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
Ingredient	Strength
PHENYLEPHRINE HYDROCHLORIDE	2.5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
04JA59TNSJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
692479	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
4dfd46e4-b9f9-464d-aa47-e8fa9e526a5d	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
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
42f3c020-f1b3-89bc-7bdc-e1f10e680485	Product name	1	20140508
e949165d-714d-e548-2b76-0cb5def16f30	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50580-784-04	Childrens Sudafed PENASAL DECONGESTANT	1 in 1 CARTON	SOLUTION	1		11
50580-784-04	Childrens Sudafed PENASAL DECONGESTANT	118 mL in 1 BOTTLE	SOLUTION	118		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50580-784-04	ML - Milliliter	50580-784	fc782f1b-f268-49e0-baa7-c76b72f6d059	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Phenylephrine hydrochloride	ACTIVE INGREDIENT	04JA59TNSJ	CHILDRENS SUDAFED PE NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	3
phenylephrine	ACTIVE MOIETY	1WS297W6MV	CHILDRENS SUDAFED PE NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	3
anhydrous citric acid	INACTIVE INGREDIENT	XF417D3PSL	CHILDRENS SUDAFED PE NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	3
carboxymethylcellulose sodium, unspecified form	INACTIVE INGREDIENT	K679OBS311	CHILDRENS SUDAFED PE NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	3
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	CHILDRENS SUDAFED PE NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	3
FD&C red No. 40	INACTIVE INGREDIENT	WZB9127XOA	CHILDRENS SUDAFED PE NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	3
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	CHILDRENS SUDAFED PE NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	3
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	CHILDRENS SUDAFED PE NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	3
sodium citrate	INACTIVE INGREDIENT	1Q73Q2JULR	CHILDRENS SUDAFED PE NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	3
sorbitol	INACTIVE INGREDIENT	506T60A25R	CHILDRENS SUDAFED PE NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	3
sucralose	INACTIVE INGREDIENT	96K6UQ3ZD4	CHILDRENS SUDAFED PE NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION]	3
water	INACTIVE INGREDIENT	059QF0KO0R	CHILDRENS 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
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50580-784	CHILDRENS SUDAFED PE NASAL DECONGESTANT (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION [KENVUE BRANDS LLC]	11	Current NDC, Legacy NDC, 2 package rows	20241115_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 179 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mucus Relief DM	MUCUS RELIEF DM	TopCo Associates, LLC	71674a9b-89ed-43d1-aadb-b9311fdfbdf9	2022-06-07	Warnings	Exact identifier application number: M012
Daytime Nighttime Cold and Flu Relief Combo Pack	DAYTIME NIGHTTIME COLD AND FLU	Allegiant Health	fa7ed5db-4da7-46b4-a08d-1d79cb7a5674	2022-05-19	Warnings	Exact identifier application number: M012
Mucus Relief DM Immediate Release	MUCUS RELIEF DM	Good Sense	26a199bf-57e5-4f36-b40c-83a1187e4870	2022-05-18	Warnings	Exact identifier application number: M012
Mucus Relief DM Immediate Release	MUCUS RELIEF DM	Allegiant Health	731f8608-ad5b-491e-a4d4-2bb0c423fed5	2022-05-18	Warnings	Exact identifier application number: M012
Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL	OPMX LLC	b3c229a4-c772-70fb-e053-2a95a90a72db	2022-03-11	Warnings	Exact identifier application number: M012
Allergy Relief	CHLORPHENIRAMINE MALEATE	Good Sense	f88e2654-8e97-4cf6-9c36-01aeb51a9102	2021-11-30	Warnings	Exact identifier application number: M012
Cold Medicine	COLD MEDICINE	Allegiant Health	443fbc44-2c33-4316-ad31-dcc5a5aa8f52	2021-11-23	Warnings	Exact identifier application number: M012
Decongestant PE Non Drowsy	PHENYLEPHRINE HCL	Allegiant Health	7a3098b4-381c-4f32-97a7-87b53fd64428	2021-06-16	Warnings	Exact identifier application number: M012
Mucus Relief Immediate Release	GUAIFENESIN 400MG	Good Sense	e7c68746-7ec0-46cf-b4a3-174fab819b5e	2021-05-05	Warnings	Exact identifier application number: M012
Mucus Relief Immediate Release	GUAIFENESIN 400MG	TopCo Associates, LLC	7d91c6ab-d161-42b9-b353-0aa8f59619f8	2021-01-21	Warnings	Exact identifier application number: M012
Daytime Cold and Flu	ACETAMINOPHEN 325MG/ DEXTROMETHORPHAN HBR 10MG/ PHENYLEPHRINE HCL 5MG	Allegiant Health	bed5f9dc-45ea-4e90-86c6-86599b6f3861	2020-11-16	Warnings	Exact identifier application number: M012
Nighttime Cold and Flu Relief	ACETAMINOPHEN	Allegiant Health	b97126d7-847d-483e-b3d1-e2b61ab1743f	2020-11-11	Warnings	Exact identifier application number: M012
Cold and Allergy	PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE	Allegiant Health	7af63769-fa56-4f1f-a2ad-5b4c108c8e4f	2019-12-12	Warnings	Exact identifier application number: M012
Mucus Relief Immediate Release	GUAIFENESIN	Allegiant Health	221d64a2-b8c7-435a-aae4-fb58fd38108f	2019-03-26	Warnings	Exact identifier application number: M012
Sleep Tabs For Nighttime use	DIPHENHYDRAMINE HCL TABLETS	Allegiant Health	566e40b1-e9d7-44e4-b971-eef2b7cf0a7d	2018-12-26	Warnings	Exact identifier application number: M012
Allergy	CHLORPHENIRAMINE MALEATE	Allegiant Health	4305ad50-d2a5-4d3e-9d92-cbf26e856a16	2018-12-26	Warnings	Exact identifier application number: M012
Sleep Aid	DIPHENHYDRAMINE HCL 25 MG	Allegiant Health	dbbc535f-515a-4d9b-b799-34e60f5230bb	2018-12-21	Warnings	Exact identifier application number: M012
Allergy	DIPHENHYDRAMINE HCL	Allegiant Health	c2823bad-540f-4662-8dcc-58e9f0d94efb	2018-11-07	Warnings	Exact identifier application number: M012
Nasal Decongestant PE Maximum Strength Non-Drowsy	PHENYLEPHRINE 10 MG	Allegiant Health	7aef00df-816a-4ea2-a2ad-beed66dd2fe4	2018-11-07	Warnings	Exact identifier application number: M012
DEXTROMETHORPHAN HYDROBROMIDE, Guaifenesin, and PHENYLEPHRINE HYDROCHLORIDE	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Westminster Pharmaceuticals, LLC	a58bfb14-28f9-4425-a5a5-aaff4847c979	2018-03-14	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
692479	phenylephrine HCl 2.5 MG in 5 mL Oral Solution	PSN	4dfd46e4-b9f9-464d-aa47-e8fa9e526a5d	11
692479	phenylephrine hydrochloride 0.5 MG/ML Oral Solution	SCD	4dfd46e4-b9f9-464d-aa47-e8fa9e526a5d	11
692479	phenylephrine hydrochloride 2.5 MG per 5 ML Oral Solution	SY	4dfd46e4-b9f9-464d-aa47-e8fa9e526a5d	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50580-784-04	50580078404	1 BOTTLE in 1 CARTON (50580-784-04) / 118 mL in 1 BOTTLE	1 bottle	2008-10-01	0000-00-00	No	No	Current