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 |
|---|---|---|---|---|---|---|
| Topcare childrens allergy | DIPHENHYDRAMINE HYDROCHLORIDE | Topco Associates LLC | 6b784cde-3152-4421-a825-dd1fc601aa7a | 2024-07-17 | Warnings | M012 |
| Mucus Relief Severe Congestion and Cough Maximum Strength | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Walgreens | 4c6b6379-3a7f-4507-a792-7b69a7f3ba82 | 2024-07-17 | Warnings | M012 |
| Mucus Relief Cold Flu Sore Throat Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Walgreens | 04defcf6-e20e-402b-b725-d9394a0146b1 | 2024-07-16 | Warnings | M012 |
| basic care allergy relief | DIPHENHYDRAMINE HYDROCHLORIDE | Amazon.com Services LLC | 7d237d37-21c7-476d-a8b7-d91ea1b472ee | 2024-07-16 | Warnings | M012 |
| Berkley and Jensen Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | BJWC | b52fc311-8853-4116-941b-8be35456abba | 2024-07-16 | Warnings | M012 |
| Mucus Relief All In One Daytime Nighttime Cold Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DIPHENHYDRAMINE HCL PHENYLEPHRINE HCL | Walgreens | 0b9a4438-7d13-484c-a614-2dedc24974dc | 2024-07-16 | Warnings | M012 |
| allergy | DIPHENHYDRAMINE HYDROCHLORIDE | Publix Super Markets Inc | 23a98385-28cc-4fac-8c87-b3ced8106532 | 2024-07-16 | Warnings | M012 |
| Walgreens Moisturizing Ultra Fine Mist with Aloe | 0.05% OXYMETAZOLINE | Walgreens Company | aad01028-cbe0-4c10-adbc-d157bfa5af09 | 2024-07-16 | Warnings | M012 |
| Basic Care severe cold and cough | ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE | Amazon.com Services LLC | 924bf427-b054-46af-b341-ff162946cd58 | 2024-07-15 | Warnings | M012 |
| Maximum Strength Cold Tabs | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | JHK DBA American Safety & First Aid | e7d4fe9a-eb09-4266-90c9-290f61ce6ad0 | 2024-07-15 | Warnings | M012 |
| ACTIDOM DA | CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE | ACTIPHARMA, LLC | 7797c22e-ffeb-4798-9fb6-aa64cf077ba7 | 2024-07-15 | Warnings | M012 |
| Nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | TARGET CORPORATION | 1cf3064d-4ddd-63b9-e063-6294a90aa547 | 2024-07-11 | Warnings | M012 |
| Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HCL | TARGET CORPORATION | 1ccbdb53-3f70-28da-e063-6394a90a9ae0 | 2024-07-09 | Warnings | M012 |
| AXIV Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | VIVUNT PHARMA LLC | 1cd2a6f1-31ad-e507-e063-6394a90aba58 | 2024-07-09 | Warnings | M012 |
| Poly Hist Forte | DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE | Poly Pharmaceuticals, Inc. | 8aa0015b-8fc1-7951-e053-2a95a90a8e72 | 2024-07-09 | Warnings | M012 |
| DECONEX DMX | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Poly Pharmaceuticals, Inc. | 8aab8e5c-1633-2e5a-e053-2a95a90adcc5 | 2024-07-09 | Warnings | M012 |
| Deconex IR | GUAIFENESIN AND PHENYLEPHRINE HCL | Poly Pharmaceuticals, Inc. | 4710095e-3dae-4a39-8a98-873012e1f003 | 2024-07-09 | Warnings | M012 |
| Diabetic Tussin Sore Throat and Cough Cherry | BENZOCAINE AND DEXTROMETHORPHAN HBR | MEDTECH PRODUCTS INC | e9327079-e0fc-4c95-b1d5-bc1b74870c9b | 2024-07-09 | Warnings | M012 |
| nasal | OXYMETAZOLINE HYDROCHLORIDE | Rite Aid Corporation | fac859a4-e23a-4879-af6c-26368455506d | 2024-07-05 | Warnings | M012 |
| Severe Throat Drops | MENTHOL ICE | Target Corporation Inc. | 1876b221-fa60-5269-e063-6394a90a6963 | 2024-07-04 | 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 |