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 79 of 178 · 3,551 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cherry Sore Throat Lozenge BENZOCAINE American Sales 49248a40-1ca3-6dd1-e054-00144ff88e88 2025-12-07 Warnings Exact identifier application number: M012 Sugar Free Honey Lemon Cough Drops MENTHOL American Sales 4896cbd1-57dd-1fc6-e054-00144ff8d46c 2025-12-07 Warnings Exact identifier application number: M012 cherry throat relief lozenges BENZOCAINE Cintas Corporation 49b25e9e-1d47-4a10-e054-00144ff8d46c 2025-12-07 Warnings Exact identifier application number: M012 cherry sore throat lozenge BENZOCAINE CVS Pharmacy 3c54974d-9d15-2fa1-e054-00144ff88e88 2025-12-07 Warnings Exact identifier application number: M012 honey lemon sore throat lozenges BENZOCAINE CVS Pharmacy 3c55009c-4b3e-135e-e054-00144ff8d46c 2025-12-07 Warnings Exact identifier application number: M012 sugar free menthol cough drops MENTHOL CVS Pharmacy 3bdd24a8-3b44-00cd-e054-00144ff8d46c 2025-12-07 Warnings Exact identifier application number: M012 sugar free honey lemon cough drops MENTHOL CVS Pharmacy 3c125b3a-e58f-5c06-e054-00144ff88e88 2025-12-07 Warnings Exact identifier application number: M012 CVS Menthol Cough Drops MENTHOL CVS Pharmacy de97d13b-bb67-d0e6-e053-2995a90aeb2c 2025-12-07 Warnings Exact identifier application number: M012 menthol cough drops MENTHOL American Sales 34dd34d1-1a08-3470-e054-00144ff8d46c 2025-12-06 Warnings Exact identifier application number: M012 DOLOGEN ACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATE Kramer Novis 656ea9ba-c9cf-44c6-af40-b8ba292ce38a 2025-12-05 Warnings Exact identifier application number: M012 Afrin No Drip Severe Congestion OXYMETAZOLINE HYDROCHLORIDE Bayer HealthCare LLC a79b5541-864b-412a-a085-96986ed6af59 2025-12-05 Warnings Exact identifier application number: M012 Afrin No Drip Extra Moisturizing OXYMETAZOLINE HYDROCHLORIDE Bayer HealthCare LLC. 346f32cb-74cb-4896-b770-76d5f829a17d 2025-12-05 Warnings Exact identifier application number: M012 Afrin No Drip Original Pump Mist OXYMETAZOLINE HYDROCHLORIDE Bayer HealthCare LLC. 530b2d27-5883-489e-87fa-90b45eb93b3c 2025-12-05 Warnings Exact identifier application number: M012 Coricidin HBP Cough and Cold Cough Suppressant, Antihistamine CHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE Bayer HealthCare LLC. ee666963-e686-4374-b52b-a677f1cd4114 2025-12-05 Warnings Exact identifier application number: M012 Afrin No-Drip Allergy Sinus OXYMETAZOLINE HYDROCHLORIDE Bayer HealthCare LLC 3beb5839-7422-449d-e054-00144ff88e88 2025-12-05 Warnings Exact identifier application number: M012 Coricidin HBP Nighttime Multi-Symptom Cold ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE Bayer HealthCare LLC. 513ca24f-1262-4a2d-e054-00144ff8d46c 2025-12-05 Warnings Exact identifier application number: M012 Afrin Severe Congestion OXYMETAZOLINE HYDROCHLORIDE Bayer HealthCare LLC. a49a506e-aca2-4af0-a50b-dca2c031e61d 2025-12-05 Warnings Exact identifier application number: M012 Throat Coat Sweet Orange Fennel MENTHOL Traditional Medicinals, Inc. a746cef4-1fb4-45cf-e053-2995a90a02c8 2025-12-05 Warnings Exact identifier application number: M012 Guaifenesin GUAIFENESIN Health Pharma USA LLC 31755594-3e1c-b290-e063-6394a90aba61 2025-12-05 Warnings Exact identifier application number: M012 Tabcin Extra Strength ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, Pharmadel LLC 0670c33e-8a3c-ae00-e063-6294a90a165b 2025-12-05 Warnings Exact identifier application number: M012
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