Home NDC 0121-1744 GUAIFENESIN
Product NDC 0121-1744
11-digit product format 001211744
Labeler code 0121
Product ID 0121-1744_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 0121-1744-00 GUAIFENESIN 10 in 1 CASE SOLUTION 10 9 0121-1744-00 GUAIFENESIN 10 in 1 TRAY SOLUTION 10 9 0121-1744-05 GUAIFENESIN 5 mL in 1 CUP, UNIT-DOSE SOLUTION 5 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ GUAIFENESIN LIQUID [CARDINAL HEALTH] 3 GUAIFENESIN ACTIVE MOIETY 495W7451VQ GUAIFENESIN LIQUID [CARDINAL HEALTH] 3 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 GUAIFENESIN LIQUID [CARDINAL HEALTH] 3 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP GUAIFENESIN LIQUID [CARDINAL HEALTH] 3 FD&C GREEN NO. 3 INACTIVE INGREDIENT 3P3ONR6O1S GUAIFENESIN LIQUID [CARDINAL HEALTH] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA GUAIFENESIN LIQUID [CARDINAL HEALTH] 3 HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) INACTIVE INGREDIENT S38J6RZN16 GUAIFENESIN LIQUID [CARDINAL HEALTH] 3 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU GUAIFENESIN LIQUID [CARDINAL HEALTH] 3 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR GUAIFENESIN LIQUID [CARDINAL HEALTH] 3 WATER INACTIVE INGREDIENT 059QF0KO0R GUAIFENESIN LIQUID [CARDINAL HEALTH] 3 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 0121-1744 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 75 of 177 · 3,534 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join HEB Honey Lemon Cough Drops MENTHOL HEB c19a79bc-9872-2e87-e053-2a95a90a9427 2025-12-13 Warnings Exact identifier application number: M012 Cold and Flu Daytime Nighttime ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL WALMART INC. 26f55169-4b37-4a36-88ee-064d6e962065 2025-12-12 Warnings Exact identifier application number: M012 Allergy Relief DIPHENHYDRAMINE HCL Walgreen Company 39ce76a3-b7a8-43be-9b61-5c1446cd9e90 2025-12-12 Warnings Exact identifier application number: M012 Cold and Flu maximum strength ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL Rite Aid Corporation ac01206f-a717-4c0b-8a03-fab0a4fd154b 2025-12-12 Warnings Exact identifier application number: M012 Sinus Severe ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL Strategic Sourcing Services LLC dcb80dd5-465d-4792-947a-3044e25a5284 2025-12-12 Warnings Exact identifier application number: M012 Vapor Rub COUGH SUPPRESSANT Neilmed Pharmaceuticals Inc. 39190f9f-8a5a-e4d8-e063-6294a90a57dd 2025-12-12 Warnings Exact identifier application number: M012 Allergy Relief, 24-7 Life by 7-Eleven DIPHENHYDRAMINE HCL TABLET, FILM COATED Lil' Drug Store Products, Inc. 45c4cd6c-327d-5950-e063-6394a90a3a21 2025-12-12 Warnings Exact identifier application number: M012 Menthol cough drops MENTHOL Family Dollar 44bb3b95-b2ba-470e-e054-00144ff88e88 2025-12-12 Warnings Exact identifier application number: M012 menthol cough drops MENTHOL Family Dollar 44bb9c7b-994b-4ab8-e054-00144ff8d46c 2025-12-12 Warnings Exact identifier application number: M012 cherry cough drops MENTHOL Family Dollar 44be9837-f15a-09f2-e054-00144ff8d46c 2025-12-12 Warnings Exact identifier application number: M012 cherry cough drops MENTHOL Family Dollar 44bcae39-2389-09ee-e054-00144ff8d46c 2025-12-12 Warnings Exact identifier application number: M012 honey lemon cough drops MENTHOL Family Dollar 46635813-66c4-504c-e054-00144ff8d46c 2025-12-12 Warnings Exact identifier application number: M012 honey lemon cough drops MENTHOL Family Dollar 455b0f4b-0526-2361-e054-00144ff8d46c 2025-12-12 Warnings Exact identifier application number: M012 Family Wellness Strawberry Cough Drops MENTHOL Family Dollar f92466ac-dd93-9ac5-e053-6294a90a9291 2025-12-12 Warnings Exact identifier application number: M012 GoodSense Menthol Cough Drops MENTHOL Geiss, Destin, Dunn c6b25d69-8930-6867-e053-2a95a90ad208 2025-12-12 Warnings Exact identifier application number: M012 Good Sense Cherry Cough Drops MENTHOL Geiss, Destin, Dunn c72db7f0-9324-8ed2-e053-2995a90a9868 2025-12-12 Warnings Exact identifier application number: M012 Good Sense Honey Lemon Cough Drops MENTHOL Geiss, Destin, Dunn c72e557f-0211-81b9-e053-2995a90a1437 2025-12-12 Warnings Exact identifier application number: M012 Good Sense Cherry Benzocaine Lozenges BENZOCAINE Geiss, Destin, Dunn c7404c94-09eb-5cc5-e053-2995a90af021 2025-12-12 Warnings Exact identifier application number: M012 Good Sense SF Honey Lemon Cough Drops MENTHOL Geiss, Destin, Dunn e11ed21f-6ceb-5908-e053-2995a90aea46 2025-12-12 Warnings Exact identifier application number: M012 Severe Congestion Relief Maximum Strength Sinus ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL Wal-Mart Stores Inc 59918b8b-5c91-468f-834e-66020dc1ae12 2025-12-12 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 0121-1744-00 00121174400 10 TRAY in 1 CASE (0121-1744-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-1744-05) 10 tray 2002-09-01 0000-00-00 No No Current 0121-1744-05 00121174405 5 mL in 1 CUP, UNIT-DOSE 5 ml Historical 0121-1744-10 00121174410 10 TRAY in 1 CASE (0121-1744-10) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE 10 tray 2002-09-01 0000-00-00 No No Current 0121-1744-15 00121174415 10 TRAY in 1 CASE (0121-1744-15) > 10 CUP, UNIT-DOSE in 1 TRAY > 15 mL in 1 CUP, UNIT-DOSE 10 tray 2002-09-01 0000-00-00 No No Current