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 |
|---|---|---|---|---|---|---|
| Sinus and Headache Daytime | ACETAMINOPHEN, PHENYLEPHRINE HCL | DOLGENCORP, LLC | 869e950c-5861-4840-aaad-b0342790d62b | 2026-02-10 | Warnings | M012 |
| CareOne Night TIme Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | American Sales Company | d6b9fb27-3ef7-47ee-81f2-b9a3ccd6de25 | 2026-02-10 | Warnings | M012 |
| Medique Cold Cough Product | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL , | Sportpharm LLC | d61df3a4-8ae2-46b1-b322-7f4e04cc1bf9 | 2026-02-09 | Warnings | M012 |
| Sinus Congestion and Pain Daytime | ACETAMINOPHEN AND PHENYLEPHRINE HCL | United Natural Foods, Inc. dba UNFI | f3fc270a-92fc-46d5-b187-44e875c3abb9 | 2026-02-09 | Warnings | M012 |
| Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | L.N.K. International, Inc. | d5c8b248-6d82-4eac-881c-0b9d0a0de8f1 | 2026-02-09 | Warnings | M012 |
| DayTime/NiteTime Severe Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Meijer Distribution Inc | d07112dd-27df-46cc-b7c3-af8ba7601d06 | 2026-02-09 | Warnings | M012 |
| TYLENOL Cold Plus Flu Multi-Symptom Liquid Gels Day Plus Night | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE | Kenvue Brands LLC | 48f7933e-6582-638c-e063-6394a90abfe5 | 2026-02-06 | Warnings | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Retail Business Services, LLC | 4fb46860-2bf9-41a7-89eb-31c259c61107 | 2026-02-06 | Warnings, Adverse reactions | M012 |
| pseudoephedrine hydrochloride | PSEUDOEPHEDRINE HCL | Sportpharm LLC | 909dacfa-50d3-4bcf-b2df-5405427cfaad | 2026-02-06 | Warnings | M012 |
| Good Sense Nasal | OXYMETAZOLINE HYDROCHLORIDE | Sportpharm LLC | f91b7c1f-e074-4767-b9c8-dbf1937a6a0f | 2026-02-06 | Warnings | M012 |
| Severe Allergy And Sinus Headache Maximum Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | CVS Pharmacy | b3c744b8-aa93-505d-f8cf-07995da4283d | 2026-02-06 | Warnings | M012 |
| NightTime Cold and Flu Multi Symptom | ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DOXYLAMINE SUCCINATE | WinCo Foods, LLC | 911e6a51-c0f0-491a-b70c-00011ed5e35b | 2026-02-06 | Warnings | M012 |
| Severe Sinus Daytime, Non-Drowsy | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreen Company | cc0dc951-5024-4517-9d38-a01699407e7e | 2026-02-06 | Warnings | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Pharmacy Value Alliance, LLC | d836c3e2-3b69-41f3-b166-21270550e8ab | 2026-02-05 | Warnings, Adverse reactions | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Publix Super Markets, Inc. | 81b1d5bb-f813-4f79-9559-2494db33ad3c | 2026-02-05 | Warnings, Adverse reactions | M012 |
| Nasal | OXYMETAZOLINE HYDROCHLORIDE | Kroger Company | 6499f854-2995-48cb-9c80-be6524b3db43 | 2026-02-05 | Warnings | M012 |
| Cold and Flu plus Congestion Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | WALMART INC. | 52a398eb-e593-458b-9c42-6f653ca391be | 2026-02-04 | Warnings | M012 |
| Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Hy-Vee, Inc. | 446de381-6685-748d-e063-6394a90a1b73 | 2026-02-04 | Warnings, Adverse reactions | M012 |
| Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | 85aadc86-d979-41a1-849a-e2ccc9014429 | 2026-02-04 | Warnings | M012 |
| severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | HyVee Inc | fa8c154c-56c6-47de-8e43-9e012b4be95f | 2026-02-04 | 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 |