Childrens Mucinex Stuffy Nose and Cold

Product NDC: 63824-284
11-digit product format: 638240284
Labeler code: 63824
Product ID: 63824-284_61dc7407-eefc-41a3-8c90-75a864a67626
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin and Phenylephrine Hydrochloride
Dosage form: SOLUTION
Route: ORAL
Labeler: RB Health (US) LLC
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2012-07-13
Marketing end: 2024-02-15
Substance: GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 100 mg/5mL; mg/5mL
Pharmacologic classes: Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63824-284-64	2022-03-04	C162847	48780-1	9d75b9cf-eab9-f424-e053-dadaa90a57ce	8d0f2a01-f58b-43c0-b3f6-a88f9eb39c52
63824-284-64	2020-01-31	C162847	48780-1	9d75b9cf-eab9-f424-e053-dadaa90a57ce	8d0f2a01-f58b-43c0-b3f6-a88f9eb39c52

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63824-284-64	ML - Milliliter	63824-284	304a0a20-c926-4caa-9de1-dccc4ea24264	1	2014-04-03

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63824-284-64	63824028464	1 BOTTLE in 1 CARTON (63824-284-64) > 118 mL in 1 BOTTLE	1 bottle	2012-07-13	2024-02-15	No	No	Current