Home NDC 0121-0744 GUAIFENESIN
Product NDC 0121-0744
11-digit product format 001210744
Labeler code 0121
Product ID 0121-0744_25a970c7-0016-4f22-9e94-1e20e1319e3e
Type HUMAN OTC DRUG
Nonproprietary name GUAIFENESIN
Dosage form SOLUTION
Route ORAL
Labeler PAI Holdings, LLC dba PAI Pharma
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2002-09-01
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 0121-0744-04 GUAIFENESIN 118 mL in 1 BOTTLE SOLUTION 118 9 0121-0744-08 GUAIFENESIN 237 mL in 1 BOTTLE SOLUTION 237 9 0121-0744-16 GUAIFENESIN 473 mL in 1 BOTTLE SOLUTION 473 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ GUAIFENESIN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 2 GUAIFENESIN ACTIVE MOIETY 495W7451VQ GUAIFENESIN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 2 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 GUAIFENESIN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 2 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP GUAIFENESIN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 2 FD&C GREEN NO. 3 INACTIVE INGREDIENT 3P3ONR6O1S GUAIFENESIN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA GUAIFENESIN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 2 HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) INACTIVE INGREDIENT 8136Y38GY5 GUAIFENESIN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 2 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU GUAIFENESIN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 2 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR GUAIFENESIN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R GUAIFENESIN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0121-0744 GUAIFENESIN SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA] 9 Current NDC, Legacy NDC, 3 package rows 20241113_c2e53fb5-2798-47c8-9285-d1077d46e629.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 Marketing end Sample Exclude flag Status 0121-0744-04 00121074404 118 mL in 1 BOTTLE (0121-0744-04) 118 ml 2002-09-01 0000-00-00 No No Current 0121-0744-08 00121074408 237 mL in 1 BOTTLE (0121-0744-08) 237 ml 2002-09-01 0000-00-00 No No Current 0121-0744-16 00121074416 473 mL in 1 BOTTLE (0121-0744-16) 473 ml 2002-09-01 0000-00-00 No No Current