cf606ff502025-02-14WarningsExact identifier
application number: M012
Halls Sugar Free WatermelonMENTHOLMondelez Global LLCc4c090ca-f083-74e0-e053-2a95a90a9d602025-02-14WarningsExact identifier
application number: M012
Tukol Max ActionOXYMETAZOLINE HYDROCHLORIDEGenomma Lab USA73358103-43dc-4b11-9c89-9a6ba45bf1af2025-02-14WarningsExact identifier
application number: M012
Maximum Strength Mucus ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLChain Drug Marketing Association Inc.6c4e867b-24b9-4525-9fab-10f1e7910b132025-02-13WarningsExact identifier
application number: M012
DAYTIME- NIGHTTIME COLD AND FLUDAYTIME NIGHTTIME COLD AND FLUTARGET CORP9def204a-ee1e-6868-e053-2995a90a76b82025-02-13WarningsExact identifier
application number: M012
Daytime Cold and Flu and Nigttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEBETTER LIVING BRANDS LLC.f2c11b63-278f-64de-e053-2995a90a5aae2025-02-12WarningsExact identifier
application number: M012
Daytime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLBETTER LIVING BRANDS LLC.f29c604a-271d-a702-e053-2a95a90a34272025-02-12WarningsExact identifier
application number: M012
Nighttime cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEBETTER LIVING BRANDS LLC.f2c01090-645c-1efe-e053-2995a90a7df52025-02-12WarningsExact identifier
application number: M012
AXIV DayTimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEVIVUNT PHARMA LLC131b1f17-cd86-f9b3-e063-6294a90a30282025-02-12WarningsExact identifier
application number: M012
Maximum Strength Mucus Relief DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINTopco Associates, LLC17d0dbc7-c8c2-7917-e063-6394a90a42af2025-02-12WarningsExact identifier
application number: M012
DAYTIME COLD AND FLUDEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEKroger Companybc00bbf8-52bb-fa75-e053-2a95a90a94062025-02-11WarningsExact identifier
application number: M012
Daytime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI 325, 10, 5 MG SOFTGELSTIME CAP LABORATORIES, INC.fd24653e-c4fa-3c09-e053-6394a90aaa9e2025-02-10WarningsExact identifier
application number: M012
Daytime Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI, DOXYLAMINE SUCCINATE 325, 10/15, 5, 6.25 MG SOFTGELSTIME CAP LABORATORIES INC.fd81dd4b-9617-f4c1-e053-6394a90a5e722025-02-10WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEDOLGENCORP, LLCbe2207b7-b8f8-7fba-e053-2a95a90abd162025-02-10WarningsExact identifier
application number: M012
NIGHTTIME COLD AND FLUDEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, DOXYLAMINE SUCCINATEKroger Companybc0115a3-5322-855d-e053-2995a90aba272025-02-10WarningsExact identifier
application number: M012
Day time high blood pressure cold and fluACETAMINOPHEN DEXTROMETHORPHAN HBRCamber Consumer Care09fbd872-0970-4864-9308-4a7b859839202025-02-10WarningsExact identifier
application number: M012
Cough DropsMENTHOLThe Kroger COf05e11ce-c908-acbc-e053-2a95a90a584e2025-02-09WarningsExact identifier
application number: M012
Cough DropsMENTHOLThe Kroger COf035c499-cda6-fadf-e053-2995a90af4572025-02-09WarningsExact identifier
application number: M012
Cough DropsMENTHOLThe Kroger COf6d977ce-bbca-f1cc-e053-6394a90acc962025-02-09WarningsExact identifier
application number: M012
Cough DropsMENTHOLThe Kroger COf6da36d3-496d-2336-e053-6394a90a0f832025-02-09WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2639176{1 (diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Oral Tablet) / 1 (phenylephrine hydrochloride 10 MG Oral Tablet) } PackGPCKa38fdfb8-db89-487f-9b68-aa9152b91f5f5
26391761 daytime (phenylephrine hydrochloride 10 MG Oral Tablet) / 1 nighttime (diphenhydrAMINE hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Oral Tablet) PackPSNa38fdfb8-db89-487f-9b68-aa9152b91f5f5
1052928diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Oral TabletPSNa38fdfb8-db89-487f-9b68-aa9152b91f5f5
1049182phenylephrine HCl 10 MG Oral TabletPSNa38fdfb8-db89-487f-9b68-aa9152b91f5f5
1052767SUDAFED PE 10 MG Oral TabletPSNa38fdfb8-db89-487f-9b68-aa9152b91f5f5
1052767phenylephrine hydrochloride 10 MG Oral Tablet [Sudafed PE]SBDa38fdfb8-db89-487f-9b68-aa9152b91f5f5
1052928diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Oral TabletSCDa38fdfb8-db89-487f-9b68-aa9152b91f5f5
1049182phenylephrine hydrochloride 10 MG Oral TabletSCDa38fdfb8-db89-487f-9b68-aa9152b91f5f5
26391761 daytime (phenylephrine hydrochloride 10 MG Oral Tablet) / 1 nighttime (diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Oral Tablet) PackSYa38fdfb8-db89-487f-9b68-aa9152b91f5f5
1052767Sudafed PE 10 MG Oral TabletSYa38fdfb8-db89-487f-9b68-aa9152b91f5f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50580-239-01505800239011 KIT in 1 PACKAGE (50580-239-01) * 2 BLISTER PACK in 1 CARTON / 6 TABLET, FILM COATED in 1 BLISTER PACK * 2 BLISTER PACK in 1 CARTON / 4 TABLET, FILM COATED in 1 BLISTER PACK1 kit2019-06-170000-00-00NoNoCurrent