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 |
|---|---|---|---|---|---|---|
| equaline nasal | OXYMETAZOLINE HCL | United Natural Foods, Inc. dba UNFI | 69308693-a094-42a9-a041-e73647a25cc1 | 2024-08-27 | Warnings | M012 |
| signature care nasal decongestant | OXYMETAZOLINE HYDROCHLORIDE | Safeway | f9ac80d1-3753-412b-a407-18a6b50e5d1c | 2024-08-27 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Day and Night Cold and Flu PowerMax Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | 20ac6010-84f4-eeff-e063-6294a90a50a7 | 2024-08-27 | Warnings | M012 |
| Exchange Select Nasal | OXYMETAZOLINE HCL | Army & Air Force Exchange Service | 40d2090d-c332-4dcb-9f43-5ee467e7b3d1 | 2024-08-27 | Warnings | M012 |
| DG Health Nasal | OXYMETAZOLINE HYDROCHLORIDE | Dolgencorp, LLC | debcda99-c605-4941-b873-9e4dbae27483 | 2024-08-27 | Warnings | M012 |
| Good Neighbor Pharmacy Nasal | OXYMETAZOLINE HCL | Amerisource Bergen | d374d697-2b57-4558-a20b-d3d89aea82d7 | 2024-08-27 | Warnings | M012 |
| nasal | OXYMETAZOLINE HCL | Meijer Distribution Inc | 3984cbc3-b60c-40a7-bc3a-7d1f600503ac | 2024-08-27 | Warnings | M012 |
| foster and thrive nasal | OXYMETAZOLINE HYDROCHLORIDE | Strategic Sourcing Services LLC | e6e51821-03ae-4ec3-82a9-b4a8feacd996 | 2024-08-27 | Warnings | M012 |
| Pyrilamine Maleate and Dextromethorphan Hydrobromide | PYRILAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE | Westminster Pharmaceuticals, LLC | dd068449-9d24-41e6-8a6e-f69c9fe263f2 | 2024-08-26 | Warnings | M012 |
| basic care nasal | OXYMETAZOLINE HYDROCHLORIDE | Amazon.com Services LLC | a154e500-2b45-4242-a26c-9530849f99df | 2024-08-23 | Warnings | M012 |
| Daytime Nighttime Ultra Concentrated Cold and Flu | DAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, PHENYLEPHRINE HCL AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE | TARGET CORPORATION | 0c0cf76f-2dd3-45ef-e063-6394a90a9fef | 2024-08-22 | Warnings | M012 |
| Day Cold and Flu and Night Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, TRIPROLIDINE HCL | TARGET CORPORATION | 08ee56d1-b11d-3e36-e063-6294a90acd5f | 2024-08-22 | Warnings | M012 |
| Maximum Strength Daytime Cold and Flu and Nighttime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE,TRIPROLIDINE HYDROCHLORIDE | TARGET CORPORATION | 0fc523ce-55a7-6384-e063-6394a90aad3f | 2024-08-22 | Warnings | M012 |
| Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Walgreens | 8045aef9-22bc-4146-b494-dbb1ffef06df | 2024-08-19 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION, INC. | 5a2053d4-9c0d-4613-9cf5-0067173f3730 | 2024-08-16 | Warnings | M012 |
| QUALITY CHOICE Long Acting Cough Softgel | DEXTROMETHORPHAN HYDROBROMIDE | Chain Drug Marketing Association, Inc. | f1ea7dfc-c605-45a1-ad1d-6e636a8a7b1c | 2024-08-16 | Warnings | M012 |
| pseudoephedrine hydrochloride | PSEUDOEPHEDRINE HCL | Padagis Israel Pharmaceuticals Ltd | 458594e1-8d99-4de3-8923-2fd8ce2fc406 | 2024-08-16 | Warnings | M012 |
| Halls Sugar Free Mountain Menthol | MENTHOL | Mondelez Global LLC | 54e0d57e-1f48-45e2-86b3-0e50775996f4 | 2024-08-15 | Warnings | M012 |
| SanaTos X Children | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI | Pharmadel LLC | 1fc1408c-c540-39ab-e063-6394a90aa477 | 2024-08-15 | Warnings | M012 |
| Diphenhydramine HCL | DIPHENHYDRAMINE HCL | NuCare Pharmaceuticals, Inc. | 489645ad-d7da-5f52-e054-00144ff8d46c | 2024-08-14 | 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 |