Home NDC 81033-102 Guaifenesin
Product NDC 81033-102
11-digit product format 810330102
Labeler code 81033
Product ID 81033-102_316ac9e6-8d03-f55a-e063-6294a90a8540
Type HUMAN OTC DRUG
Nonproprietary name Guaifenesin
Dosage form LIQUID
Route ORAL
Labeler KESIN PHARMA CORPORATION
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-11-20
Substance GUAIFENESIN
Active strength 100 mg/5mL
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 Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Guaifenesin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 100 mg/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 495W7451VQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310604 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 81033-102-05 Guaifenesin 5 mL in 1 CUP, UNIT-DOSE LIQUID 5 7 81033-102-10 Guaifenesin 10 mL in 1 CUP, UNIT-DOSE LIQUID 10 7 81033-102-51 Guaifenesin 50 in 1 CARTON LIQUID 50 7 81033-102-52 Guaifenesin 50 in 1 CARTON LIQUID 50 7 81033-102-16 Guaifenesin 473 mL in 1 BOTTLE LIQUID 473 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81033-102 GUAIFENESIN LIQUID [KESIN PHARMA CORPORATION] 7 Current NDC, 4 package rows 20250331_365c01b7-a197-4876-85fc-42204f787e3a.zip 81033-102 GUAIFENESIN LIQUID [KESIN PHARMA CORPORATION] 1 Current NDC, 1 package rows 20250406_31b8ad0a-3637-03db-e063-6394a90acdc3.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 81033-102-05 81033010205 5 mL in 1 CUP, UNIT-DOSE 5 ml Historical 81033-102-10 81033010210 10 mL in 1 CUP, UNIT-DOSE 10 ml Historical 81033-102-16 81033010216 473 mL in 1 BOTTLE (81033-102-16) 473 ml 2025-04-01 No No Current 81033-102-51 81033010251 50 CUP, UNIT-DOSE in 1 CARTON (81033-102-51) / 5 mL in 1 CUP, UNIT-DOSE (81033-102-05) 2023-11-20 No No Current 81033-102-52 81033010252 50 CUP, UNIT-DOSE in 1 CARTON (81033-102-52) / 10 mL in 1 CUP, UNIT-DOSE (81033-102-10) 2023-11-20 No No Current