Dextromethorphan HBr. and Guaifenesin
- Product NDC
- 84415-014
- 11-digit product format
- 844150014
- Labeler code
- 84415
- Product ID
- 84415-014_5cca83db-66f8-4029-e063-6394a90aa7a0
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorphan HBr. and Guaifenesin
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Everpharm LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-01-16
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
- Active strength
- 10; 100 mg/5mL; mg/5mL
- 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
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
- Dextromethorphan HBr. and Guaifenesin
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/5mL |
| GUAIFENESIN | 100 mg/5mL |
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 |
| e2db08c6-133f-4f4f-afb4-e90a2418d6f6 | Product name | 1 | 20230320 |
| ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906 | Product name | 7 | 20210625 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| 11ed6f83-cdd2-4637-8379-b1a1d3ae3cde | Product name | 1 | 20181101 |
| 86c45a79-b9f0-4476-a27c-6e10db098497 | Product name | 1 | 20180125 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 84415-014-01 | Dextromethorphan HBr. and Guaifenesin | 5 mL in 1 CUP, UNIT-DOSE | SOLUTION | 5 | 1 | |
| 84415-014-01 | Dextromethorphan HBr. and Guaifenesin | 100 in 1 BOX, UNIT-DOSE | SOLUTION | 100 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 84415-014-01 | ML - Milliliter | 84415-014 | 694de038-b9ae-4341-a9aa-ffaa1d2a0eee | 1 | 2025-11-13 |
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 |
|---|---|---|---|---|---|---|
| Levmetamfetamine | LEVMETAMFETAMINE | Meijer, Inc. | d11e916f-90a6-4099-bf83-75f2dfbd6266 | 2024-12-20 | Warnings | M012 |
| Vapor Inhaler levmetamfetamine nasal decongestant, DG health | LEVMETAMFETAMINE | Dolgencorp Inc. | 5dbc5a2d-feae-40d8-a8d4-1d6155a1bbd3 | 2024-12-20 | Warnings | M012 |
| Tukol Multi Symptom Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Genomma Lab USA, Inc. | aef2ad43-145d-4abc-bccc-2c5fdd6882f9 | 2024-12-20 | Warnings | M012 |
| Vapor Inhaler levmetamfetamine nasal decongestant, TopCare health | LEVMETAMFETAMINE | Topco Associates LLC | 8f995561-759a-4837-a82a-640417a6f889 | 2024-12-20 | Warnings | M012 |
| Childrens Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN | Wal-Mart Stores, Inc. | 50a0eaa5-fa73-4d84-86fc-3546c85cf353 | 2024-12-20 | Warnings | M012 |
| Equate Childrens Multi symptom Cold Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Wal-Mart Stores, Inc. | bfdaec98-24fe-47e1-ad32-dc2ddc4ce8ee | 2024-12-20 | Warnings | M012 |
| Vapor Inhaler | LEVMETAMFETAMINE NASAL DECONGESTANT | C.D.M.A., Inc. | 904b7e21-cce5-4b96-afc1-b36f532f98ac | 2024-12-20 | Warnings | M012 |
| Vapor Inhaler levmetamfetamine nasal decongestant, Equaline | LEVMETAMFETAMINE | Supervalu Inc. | 44f72f34-d0b8-421f-b240-86286de874cf | 2024-12-20 | Warnings | M012 |
| Childrens Tussnex | ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Guardian Drug Company | 19e9678d-ac34-4af8-a80f-d08fce0a5f0e | 2024-12-19 | Warnings | M012 |
| Vaporising Chest Rub | CAMPHOR, MENTHOL, EUCALYPTUS OIL | New Pride Corp | f66476d5-036b-0b1c-e053-2a95a90a0a07 | 2024-12-19 | Warnings | M012 |
| Chest Rub Vaporizing Action | MENTHOL AND CAMPHOR AND EUCALYPTUS OIL | Singhfam Corporation | c6ea663a-9c4f-4d1a-a937-002806a8530a | 2024-12-19 | Warnings | M012 |
| ELIZABETH HEALTH STYLE CHESTRUB VAPORIZING ACTION | CAMPHOR (SYNTHETIC), LEVOMENTHOL, EUCALYPTUS | Singhfam Corporation | f1e4caee-b50e-a0a6-e053-2a95a90aadce | 2024-12-19 | Warnings | M012 |
| Leader Vapor Steam camphor (synthetic) | CAMPHOR (SYNTHETIC) | LEADER/Cardinal Health 110, Inc. | ae580e6c-2efd-c788-e053-2995a90a3360 | 2024-12-19 | Warnings | M012 |
| Tussin DM | DEXTROMETHORPHAN HBR, GUAIFENESIN | Strategic Sourcing Service, LLC | 0b6689db-ea34-9a06-e063-6394a90abaf7 | 2024-12-19 | Warnings | M012 |
| Medicated Chest Rub | CAMPHOR, MENTHOL, EUCALYPTUS OIL | Jell Pharmaceuticals Pvt Ltd. | d80b9cc1-55f5-76d5-e053-2995a90aa967 | 2024-12-19 | Warnings | M012 |
| Health Smart Vaporizing Chest Rub | MENTHOL AND CAMPHOR AND EUCALYPTUS OIL | Home Smart Products | acab200e-48bd-69e1-e053-2995a90afde0 | 2024-12-19 | Warnings | M012 |
| Halls MENTHO-LYPTUS | MENTHOL | Mondelez Global LLC | ff21cf0e-9811-4819-bdfc-17a950e9b114 | 2024-12-19 | Warnings | M012 |
| Tussnex FM Cold, Flu and Sore Throat | ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Guardian Drug Company | 7bddce11-c227-4d95-94c1-6f41ecd7285b | 2024-12-19 | Warnings | M012 |
| Childrens Tussnex Multi-symptom cold | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Guardian Drug Company | 9028676e-d725-4afe-aa14-72235825aa17 | 2024-12-19 | Warnings | M012 |
| Tussnex FM Cold and Sinus | ACTEAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Guardian Drug Company | 04c6bb6a-d2f8-4322-afba-e240e8090176 | 2024-12-19 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 996520 | dextromethorphan HBr 20 MG / guaiFENesin 200 MG in 10 mL Oral Solution | PSN | 0c7cd5c4-459d-4e42-ae22-b94f2e29cffb | 1 |
| 996520 | dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML Oral Solution | SCD | 0c7cd5c4-459d-4e42-ae22-b94f2e29cffb | 1 |
| 996520 | dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG per 5 ML Oral Solution | SY | 0c7cd5c4-459d-4e42-ae22-b94f2e29cffb | 1 |
| 996520 | dextromethorphan hydrobromide 15 MG / guaifenesin 150 MG per 7.5 ML Oral Solution | SY | 0c7cd5c4-459d-4e42-ae22-b94f2e29cffb | 1 |
| 996520 | dextromethorphan hydrobromide 20 MG / guaifenesin 200 MG per 10 ML Oral Solution | SY | 0c7cd5c4-459d-4e42-ae22-b94f2e29cffb | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 84415-014-01 | 84415001401 | 100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (84415-014-01) / 5 mL in 1 CUP, UNIT-DOSE | 2025-01-16 | No | No | Current |