Home NDC 49483-280 MUCOSA DM
Product NDC 49483-280
11-digit product format 494830280
Labeler code 49483
Product ID 49483-280_2d9cef2f-22cd-ed8e-e063-6394a90ad8a8
Type HUMAN OTC DRUG
Nonproprietary name GUAIFENESIN DEXTROMETHORPHAN
Dosage form TABLET
Route ORAL
Labeler TIME CAP LABORATORIES, INC.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-04-17
Substance GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 400; 20 mg/1; mg/1
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 MUCOSA DM
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 400 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 20 mg/1
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 9D2RTI9KYH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1147685 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49483-280-00 MUCOSA DM 100000 in 1 CARTON TABLET 100000 4 49483-280-06 MUCOSA DM 60 in 1 BOTTLE, PLASTIC TABLET 60 4 49483-280-20 MUCOSA DM 200 in 1 BOTTLE TABLET 200 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [BRYANT RANCH PREPACK] 1000 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [BRYANT RANCH PREPACK] 1000 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [BRYANT RANCH PREPACK] 1000 GUAIFENESIN ACTIVE MOIETY 495W7451VQ MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [BRYANT RANCH PREPACK] 1000 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [BRYANT RANCH PREPACK] 1000 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [BRYANT RANCH PREPACK] 1000 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [BRYANT RANCH PREPACK] 1000 POVIDONES INACTIVE INGREDIENT FZ989GH94E MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [BRYANT RANCH PREPACK] 1000 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [BRYANT RANCH PREPACK] 1000 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [BRYANT RANCH PREPACK] 1000 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [BRYANT RANCH PREPACK] 1000 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [TIME CAP LABORATORIES, INC.] 1 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH MUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [MAJOR PHARMACEUTICALS INC] 1 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [TIME CAP LABORATORIES, INC.] 1 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ MUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [MAJOR PHARMACEUTICALS INC] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [TIME CAP LABORATORIES, INC.] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS MUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [MAJOR PHARMACEUTICALS INC] 1 GUAIFENESIN ACTIVE MOIETY 495W7451VQ MUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [MAJOR PHARMACEUTICALS INC] 1 GUAIFENESIN ACTIVE MOIETY 495W7451VQ MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [TIME CAP LABORATORIES, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [MAJOR PHARMACEUTICALS INC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [TIME CAP LABORATORIES, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [TIME CAP LABORATORIES, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [MAJOR PHARMACEUTICALS INC] 1 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [TIME CAP LABORATORIES, INC.] 1 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D MUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [MAJOR PHARMACEUTICALS INC] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [TIME CAP LABORATORIES, INC.] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E MUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [MAJOR PHARMACEUTICALS INC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [TIME CAP LABORATORIES, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [MAJOR PHARMACEUTICALS INC] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 MUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [MAJOR PHARMACEUTICALS INC] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [TIME CAP LABORATORIES, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN ) TABLET [TIME CAP LABORATORIES, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP MUCUS RELIEF DM (GUAIFENESIN, DEXTROMETHORPHAN HBR) TABLET [MAJOR PHARMACEUTICALS INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49483-280 MUCOSA DM (GUAIFENESIN DEXTROMETHORPHAN) TABLET [TIME CAP LABORATORIES, INC.] 4 Current NDC, Legacy NDC, 3 package rows 20250212_62c1f4aa-6571-414c-9a58-31e107b7db97.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 76 of 180 · 3,583 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join HEB SF Honey Lemon Cough Drops MENTHOL HEB d09ed4bb-7595-5e54-e053-2a95a90aa109 2025-12-13 Warnings Exact identifier application number: M012 HEB Cherry Cough Drops MENTHOL HEB c198e3c7-5ba7-ece6-e053-2995a90adb38 2025-12-13 Warnings Exact identifier application number: M012 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 Medicated Chest Rub CAMPHOR, EUCALYPTUS OIL, MENTHOL Cardinal Health, 110 dba LEADER b7393668-1450-4e85-9793-d400daf39b43 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
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 49483-280-00 49483028000 100000 TABLET in 1 CARTON (49483-280-00) 100000 tablet 2018-12-17 0000-00-00 No No Current 49483-280-06 49483028006 60 TABLET in 1 BOTTLE, PLASTIC (49483-280-06) 60 tablet 2018-12-17 0000-00-00 No No Current 49483-280-20 49483028020 200 TABLET in 1 BOTTLE (49483-280-20) 200 tablet 2023-09-15 No No Current