Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl

Product NDC: 55629-015
11-digit product format: 556290015
Labeler code: 55629
Product ID: 55629-015_08fa64e1-619b-452e-9e2e-a6569daae95a
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: ONE2ZEE LIMITED LIABILITY COMPANY
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2021-03-01
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength: 325 mg/1; mg/1; 1/1; 1/1
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4fe95224-f543-4dbb-9445-8cca122b48c8	Product name	1	20150609
e8718272-64cb-4436-969b-176c3067c8f4	Product name	1	20150609
106ff02a-57e1-4c4c-a307-fd582ff4e311	Product name	1	20150212

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55629-015-01	2023-01-30	C162847	48780-1	f386c649-d452-0266-e053-dadaa90a7c1a	DayTime Severe Cold and Flu capsule, liquid filled (Acetaminophen 325mg, Guaifenesin 200mg, Dextromethorphan HBr 10mg, Phenylephrine HCl 5mg)

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55629-015-01	Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl	48 in 1 CARTON	CAPSULE, LIQUID FILLED	48		1
55629-015-02	Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl	300 in 1 POUCH	CAPSULE, LIQUID FILLED	300		1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55629-015	ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL CAPSULE, LIQUID FILLED [ONE2ZEE LIMITED LIABILITY COMPANY]	1	Legacy NDC, 2 package rows	20210301_de4d25ea-6f0e-49d8-b2ad-fdccf95f54ca.zip

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
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1656815	acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG Oral Capsule	PSN	de4d25ea-6f0e-49d8-b2ad-fdccf95f54ca	1
1656815	acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG Oral Capsule	SCD	de4d25ea-6f0e-49d8-b2ad-fdccf95f54ca	1
1656815	APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / Guaifenesin 200 MG / Phenylephrine Hydrochloride 5 MG Oral Capsule	SY	de4d25ea-6f0e-49d8-b2ad-fdccf95f54ca	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55629-015-01	55629001501	48 POUCH in 1 CARTON (55629-015-01) > 300 CAPSULE, LIQUID FILLED in 1 POUCH (55629-015-02)	48 pouch	2021-03-01	0000-00-00	No	No	Current
55629-015-02	55629001502	300 in 1 POUCH						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Acetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl	ONE2ZEE LIMITED LIABILITY COMPANY \| Medgel Private Limited	2021-02-28	HUMAN OTC DRUG LABEL	1