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.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 49483-280-06 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 49483-280-20 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 49483-280-00 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 49483-280-06 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 49483-280-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 49483-280-00 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 49483-280-06 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 49483-280-20 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 49483-280-00 | 0efc9e666f02… | f202fb6c5f17… |
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 |
|---|---|
| GUAIFENESIN | 400 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 495W7451VQ | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1147685 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 62c1f4aa-6571-414c-9a58-31e107b7db97 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| 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 Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 49483-280-06 | EA - Each | 49483-280 | b93edcce-7cd8-4ba1-886f-a2dfc6db3b3c | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ALKA SELTZER COLD Cold and Flu Severe Day Night Fast Dissolve | ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | 50762d7c-5efd-4f83-e063-6294a90abf7f | 2026-04-27 | Warnings | M012 |
| Cold and Flu Nighttime Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | L.N.K. International, Inc. | 6427b418-89d1-4eac-b25b-0adfefc204fc | 2026-04-27 | Warnings | M012 |
| Nighttime Sleep Aid | DIPHENHYDRAMINE HCL | Care One (American Sales Company) | bd5de3b3-7cb5-4403-b664-23ac70b9957f | 2026-04-27 | Warnings | M012 |
| Leader Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Cardinal Health 110, LLC. dba Leader | 333c7042-95b8-4d98-9df1-4287017afa36 | 2026-04-25 | Warnings | M012 |
| foster and thrive nasal | OXYMETAZOLINE HYDROCHLORIDE | Sportpharm LLC | f2d55d1b-c3d4-4c35-b761-681ed50273bd | 2026-04-24 | Warnings | M012 |
| Geri-Dryl allergy relief | DIPHENHYDRAMINE HCL | Sportpharm LLC | 2c4e0d5e-958d-4274-876a-52126c795c0f | 2026-04-24 | Warnings | M012 |
| ALKA SELTZER COLD Cold and Headache Maximum Strength Fast Dissolve | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | 50364a42-3333-51fe-e063-6394a90ab71e | 2026-04-24 | Warnings | M012 |
| ALKA SELTZER COLD Cold Flu Severe Fast Dissolve | CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Bayer HealthCare LLC. | 5036dc50-e95b-ea8d-e063-6394a90a6cfe | 2026-04-24 | Warnings | M012 |
| Cold and Flu Daytime Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | dcb33d5f-87fa-4043-9b6d-36adec96796c | 2026-04-24 | Warnings | M012 |
| Diphenhydramine HCl | DIPHENHYDRAMINE HCL | Cardinal Health 107, LLC | abc0e348-8532-4658-bd8c-d7dbe5a28c7d | 2026-04-23 | Warnings | M012 |
| nitetime severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Publix Super Markets Inc | c5535aaf-c029-48d8-97d1-105a49b5fd95 | 2026-04-23 | Warnings | M012 |
| ALKA SELTZER COLD Cold and Cough Maximum Strength Fast Dissolve | ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Bayer Healthcare LLC. | 50228b3c-d54a-485d-e063-6394a90a4403 | 2026-04-23 | Warnings | M012 |
| ALKA SELTZER COLD Cold and Flu Severe Fast Chewables | CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Bayer HealthCare LLC. | 5025a333-6378-bf59-e063-6394a90af4f0 | 2026-04-23 | Warnings | M012 |
| POLY-HIST DM | DEXCHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HBR | POLY PHARMACEUTICALS, INC. | 5025c99f-b946-e2e0-e063-6394a90a13fb | 2026-04-23 | Warnings | M012 |
| ALKA SELTZER COLD Cold and Allergy Maximum Strength Fast Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 5026611c-93e7-8f90-e063-6394a90a7baa | 2026-04-23 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | DOLGENCORP, LLC | c9c1db0f-6ba4-433c-b0ce-e99e9351c0b0 | 2026-04-23 | Warnings | M012 |
| Severe Cold and Flu Plus Congestion | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL | COSTCO WHOLESALE CORPORATION | 5180abbc-c6c4-4b82-b6e7-4504e3bcff0f | 2026-04-23 | Warnings | M012 |
| Severe Cold and Flu Night time | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | HyVee Inc | 4f963491-e1f0-494d-acb6-5f4d2b267d4a | 2026-04-22 | Warnings | M012 |
| Vicks Sinex SEVERE MOISTURIZING ULTRA FINE MIST | OXYMETAZOLINE HYDROCHLORIDE | Procter & Gamble Manufacturing GmbH | f4b01827-7444-3bfc-e053-2a95a90aebed | 2026-04-22 | Warnings | M012 |
| Vicks Sinex SEVERE ORIGINAL ULTRA FINE MIST | OXYMETAZOLINE HYDROCHLORIDE | Procter & Gamble Manufacturing GmbH, | cfd43b8f-8064-6b88-e053-2a95a90a329e | 2026-04-22 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1147685 | dextromethorphan HBr 20 MG / guaiFENesin 400 MG Oral Tablet | PSN | 62c1f4aa-6571-414c-9a58-31e107b7db97 | 4 |
| 1147685 | dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG Oral Tablet | SCD | 62c1f4aa-6571-414c-9a58-31e107b7db97 | 4 |
| 1147685 | guaifenesin 400 MG / dextromethorphan HBr 20 MG Oral Tablet | SY | 62c1f4aa-6571-414c-9a58-31e107b7db97 | 4 |
Packages#
| 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 |