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 |
|---|---|---|---|---|---|---|
| Walgreen NightTime Cold and Flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE | WALGREENS CO. | 6b3766e6-d0d4-49e0-90da-fc893aef3329 | 2025-11-25 | Warnings | M012 |
| Adult Allergy Relief Dye Free | DIPHENHYDRAMINE HYDROCHLORIDE | WALGREEN COMPANY | 586310f3-0014-4cfc-9d86-961b3fb7aa8c | 2025-11-25 | Warnings | M012 |
| childrens Allergy Dye Free Wal Dryl | DIPHENHYDRAMINE HYDROCHLORIDE | WALGREEN CO. | 4e64e040-1662-4dc9-b33f-3e119e0b3f7b | 2025-11-25 | Warnings | M012 |
| Walgreen | NASAL | WALGREENS CO | d38f8406-d7b9-472c-a472-58968bbdb993 | 2025-11-25 | Warnings | M012 |
| Theraflu Flu Relief Max Strength Nighttime | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | 780907b8-34ba-4ec8-bcdf-b2a31bd111df | 2025-11-25 | Warnings | M012 |
| Robitussin Elderberry Maximum Strength Cough plus Chest Congestion DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Haleon US Holdings LLC | d13efbcd-1277-45d0-8389-1ba0337f7a24 | 2025-11-25 | Warnings | M012 |
| Childrens Robitussin Elderberry Cough and Chest Congestion DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Haleon US Holdings LLC | fe903448-b422-42e0-b05b-aeb3e5481e3c | 2025-11-25 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | DOLGENCORP INC | 1d4fcb76-22d1-7292-e063-6394a90af920 | 2025-11-25 | Warnings | M012 |
| ROBITUSSIN LONG-ACTING COUGH Soft CHEWS | DEXTROMETHORPHAN HYDROBROMIDE | Haleon US Holdings LLC | f22248b7-7abd-4df7-a986-dae357ebe8f1 | 2025-11-25 | Warnings | M012 |
| ROBITUSSIN Nighttime Cough DM Soft CHEWS | DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Haleon US Holdings LLC | 39468746-e06d-4849-9d06-9af4d14351b0 | 2025-11-25 | Warnings | M012 |
| Daytime and Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Grocery Outlet, Inc. | 4478fd51-bae3-6108-e063-6394a90a07ca | 2025-11-25 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | CHAIN DRUG MARKETING ASSOCIATION INC. | 395bb39a-e26f-f4f2-e063-6394a90ae721 | 2025-11-25 | Warnings | M012 |
| day time | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | H E B | eaf3af6a-de5b-43fe-83ff-9641646e0f6b | 2025-11-25 | Warnings | M012 |
| MUCINEX Rapid Clear Pain, Headache and Mucus Congestion and Nighttime Liquid Gels | ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | RB Health (US) LLC | 38571853-992f-9998-e063-6394a90a8581 | 2025-11-24 | Warnings | M012 |
| Basic Care Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Amazon.com Services LLC | e19b561c-fb76-4355-a306-d3dc46930bf2 | 2025-11-24 | Warnings | M012 |
| Sinus Decongestion | PSEUDOEPHEDRINE HCL | Kroger Company | 73c3a9ac-43d6-4ecd-9add-36ca1c40ba9c | 2025-11-24 | Warnings | M012 |
| Tussin Multi Symptom Cold CF | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI | Cardinal Health (Leader) 70000 | 14c507df-fbac-4a09-a66c-b91c2abbf550 | 2025-11-24 | Warnings | M012 |
| Severe Nighttime Cold and Flu Relief | ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE PHENYLEPHRINE HCI | Family Dollar (FAMILY WELLNESS) | e5c90d6e-70aa-4886-bc81-293e0dcf5638 | 2025-11-24 | Warnings | M012 |
| Throat Coat Eucalyptus Mint | MENTHOL | Traditional Medicinals, Inc. | a7a86f1b-30e8-6f5d-e053-2a95a90a2a82 | 2025-11-21 | Warnings | M012 |
| Throat Coat Sweet Orange Fennel | MENTHOL | Traditional Medicinals, Inc. | 4538248f-11cc-d6b2-e063-6294a90a652c | 2025-11-21 | 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 |