Guaifenesin and Dextromethorphan Oral Solution

Product NDC: 0904-6980
11-digit product format: 009046980
Labeler code: 0904
Product ID: 0904-6980_d35bd4cf-bc58-856a-e053-2995a90a5d11
Type: HUMAN OTC DRUG
Nonproprietary name: Guaifenesin Dextromethorphan hydrobromide Oral Solution
Dosage form: SOLUTION
Route: ORAL
Labeler: Major Pharmaceuticals
Application: part341
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2019-09-20
Marketing end: 0000-00-00
Substance: GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength: 200 mg/10mL; mg/10mL
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0904-6980-72	2022-09-23	C162847	48780-1	e4f33bdf-ac2e-d8a0-e053-dadaa90a6e4e	9247ea9f-3df1-ef4c-e053-2995a90aab15
0904-6980-72	2022-07-29	C162847	48780-1	e4f33bdf-ac2e-d8a0-e053-dadaa90a6e4e	9247ea9f-3df1-ef4c-e053-2995a90aab15

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6980-72	ML - Milliliter	0904-6980	2f347743-4687-4407-8145-03a168ab2cf6	1	2019-10-07

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
495W7451VQ	GUAIFENESIN	93-14-1	GUAIFENESIN
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-6980-72	00904698072	10 TRAY in 1 CARTON (0904-6980-72) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE	10 tray	2019-09-20	0000-00-00	No	No	Current