Home NDC 0121-1276 GUAIFENESIN DM
Product NDC 0121-1276
11-digit product format 001211276
Labeler code 0121
Product ID 0121-1276_c50b4c5c-6f55-4118-a282-e0b490704e49
Type HUMAN OTC DRUG
Nonproprietary name GUAIFENESIN and DEXTROMETHORPHAN
Dosage form SYRUP
Route ORAL
Labeler PAI Holdings, LLC dba PAI Pharma
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 1992-07-01
Substance GUAIFENESIN; DEXTROMETHORPHAN
Active strength 200; 20 mg/10mL; mg/10mL
Pharmacologic classes Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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 DM
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 200 mg/10mL DEXTROMETHORPHAN 20 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 495W7451VQ Internal UNII lookup 7355X3ROTS Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 996520 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 0121-1276-00 GUAIFENESIN DM 10 in 1 TRAY SYRUP 10 8 0121-1276-00 GUAIFENESIN DM 10 in 1 CASE SYRUP 10 8 0121-1276-10 GUAIFENESIN DM 10 mL in 1 CUP, UNIT-DOSE SYRUP 10 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTROMETHORPHAN ACTIVE INGREDIENT 7355X3ROTS GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [PHARMACEUTICAL ASSOCIATES, INC.] 1 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [PHARMACEUTICAL ASSOCIATES, INC.] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [PHARMACEUTICAL ASSOCIATES, INC.] 1 GUAIFENESIN ACTIVE MOIETY 495W7451VQ GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [PHARMACEUTICAL ASSOCIATES, INC.] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [PHARMACEUTICAL ASSOCIATES, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [PHARMACEUTICAL ASSOCIATES, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [PHARMACEUTICAL ASSOCIATES, INC.] 1 MENTHOL INACTIVE INGREDIENT L7T10EIP3A GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [PHARMACEUTICAL ASSOCIATES, INC.] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [PHARMACEUTICAL ASSOCIATES, INC.] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [PHARMACEUTICAL ASSOCIATES, INC.] 1 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [PHARMACEUTICAL ASSOCIATES, INC.] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [PHARMACEUTICAL ASSOCIATES, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [PHARMACEUTICAL ASSOCIATES, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0121-1276 GUAIFENESIN DM (GUAIFENESIN AND DEXTROMETHORPHAN) SYRUP [PAI HOLDINGS, LLC DBA PAI PHARMA] 8 Current NDC, Legacy NDC, 3 package rows 20241113_ff970fff-d1a3-4322-83b4-34e361431a1c.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 70 of 178 · 3,551 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Quality Choice Honey Lemon Cough Drops HONEY LEMON COUGH DROPS Chain Drug Marketing Association, Inc. 1fd09b04-9c79-da20-e063-6394a90ae263 2025-12-22 Warnings Exact identifier application number: M012 Quality Choice Menthol Cough Drops MENTHOL COUGH DROPS Chain Drug Marketing Association, Inc. 3364470e-d9bb-42a6-9bd5-80c0bed8bc9e 2025-12-22 Warnings Exact identifier application number: M012 Quality Choice Honey Lemon Sugar Free Cough Drops HONEY LEMON SUGAR FREE COUGH DROPS Chain Drug Marketing Association, Inc. 1fd0a790-c67c-216f-e063-6294a90ae971 2025-12-22 Warnings Exact identifier application number: M012 CAREALL Diphenhydramine DIPHENHYDRAMINE HYDROCHLORIDE New World Imports, Inc f3b177ef-55d5-4525-bf33-99205c414a5b 2025-12-22 Warnings Exact identifier application number: M012 CAREALL Allergy Relief DIPHENHYDRAMINE HYDROCHLORIDE New World Imports, Inc af2f8389-d696-4060-8abd-6eda04e73009 2025-12-22 Warnings Exact identifier application number: M012 BASIC CARE DAYTIME NIGHTTIME SEVERE COLD AND FLU ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE Amazon.com Services LLC 82e68c65-9898-4106-a2f8-e39d124c703e 2025-12-22 Warnings Exact identifier application number: M012 Nighttime Cold and Flu Relief ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE Harris Teeter, LLC 89fd57d2-fe49-41cb-b02e-9643e526cf47 2025-12-22 Warnings Exact identifier application number: M012 Menthol Cough Drop MENTHOL Walgreens 464f6645-ca33-1722-e054-00144ff8d46c 2025-12-21 Warnings Exact identifier application number: M012 Cherry Cough Drops MENTHOL Walgreen Co. 47f38e79-c730-21b9-e054-00144ff88e88 2025-12-21 Warnings Exact identifier application number: M012 Cherry Cough Drop MENTHOL Walgreen Co. 47522852-005a-2a66-e054-00144ff8d46c 2025-12-21 Warnings Exact identifier application number: M012 Honey Lemon Cough Drop MENTHOL Walgreens Co, 47653657-80b5-482f-e054-00144ff88e88 2025-12-21 Warnings Exact identifier application number: M012 Honey Lemon Cough Drop MENTHOL Walgreen Co. 47f89d33-6e0a-4bb4-e054-00144ff88e88 2025-12-21 Warnings Exact identifier application number: M012 Strawberry Cough Drop MENTHOL 2.7 MG Walgreen Co. 4766afa8-fdaf-05e5-e054-00144ff8d46c 2025-12-21 Warnings Exact identifier application number: M012 SF Menthol Cough Drop MENTHOL Walgreen Co. 477b9fc3-c3c5-647e-e054-00144ff8d46c 2025-12-21 Warnings Exact identifier application number: M012 SF Honey Lemon Cough Drop MENTHOL Walgreen Co. 477cedee-6bd3-2a34-e054-00144ff8d46c 2025-12-21 Warnings Exact identifier application number: M012 Cherry Sore Throat Lozenge BENZOCAINE Walgreens Co. 47e0f809-0b30-2b23-e054-00144ff8d46c 2025-12-21 Warnings Exact identifier application number: M012 Sugar Free Honey Lemon Cough Drops MENTHOL Walgreen 835e276a-493e-1038-e053-2a91aa0a7ea2 2025-12-21 Warnings Exact identifier application number: M012 Walgreens Mixed Berry Benz-Dex Lozenges BENZOCAINE Walgreen e108731f-6b77-225a-e053-2a95a90ac25c 2025-12-21 Warnings Exact identifier application number: M012 Cherry Cough Drops MENTHOL Walmart Stores Inc. 318e7acb-0ebb-4518-e054-00144ff88e88 2025-12-21 Warnings Exact identifier application number: M012 cherry cough drops MENTHOL Walmart Stores Inc. 316968e1-7715-4caa-e054-00144ff8d46c 2025-12-21 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 0121-1276-00 00121127600 10 TRAY in 1 CASE (0121-1276-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0121-1276-10) 10 tray 1992-07-01 0000-00-00 No No Current 0121-1276-10 00121127610 10 mL in 1 CUP, UNIT-DOSE 10 ml Historical