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 |
|---|---|---|---|---|---|---|
| Allergy Relief Dye Free | DIPHENHYDRAMINE HYDROCHLORIDE 25MG | Walgreens | 36ba3ff2-1965-aa56-e063-6294a90afe17 | 2025-12-31 | Warnings | M012 |
| Sinus Congestion and Pain Severe | ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL | Wal-Mart Stores Inc | f51d1d52-39c2-4259-8b30-f9ac21edb265 | 2025-12-31 | Warnings | M012 |
| Durahist | DEXBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCL | Poly Pharmaceuticals, Inc. | 33d71863-5cac-669f-e063-6394a90a6f21 | 2025-12-30 | Warnings | M012 |
| Chest Congestion Relief | GUAIFENESIN | RUGBY LABORATORIES | 51b088bc-b44f-44b9-a08e-133509a35a2c | 2025-12-30 | Warnings | M012 |
| Chest Congestion Relief DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | RUGBY LABORATORIES | 60c9e493-f58c-45d6-bade-c95297512403 | 2025-12-30 | Warnings | M012 |
| BIO-RYTUSS | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Advanced Generic Corporation | e48e46e3-d3fa-4b25-8b07-bbecc4f0b64b | 2025-12-30 | Warnings | M012 |
| Altituss | DEXTROMETHORPHAN HBR, GUAIFENESIN | Alternative Pharmacal Corporation | e4ac96f5-2a3a-42a8-8db5-80de4dcdbd44 | 2025-12-30 | Warnings | M012 |
| Biocof | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HCL | Advanced Generic Corporation | 6ae6a0cb-b4fc-4e7d-aefc-6a52ca1ae3d6 | 2025-12-30 | Warnings | M012 |
| Altipres Pediatric | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Advanced Generic Corporation | 2a336896-a2f8-2a0c-e063-6294a90ae03a | 2025-12-30 | Warnings | M012 |
| Altipres | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Alternative Pharmacal Corporation | c5a43107-3eb8-46bb-87bd-20deafe28c3f | 2025-12-30 | Warnings | M012 |
| Mucus Relief DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Chain Drug Marketing Association, Inc. | d02f32c1-716e-4753-abba-ff97c4dc9e22 | 2025-12-30 | Warnings | M012 |
| NIGHTTIME SEVERE COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | KROGER | a690f5c5-ff41-4072-e053-2995a90a8e55 | 2025-12-29 | Warnings | M012 |
| Ninjacof | CHLOPHEDIANOL HCL AND PYRILAMINE MALEATE | Centurion Labs, LLC | e2bca40f-9c27-ec8b-2ff0-ef9847ba2037 | 2025-12-29 | Warnings | M012 |
| QUALITY CHOICE | COUGH DROPS CHERRY | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 23079194-b5e7-d5e6-e063-6394a90a4d8c | 2025-12-29 | Warnings | M012 |
| QUALITY CHOICE | COUGH DROPS HONEY LEMON | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 2307db15-592b-138a-e063-6394a90a23a5 | 2025-12-29 | Warnings | M012 |
| QUALITY CHOICE Cough Drops Vanilla Honey | COUGH DROPS VANILLA HONEY | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 23087ee3-26a0-e2b8-e063-6394a90abef4 | 2025-12-29 | Warnings | M012 |
| QUALITY CHOICE Cough Drops Black Cherry SUGAR FREE | COUGH DROPS BLACK CHERRY SUGAR FREE | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 230883da-de48-68e9-e063-6394a90a927c | 2025-12-29 | Warnings | M012 |
| QUALITY CHOICE | COUGH DROPS VITAMIN C | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 23086723-5718-6d02-e063-6394a90a03d2 | 2025-12-29 | Warnings | M012 |
| QUALITY CHOICE Cough Drops Creamy Strawberry | COUGH DROPS CREAMY STRAWBERRY | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 23085717-b2ee-175c-e063-6394a90a7f54 | 2025-12-29 | Warnings | M012 |
| QUALITY CHOICE | COUGH DROPS MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 2307bbe9-7c8f-4eff-e063-6394a90af4c3 | 2025-12-29 | 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 |