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 |
|---|---|---|---|---|---|---|
| ORIGINAL Nasal PUMP MIST No Drip | OXYMETAZOLINE HYDROCHLORIDE | WinCo FOODS, LLC | ac27fd75-4fe4-433c-a434-2dac16c895c7 | 2026-08-07 | Warnings | M012 |
| Winco Foods Childrens Allergy Relief Dye Free | DIPHENHYDRAMINE HYDROCHLORIDE | WINCO FOODS, LLC | a1367804-37c9-4906-858f-8feeb748d8d3 | 2026-08-07 | Warnings | M012 |
| Severe Congestion Nasal Anti-Drip Nasal Decongestant | OXYMETAZOLINE HYDROCHLORIDE | WinCo FOODS, LLC | a09c2d02-334a-4840-b2d0-327121cec994 | 2026-08-07 | Warnings | M012 |
| Daytime Nighttime Intense Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Walgreen Company | 03aa43fd-4962-4c2c-9edd-e422a629a0e3 | 2026-08-06 | Warnings | M012 |
| Allergy Multi-Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL | ARMY AND AIR FORCE EXCHANGE SERVICE | f311b56f-b959-4070-9b23-82c642dd98b8 | 2026-08-06 | Warnings | M012 |
| Cold Relief Multi-Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | L.N.K. International, Inc. | 2ed25f69-89ef-4c50-946a-7e7b9df1ca8a | 2026-08-06 | Warnings | M012 |
| Eucamint | MENTHOL, CAMPHOR | Indiana Botanic Gardens | d79bc8de-9efb-4996-a55c-accda0f8edb2 | 2026-08-06 | Warnings | M012 |
| NICOTINE GUM | NICOTINE POLACRILEX | Guangzhou Shuimu Jiahe Trading Co., Ltd. | 4e88dab4-8e13-f074-e063-6394a90a3908 | 2026-08-06 | Warnings | M012 |
| Oneoo Nicotine Gum (Mint) | NICOTINE POLACRILEX | Guangzhou Shuimu Jiahe Trading Co., Ltd. | 54b1329b-b422-29a5-e063-6294a90a8780 | 2026-08-06 | Warnings | M012 |
| Sine Aid PEAK MISERY | OXYMETAZOLINE HYDROCHLORIDE | Infirst Healthcare Inc. | 586a2a14-7048-0c8b-e063-6394a90a65b7 | 2026-08-06 | Warnings | M012 |
| DRX CHOICE Daytime and Nighttime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Raritan Pharmaceuticals Inc | b745f45d-2042-4daa-9932-241836d7734b | 2026-08-06 | Warnings | M012 |
| Acetaminophen, Dextromethorphan HBr | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | NUVICARE LLC | 6713fdff-0e4e-4a9d-b218-34f786339c57 | 2026-08-06 | Warnings | M012 |
| Daytime Cold, Nighttime Cold multi-symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | 3b462a5d-d48b-4b73-b5d4-d7944730bbdd | 2026-08-06 | Warnings | M012 |
| TOPCARE DAY TIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Topco Associates LLC | d1b89d17-b3b9-4133-88a3-8cd7c4efafa9 | 2026-08-05 | Warnings | M012 |
| Sinufrin Quick Relief Decongestant | SINUFRIN | Neilmed pharmaceuticals Inc. | 0c36a34e-462d-713c-e063-6294a90a1776 | 2026-08-05 | Warnings | M012 |
| No Drip | OXYMETAZOLINE HYDROCHLORIDE | NeilMed Pharmaceuticals Inc | e9b799ad-9164-7f30-e053-2a95a90a00c5 | 2026-08-05 | Warnings | M012 |
| ALKA SELTZER COLD Cold Flu and Congestion Fast Dissolve | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 507284c3-cad9-d65c-e063-6394a90a58a8 | 2026-08-05 | Warnings | M012 |
| cough and cold relief HBP | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | United Natural Foods, Inc. dba UNFI | 90482e7a-d7c7-4127-972d-5ee55e55ed1c | 2026-08-04 | Warnings | M012 |
| DM Max | DEXTROMETHORPHAN HBR, GUAIFENESIN | Walgreen Company | 78edeb7a-4712-4f04-9d76-d5b2d20ce76d | 2026-08-04 | Warnings | M012 |
| Cough and Cold HBP | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Better Living Brands, LLC | 33f34aa2-3b37-4e51-8428-4a12708aa064 | 2026-08-04 | 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 |