Childrens TYLENOL

Product NDC: 50580-194
11-digit product format: 505800194
Labeler code: 50580
Product ID: 50580-194_21d4a287-1f3b-ce36-e063-6294a90a1ef3
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen and Dextromethorphan Hydrobromide
Dosage form: SUSPENSION
Route: ORAL
Labeler: Kenvue Brands LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2017-06-26
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength: 160; 5 mg/5mL; mg/5mL
Pharmacologic classes: Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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 TYLENOL
Brand name suffix: COLD PLUS COUGH PLUS SORE THROAT
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	160 mg/5mL
DEXTROMETHORPHAN HYDROBROMIDE	5 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup
9D2RTI9KYH	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1370113	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
e83f7911-22b4-4ffc-8f49-68f6acd2ebf5	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50580-194-01	2024-02-01	C162847	48780-1	1030e365-51bf-111a-e063-dadaa90a10e2	Children's TYLENOL ® COLD + COUGH + SORE THROAT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50580-194-01	Childrens TYLENOLCOLD PLUS COUGH PLUS SORE THROAT	120 mL in 1 BOTTLE	SUSPENSION	120		6
50580-194-01	Childrens TYLENOLCOLD PLUS COUGH PLUS SORE THROAT	1 in 1 CARTON	SUSPENSION	1		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50580-194-01	ML - Milliliter	50580-194	66058b11-241c-4617-9589-0b6d20b852fb	1	2018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50580-194	CHILDRENS TYLENOL COLD PLUS COUGH PLUS SORE THROAT (ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE) SUSPENSION [KENVUE BRANDS LLC]	6	Current NDC, Legacy NDC, 2 package rows	20241109_e83f7911-22b4-4ffc-8f49-68f6acd2ebf5.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 96 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TexaClear Pain and Chest Congestion Relief	CHOLINE SALICYLATE,GUAIFENESIN	GM Pharmaceuticals, INC	672bc78a-2c71-4135-b64a-2b8c40ac688c	2025-10-13	Warnings	Exact identifier application number: M012
Vapor Stick	CAMPHOR/MENTHOL	Rejoice International Corp.	33d1fbf3-d33c-58b9-e063-6294a90ae098	2025-10-13	Warnings	Exact identifier application number: M012
Nitetime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	Meijer Distribution Inc	47f03174-6e91-4529-bbfa-ce58aa7b7d79	2025-10-13	Warnings	Exact identifier application number: M012
Nasal Decongestant Maximum Strength	PSEUDOEPHEDRINE HCL	CHAIN DRUG MARKETING ASSOCIATION INC	db81e32b-0cad-400b-8479-a3b51de92b12	2025-10-10	Warnings	Exact identifier application number: M012
Giltuss Childrens Cough and Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Gil Pharmaceutical Corp	852b77ae-a5ac-3ead-e053-2a91aa0a54bd	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Cough and Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	Gil Pharmaceutical Corp	8503c956-42a5-7684-e053-2991aa0adb27	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss HBP Cough and Chest Congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Gil Pharmaceutical Corp	852ceea2-d6a1-6de2-e053-2a91aa0ad50d	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Childrens Cough and Chest Congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Gil Pharmaceutical Corp	852d5f01-9289-5515-e053-2a91aa0acf32	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Diabetic Cough and Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Gil Pharmaceutical Corp	85183b38-ce2a-0e0e-e053-2991aa0a336f	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss MultiSymptom Cold and Flu	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Giltuss Pharmaceutical Corp	8518fd91-981e-de78-e053-2a91aa0afcb2	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Childrens MultiSymptom Cold and Flu	ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Giltuss Pharmaceutical Corp	852c8cd6-271f-0fa8-e053-2991aa0ab179	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Allergy Plus Cough and Congestion	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Gil Pharmaceutical Corp	85065cf3-386d-22d5-e053-2a91aa0a72da	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Honey Cough and Chest Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	Gil Pharmaceutical Corp	a8b2c847-25e9-8714-e053-2995a90a73ce	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Childrens Allergy Plus Cough and Congestion	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Gil Pharmaceutical Corp	852c5a57-7ee4-3c5c-e053-2a91aa0a1433	2025-10-09	Warnings	Exact identifier application number: M012
Childrens Giltuss Honey DM Cough	DEXTROMETHORPHAN HBR	Gil Pharmaceutical Corp	a8c5027f-9701-fb07-e053-2a95a90a6029	2025-10-09	Warnings	Exact identifier application number: M012
Childrens Giltuss Honey Cough and Chest Congestion	DEXTROMETHORPHAN HBR, GUAIFENESIN	Gil Pharmaceutical Corp	a8c052d8-fb9f-09f2-e053-2a95a90a37af	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss EX Expectorant	GUAIFENESIN	Gil Pharmaceutical Corp	a8c53c14-ba82-2c68-e053-2a95a90a9894	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Severe Sinus	OXYMETAZOLINE HCL	Gil Pharmaceutical Corp	ab7fae3b-1f7d-5d0f-e053-2a95a90a148e	2025-10-09	Warnings	Exact identifier application number: M012
Giltuss Honey DM Cough	DEXTROMETHORPHAN HBR	Gil Pharmaceutical Corp	a8c08532-1169-6603-e053-2a95a90a3484	2025-10-09	Warnings	Exact identifier application number: M012
Childrens Giltuss EX Expectorant	GUAIFENESIN	Gil Pharmaceutical Corp	a8c59e6d-c11c-2664-e053-2a95a90a8333	2025-10-09	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1370113	acetaminophen 160 MG / dextromethorphan HBr 5 MG in 5 mL Oral Suspension	PSN	e83f7911-22b4-4ffc-8f49-68f6acd2ebf5	6
1370113	acetaminophen 32 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Suspension	SCD	e83f7911-22b4-4ffc-8f49-68f6acd2ebf5	6
1370113	acetaminophen 160 MG / dextromethorphan HBr 5 MG per 5 ML Oral Suspension	SY	e83f7911-22b4-4ffc-8f49-68f6acd2ebf5	6
1370113	APAP 160 MG / dextromethorphan hydrobromide 5 MG per 5 ML Oral Suspension	SY	e83f7911-22b4-4ffc-8f49-68f6acd2ebf5	6
1370113	APAP 32 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML Oral Suspension	SY	e83f7911-22b4-4ffc-8f49-68f6acd2ebf5	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50580-194-01	50580019401	1 BOTTLE in 1 CARTON (50580-194-01) / 120 mL in 1 BOTTLE	1 bottle	2017-06-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Children's TYLENOL ® COLD + COUGH + SORE THROAT	Kenvue Brands LLC	2024-11-07	HUMAN OTC DRUG LABEL	6