Childrens Sudafed

Product NDC: 50580-536
11-digit product format: 505800536
Labeler code: 50580
Product ID: 50580-536_21732f4a-40b0-b486-e063-6394a90a1536
Type: HUMAN OTC DRUG
Nonproprietary name: Pseudoephedrine hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: Kenvue Brands LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2008-10-01
Substance: PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength: 15 mg/5mL
Pharmacologic classes: Adrenergic alpha-Agonists [MoA], alpha-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
Brand name suffix: Nasal Decongestant
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PSEUDOEPHEDRINE HYDROCHLORIDE	15 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6V9V2RYJ8N	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1049143	Internal RxNorm lookup
1049770	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
52e9307b-ad38-4f65-bb2f-4fa262e82010	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
0fdb98e2-b951-a1ce-5715-2b187ba500ef	Product name	4	20170718
e974e22d-8688-7d92-1e87-40c1079e170c	Product name	3	20151125
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
30c51294-7ae9-8007-7de6-58222684a0be	Product name	1	20140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66	Product name	1	20140508
70a83adc-6047-bbea-5a08-dfd304aa47d2	Product name	1	20140508
858ce051-9941-aafc-8c7c-44a8e0227463	Product name	1	20140508
b893258d-0942-3d8a-3411-056ea0788ff5	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50580-536-04	Childrens SudafedNasal Decongestant	118 mL in 1 BOTTLE	SOLUTION	118		9
50580-536-04	Childrens SudafedNasal Decongestant	1 in 1 CARTON	SOLUTION	1		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50580-536-04	ML - Milliliter	50580-536	05db4ca2-a3c2-4af3-8c25-4e35dc58b18c	1	2012-07-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50580-536	CHILDRENS SUDAFED NASAL DECONGESTANT (PSEUDOEPHEDRINE HYDROCHLORIDE) SOLUTION [KENVUE BRANDS LLC]	9	Current NDC, Legacy NDC, 2 package rows	20241109_52e9307b-ad38-4f65-bb2f-4fa262e82010.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 129 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mentholatum Cherry Vaporizing Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	The Mentholatum Company	de01225a-eabb-4972-bf3a-3e5a0e44abef	2024-12-17	Warnings	Exact identifier application number: M012
Rite Aid Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Rite Aid Corporation	198a666a-3f34-4e4f-89e8-ec7f412f00af	2024-12-17	Warnings	Exact identifier application number: M012
Equate Childrens Vaporizing	CAMPHOR, EUCALYPTUS OIL, MENTHOL	Wal-Mart Stores Inc	372e66a6-1f1f-4aa3-a2ed-d215fafee9b9	2024-12-17	Warnings	Exact identifier application number: M012
Caring Mill Chest Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	FSA Store Inc.	caa83419-c332-4b92-b151-22da2fa85289	2024-12-17	Warnings	Exact identifier application number: M012
Always Save Chest Congestion Relief GUAF	GUAIFENESIN	Valu Merch	9d81d88b-2db9-4891-942b-fecb1be961dd	2024-12-17	Warnings	Exact identifier application number: M012
Kroger EXTRA STRENGTH Acetaminophen PM Caplet	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	The Kroger Co.	24a75ffa-c2a7-71a9-e063-6394a90a0e25	2024-12-17	Warnings	Exact identifier application number: M012
Allergy 36ct, Caseys 4good	DIPHENHYDRAMINE HCL 25MG	Lil' Drug Store Products, Inc.	04b78b23-424d-9762-e063-6394a90a52e3	2024-12-16	Warnings	Exact identifier application number: M012
