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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
a38fdfb8-db89-487f-9b68-aa9152b91f5f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e4e263da-1c53-440f-bb80-b7a575843b5a	Product name	1	20260313
d2168cac-a261-415a-9c78-3522859fa720	Product name	3	20251124
05a8cdd1-eeb8-409e-b938-0778225eca7d	Product name	4	20250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9	Product name	8	20250220
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
f489e8f3-5c9e-4818-b539-a73587edcfc7	Product name	2	20240229
0f7ae452-206d-4fc4-868d-56fc47074084	Product name	1	20231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3df	Product name	2	20190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814	Product name	3	20150910
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50580-239-01	2024-02-01	C162847	48780-1	1030e365-3d2f-111a-e063-dadaa90a10e2	SUDAFED PE SINUS CONGESTION
50580-239-01	2024-01-30	C162847	48780-1	1030e365-3d2f-111a-e063-dadaa90a10e2	SUDAFED PE SINUS CONGESTION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50580-239-01	SUDAFED PE SINUS CONGESTION	1 in 1 PACKAGE	KIT	1		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50580-239-01	EA - Each	50580-239	c73d5821-9a01-4318-832e-0ce474949438	1	2020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50580-239	SUDAFED PE SINUS CONGESTION (DIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE) KIT [KENVUE BRANDS LLC]	5	Current NDC, Legacy NDC, 1 package rows	20241109_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 159 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Topcare childrens allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Topco Associates LLC	6b784cde-3152-4421-a825-dd1fc601aa7a	2024-07-17	Warnings	Exact identifier application number: M012
Mucus Relief Severe Congestion and Cough Maximum Strength	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Walgreens	4c6b6379-3a7f-4507-a792-7b69a7f3ba82	2024-07-17	Warnings	Exact identifier application number: M012
Mucus Relief Cold Flu Sore Throat Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	Walgreens	04defcf6-e20e-402b-b725-d9394a0146b1	2024-07-16	Warnings	Exact identifier application number: M012
basic care allergy relief	DIPHENHYDRAMINE HYDROCHLORIDE	Amazon.com Services LLC	7d237d37-21c7-476d-a8b7-d91ea1b472ee	2024-07-16	Warnings	Exact identifier application number: M012
Berkley and Jensen Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	BJWC	b52fc311-8853-4116-941b-8be35456abba	2024-07-16	Warnings	Exact identifier application number: M012
Mucus Relief All In One Daytime Nighttime Cold Flu Maximum Strength	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL PHENYLEPHRINE HCL	Walgreens	0b9a4438-7d13-484c-a614-2dedc24974dc	2024-07-16	Warnings	Exact identifier application number: M012
allergy	DIPHENHYDRAMINE HYDROCHLORIDE	Publix Super Markets Inc	23a98385-28cc-4fac-8c87-b3ced8106532	2024-07-16	Warnings	Exact identifier application number: M012
Walgreens Moisturizing Ultra Fine Mist with Aloe	0.05% OXYMETAZOLINE	Walgreens Company	aad01028-cbe0-4c10-adbc-d157bfa5af09	2024-07-16	Warnings	Exact identifier application number: M012
Basic Care severe cold and cough	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE	Amazon.com Services LLC	924bf427-b054-46af-b341-ff162946cd58	2024-07-15	Warnings	Exact identifier application number: M012
Maximum Strength Cold Tabs	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	JHK DBA American Safety & First Aid	e7d4fe9a-eb09-4266-90c9-290f61ce6ad0	2024-07-15	Warnings	Exact identifier application number: M012
ACTIDOM DA	CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE	ACTIPHARMA, LLC	7797c22e-ffeb-4798-9fb6-aa64cf077ba7	2024-07-15	Warnings	Exact identifier application number: M012
Nighttime severe cold and flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	TARGET CORPORATION	1cf3064d-4ddd-63b9-e063-6294a90aa547	2024-07-11	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL	TARGET CORPORATION	1ccbdb53-3f70-28da-e063-6394a90a9ae0	2024-07-09	Warnings	Exact identifier application number: M012
AXIV Allergy Relief	DIPHENHYDRAMINE HYDROCHLORIDE	VIVUNT PHARMA LLC	1cd2a6f1-31ad-e507-e063-6394a90aba58	2024-07-09	Warnings	Exact identifier application number: M012
Poly Hist Forte	DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE	Poly Pharmaceuticals, Inc.	8aa0015b-8fc1-7951-e053-2a95a90a8e72	2024-07-09	Warnings	Exact identifier application number: M012
DECONEX DMX	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Poly Pharmaceuticals, Inc.	8aab8e5c-1633-2e5a-e053-2a95a90adcc5	2024-07-09	Warnings	Exact identifier application number: M012
Deconex IR	GUAIFENESIN AND PHENYLEPHRINE HCL	Poly Pharmaceuticals, Inc.	4710095e-3dae-4a39-8a98-873012e1f003	2024-07-09	Warnings	Exact identifier application number: M012
Diabetic Tussin Sore Throat and Cough Cherry	BENZOCAINE AND DEXTROMETHORPHAN HBR	MEDTECH PRODUCTS INC	e9327079-e0fc-4c95-b1d5-bc1b74870c9b	2024-07-09	Warnings	Exact identifier application number: M012
nasal	OXYMETAZOLINE HYDROCHLORIDE	Rite Aid Corporation	fac859a4-e23a-4879-af6c-26368455506d	2024-07-05	Warnings	Exact identifier application number: M012
Severe Throat Drops	MENTHOL ICE	Target Corporation Inc.	1876b221-fa60-5269-e063-6394a90a6963	2024-07-04	Warnings	Exact identifier application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2639176	{1 (diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Oral Tablet) / 1 (phenylephrine hydrochloride 10 MG Oral Tablet) } Pack	GPCK	a38fdfb8-db89-487f-9b68-aa9152b91f5f	5
2639176	1 daytime (phenylephrine hydrochloride 10 MG Oral Tablet) / 1 nighttime (diphenhydrAMINE hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Oral Tablet) Pack	PSN	a38fdfb8-db89-487f-9b68-aa9152b91f5f	5
1052928	diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Oral Tablet	PSN	a38fdfb8-db89-487f-9b68-aa9152b91f5f	5
1049182	phenylephrine HCl 10 MG Oral Tablet	PSN	a38fdfb8-db89-487f-9b68-aa9152b91f5f	5
1052767	SUDAFED PE 10 MG Oral Tablet	PSN	a38fdfb8-db89-487f-9b68-aa9152b91f5f	5
1052767	phenylephrine hydrochloride 10 MG Oral Tablet [Sudafed PE]	SBD	a38fdfb8-db89-487f-9b68-aa9152b91f5f	5
1052928	diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Oral Tablet	SCD	a38fdfb8-db89-487f-9b68-aa9152b91f5f	5
1049182	phenylephrine hydrochloride 10 MG Oral Tablet	SCD	a38fdfb8-db89-487f-9b68-aa9152b91f5f	5
2639176	1 daytime (phenylephrine hydrochloride 10 MG Oral Tablet) / 1 nighttime (diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Oral Tablet) Pack	SY	a38fdfb8-db89-487f-9b68-aa9152b91f5f	5
1052767	Sudafed PE 10 MG Oral Tablet	SY	a38fdfb8-db89-487f-9b68-aa9152b91f5f	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50580-239-01	50580023901	1 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 PACK	1 kit	2019-06-17	0000-00-00	No	No	Current