Guaifenesin

Product NDC
71335-9616
11-digit product format
713359616
Labeler code
71335
Product ID
71335-9616_97d545be-a78d-48b5-b774-ded0e82d742f
Type
HUMAN OTC DRUG
Nonproprietary name
Guaifenesin
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-08-01
Substance
GUAIFENESIN
Active strength
400 mg/1
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
495W7451VQGUAIFENESIN93-14-1GUAIFENESIN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-9616-17133596160130 TABLET in 1 BOTTLE, PLASTIC (71335-9616-1) 30 tablet2024-04-03NoNoHistorical
71335-9616-27133596160220 TABLET in 1 BOTTLE, PLASTIC (71335-9616-2) 20 tablet2022-12-28NoNoHistorical
71335-9616-37133596160350 TABLET in 1 BOTTLE, PLASTIC (71335-9616-3) 50 tablet2024-04-03NoNoHistorical
71335-9616-47133596160460 TABLET in 1 BOTTLE, PLASTIC (71335-9616-4) 60 tablet2024-04-03NoNoHistorical
71335-9616-57133596160540 TABLET in 1 BOTTLE, PLASTIC (71335-9616-5) 40 tablet2024-04-03NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Guifenisen 400 mgBryant Ranch Prepack2025-03-31HUMAN OTC DRUG LABEL102