Sinus Relief, Caseys 4good	ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL CAPLET, FILM-COATED	Lil' Drug Store Products, Inc.	033837c0-fa68-a38d-e063-6394a90a9832	2024-12-16	Warnings	Exact identifier application number: M012
DayQuil Severe plus VapoCOOL Cold and Flu, Travel BASIX	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE	Lil' Drug Store Products, Inc.	cfab9b80-0580-4482-b6e3-0aab875b5797	2024-12-16	Warnings	Exact identifier application number: M012
Allergy Relief, 24-7 Lift by 7-Eleven	DIPHENHYDRAMINE HCL 25MG	Lil' Drug Store products, Inc.	04c9db9a-95ef-3a48-e063-6294a90a4e8e	2024-12-16	Warnings	Exact identifier application number: M012
Cold and Flu Daytime Severe, 24/7 Life	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL TABLET	Lil' Drug Store Products, Inc.	05cc7185-d49d-82a3-e063-6294a90a568e	2024-12-16	Warnings	Exact identifier application number: M012
Cold and Flu Nighttime Severe, 24-7 Life	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Lil' Drug Store products, Inc.	05d0410f-164e-e7ee-e063-6394a90a2aaa	2024-12-16	Warnings	Exact identifier application number: M012
tussin dm max daytime nighttime	DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFESESIN	CVS Pharmacy	6feaf29e-de06-4c94-912c-a76ea2cbd8c1	2024-12-16	Warnings	Exact identifier application number: M012
Leader Childrens Multi Symptom Cold	DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL	CARDINAL HEALTH 110, LLC. DBA LEADER	169ff9cf-fcf5-46a6-b460-259421f2ec07	2024-12-16	Warnings	Exact identifier application number: M012
Childrens Mucus and Cough Relief	DEXTROMETHORPHAN HBR, GUAIFENESIN	CARDINAL HEALTH 110, LLC. DBA LEADER	125eeb3d-0ee2-45bb-81c0-4ca699979886	2024-12-16	Warnings	Exact identifier application number: M012
Dextromethorphan HBr 15 mg Liquid Gels	DEXTROMETHORPHAN HBR	RUGBY LABORATORIES	cf3cc387-6642-43fd-999d-688fdaf65d4f	2024-12-14	Warnings	Exact identifier application number: M012
Allergy Relief Dye-Free Softgel	DIPHENHYDRAMINE HYDROCHLORIDE	CVS PHARMACY, INC	60b1bb79-3ed1-438b-a27f-f7fbc108d114	2024-12-14	Warnings	Exact identifier application number: M012
Rycontuss Cherry Flavor	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Okendpharma, Inc.	c91798fa-48ab-47a0-92da-4d44c2aafde0	2024-12-13	Warnings	Exact identifier application number: M012
Mentholatum Lavender Vaporizing Rub	CAMPHOR, EUCALYPTUS OIL, MENTHOL	The Mentholatum Company	6f208c05-617d-492a-a016-e9d6be3c971f	2024-12-13	Warnings	Exact identifier application number: M012
CVS Vapor Steam	CAMPHOR (SYNTHETIC)	CVS	49da2c40-afc5-5770-e054-00144ff88e88	2024-12-13	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6V9V2RYJ8N	PSEUDOEPHEDRINE HYDROCHLORIDE	345-78-8	PSEUDOEPHEDRINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1049143	pseudoephedrine HCl 15 MG in 5 mL Oral Solution	PSN	52e9307b-ad38-4f65-bb2f-4fa262e82010	9
1049770	SUDAFED 15 MG in 5 mL Oral Solution	PSN	52e9307b-ad38-4f65-bb2f-4fa262e82010	9
1049770	pseudoephedrine hydrochloride 3 MG/ML Oral Solution [Sudafed]	SBD	52e9307b-ad38-4f65-bb2f-4fa262e82010	9
1049143	pseudoephedrine hydrochloride 3 MG/ML Oral Solution	SCD	52e9307b-ad38-4f65-bb2f-4fa262e82010	9
1049143	pseudoephedrine hydrochloride 15 MG per 5 ML Oral Solution	SY	52e9307b-ad38-4f65-bb2f-4fa262e82010	9
1049770	Sudafed 15 MG per 5 ML Oral Solution	SY	52e9307b-ad38-4f65-bb2f-4fa262e82010	9
1049770	Sudafed 3 MG/ML Oral Solution	SY	52e9307b-ad38-4f65-bb2f-4fa262e82010	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50580-536-04	50580053604	1 BOTTLE in 1 CARTON (50580-536-04) / 118 mL in 1 BOTTLE	1 bottle	2008-10-01	0000-00-00	No	No	Current