DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN
- Product NDC
- 69729-062
- 11-digit product format
- 697290062
- Labeler code
- 69729
- Product ID
- 69729-062_5d203e0a-2498-6041-e063-6294a90a885b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- OPMX LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-02-01
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
- Active strength
- 20; 300 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
- 2027-12-31
- 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 HYDROBROMIDE and GUAIFENESIN
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/5mL |
| GUAIFENESIN | 300 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 |
| 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69729-062-04 | DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN | 118 mL in 1 BOTTLE | SYRUP | 118 | 7 |
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 |
|---|---|---|---|---|---|---|
| Tussnex FM Severe cough and congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Guardian Drug Company | 387df403-7803-4031-915e-8de9b103a162 | 2024-12-19 | Warnings | M012 |
| Maximum strength Tussnex FM DM Max | DEXTROMETHORPHAN HBR, GUAIFENESIN | Guardian Drug Company | 0bae53e3-9661-4bc6-9fcc-da7fa131b034 | 2024-12-19 | Warnings | M012 |
| Vicks Vaposteam Lavender | CAMPHOR, (-)- | Kaz USA, Inc | 03bf6b78-cf8e-44c6-bae0-5bd0a85f8aa9 | 2024-12-19 | Warnings | M012 |
| Refenesen Mucus Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Reese Pharmaceutical Co | 6046dc50-f162-4e2d-aa3c-7d27efad477d | 2024-12-18 | Warnings | M012 |
| Sunmark Chest Congestion Relief PE PE | GUAIFENESIN/PHENYLEPHRINE | Strategic Sourcing Services LLC | f94ae469-4c79-4ce9-9a3d-3bdc645be6d9 | 2024-12-18 | Warnings | M012 |
| Quality Choice Mucus Relief DM DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Chain Drug Marketing Association | 1c33a01f-1186-4a19-b639-a9cd49245220 | 2024-12-18 | Warnings | M012 |
| HealthMart Chest Congestion Relief | GUAIFENESIN | Strategic Sourcing Services LLC | a5d1a8e8-10ba-4fff-b6f7-18c0fde5155c | 2024-12-18 | Warnings | M012 |
| DG Health Immediate Release Mucus Relief | GUAIFENESIN | Reese Pharmaceutical Co | f60a9d1b-7a63-43d3-b843-e1f31cf78873 | 2024-12-18 | Warnings | M012 |
| Health Smart Vaporizing Chest Rub | MENTHOL AND CAMPHOR AND EUCALYPTUS OIL | Jell Pharmaceuticals Pvt Ltd. | d80cad8d-da4c-049d-e053-2a95a90ac20e | 2024-12-18 | Warnings | M012 |
| Afrin Original | OXYMETAZOLINE HYDROCHLORIDE | Lil' Drug Store Products, Inc. | 8a97c012-6a47-4607-9389-58a4eed17b08 | 2024-12-18 | Warnings | M012 |
| Medicated Chest Rub | CAMPHOR, MENTHOL, EUCALYPTUS OIL | Orazen Inc | ecddaa3b-e18f-1c74-e053-2995a90ad86a | 2024-12-18 | Warnings | M012 |
| Rite Aid Chest Rub | CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL | Rite Aid | dfedbef1-8062-432d-e053-2a95a90a09e9 | 2024-12-18 | Warnings | M012 |
| TheraCare Medicated Chest Rub | CAMPHOR, MENTHOL, EUCALYPTUS OIL | Veridian Healthcare | f7801843-f96c-710e-e053-6294a90a5086 | 2024-12-18 | Warnings | M012 |
| Rugby Chest Congestion Relief G450 | GUAIFENESIN | Rugby Laboratories | a6aa8cbd-21ff-4f84-b338-c05c2d46e6df | 2024-12-18 | Warnings | M012 |
| Refenesen Mucus Relief | GUAIFENESIN | Reese Pharmaceutical Co | 861dffb7-8bf4-4f03-bcc2-ed8a35bc341d | 2024-12-18 | Warnings | M012 |
| Marcs Chest Congestion Relief DM | DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN | Marc Glassman Inc | be3ad54f-522c-440d-b8c7-9664f6015566 | 2024-12-18 | Warnings | M012 |
| Chest Congestion Relief | GUAIFENESIN | Strategic Sourcing Services LLC | da6bd9df-aebe-4fe5-b20b-01bda3b9e7ee | 2024-12-18 | Warnings | M012 |
| Family Wellness Chest Congestion Relief | GUAIFENESIN | Family Dollar Services Inc | 412f3459-4c22-4822-86bd-011fc3e91ca6 | 2024-12-18 | Warnings | M012 |
| Marcs Mucus Relief | GUAIFENESIN | Marc Glassman Inc | 455b9f01-206c-4534-a006-292d2bd48f47 | 2024-12-18 | Warnings | M012 |
| Leader Chest Congestion Relief G450 | GUAIFENESIN | Cardinal Health | 4586a83f-077c-4fb3-adfe-7a9497a78d97 | 2024-12-18 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1117394 | dextromethorphan HBr 20 MG / guaiFENesin 300 MG in 5 mL Oral Solution | PSN | 826c2f47-00a6-4060-a7ad-1ef26ccfddd1 | 7 |
| 1117394 | dextromethorphan hydrobromide 4 MG/ML / guaifenesin 60 MG/ML Oral Solution | SCD | 826c2f47-00a6-4060-a7ad-1ef26ccfddd1 | 7 |
| 1117394 | dextromethorphan hydrobromide 20 MG / guaifenesin 300 MG per 5 ML Oral Solution | SY | 826c2f47-00a6-4060-a7ad-1ef26ccfddd1 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69729-062-04 | 69729006204 | 118 mL in 1 BOTTLE (69729-062-04) | 118 ml | 2021-02-01 | 0000-00-00 | No | No | Current |