Guaifenesin and Dextromethorphan Hydrobromide

Product NDC
63629-1155
11-digit product format
636291155
Labeler code
63629
Product ID
63629-1155_e5345fd4-7807-4304-a06a-1d02bf4a2d1e
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin and Dextromethorphan Hydrobromide
Dosage form
SYRUP
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2016-06-14
Marketing end
0000-00-00
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
10 mg/5mL; mg/5mL
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1155-1ML - Milliliter63629-1155f19518b2-dd10-4463-a7cb-ff80791c01fa12021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1155GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP [BRYANT RANCH PREPACK]106Legacy NDC20240420_defc625f-1efd-40de-87fa-fc6f5a872be2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1155-163629115501237 mL in 1 BOTTLE (63629-1155-1) 237 ml2020-10-060000-00-00NoNoCurrent