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 |
|---|---|---|---|---|---|---|
| Childrens Delsym Cough Plus Cold Night Time | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 00689aa5-ed39-4c9a-92b8-105d2c0e2e15 | 2026-05-27 | Warnings | M012 |
| Childrens Delsym Cough Plus Chest Congestion DM and Delsym Cough Plus Cold Night Time | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HYDROCHLORIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 9aca1a68-893c-4770-8a48-d5d678058253 | 2026-05-27 | Warnings | M012 |
| Childrens Delsym Cough Plus Chest Congestion DM | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Reckitt Benckiser LLC | d26b5143-aa07-4114-a6ba-4f503aadd46f | 2026-05-27 | Warnings | M012 |
| Goodmeds Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Cabinet Health P.B.C. | 37533188-8c91-428b-a796-c5afd9e4959f | 2026-05-27 | Warnings | M012 |
| Delsym Cough Plus Chest Congestion DM | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Reckitt Benckiser LLC | 8252cdec-b668-4450-b045-e093479ab542 | 2026-05-27 | Warnings | M012 |
| Delsym Nighttime Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 27f9d2db-38ce-41d2-8f1a-0eb171600274 | 2026-05-27 | Warnings | M012 |
| Delsym Cough Plus Sore Throat | ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | b37b786e-0cce-419d-94ed-3b64a1eb1201 | 2026-05-27 | Warnings | M012 |
| Delsym Cough | DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | a43d59f9-3a6c-4a7c-b98d-b86d6035f716 | 2026-05-27 | Warnings | M012 |
| Cold and Flu Relief Severe Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Rite Aid Corporation | 5700ef26-ffa6-480a-bf36-bd5111799e9b | 2026-05-27 | Warnings | M012 |
| Air Power | GUAIFENESIN | Schwabe North America, Inc | 5cdefc7a-6242-4681-88a3-04422a1d48d3 | 2026-05-27 | Warnings | M012 |
| Cold and Flu Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL | WALMART INC. | adb658c8-db8d-4db6-80c8-e0f2de88a2de | 2026-05-27 | Warnings | M012 |
| Daytime Cold and Flu Non Drowsy | ACETAMINOHPEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | CVS Pharmacy | c71427d4-707f-411f-8bd4-133517a9992b | 2026-05-26 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL | CVS PHARMACY, INC | 643e929d-9e62-4260-91ee-e88a184dd7cd | 2026-05-26 | Warnings | M012 |
| TopCare Day Time Nite Time Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Topco Associates LLC | c00ff684-acaf-4fbe-bc74-7e48751b927d | 2026-05-26 | Warnings | M012 |
| Goodmeds Non-Drowsy Nasal Decongestant PE | PHENYLEPHRINE | Cabinet Health P.B.C. | 4e75da23-35f2-431c-92cb-c2c4cb3f09f1 | 2026-05-26 | Warnings | M012 |
| Night Time Cold and Flu Relief Multi Symptom | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | CVS Pharmacy | 13492631-d5de-4562-a201-664f7d3591de | 2026-05-26 | Warnings | M012 |
| Sinufrin Decongestant | NASAL CONGESTION RELIEF | NeilMed Pharmaceuticals Inc | 52a2e5f9-e0a2-02f7-e063-6294a90a3ae9 | 2026-05-25 | Warnings | M012 |
| Cough Suppressant Adult | DEXTROMETHORPHAN HYDROBROMIDE | Rugby Laboratories | 47b713bd-4c1e-f44a-e063-6294a90a63d3 | 2026-05-25 | Warnings | M012 |
| ClorRelief | CHLORPHENIRAMINE MALEATE | FERRER MEDICAL INNOVATIONS LLC | db729011-f72f-5911-e053-2a95a90a68bf | 2026-05-22 | Warnings | M012 |
| Childrens Dye Free Allergy Relief | DIPHENHYDRAMINE HCL | Rite Aid Corporation | 74ff4f0d-7952-4b74-b1b2-5a2beab91f7c | 2026-05-22 | 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 |