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 |
|---|---|---|---|---|---|---|
| Defensol D Blister Pack | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCI | Menper Distributors, Inc. | 0dfcc977-6101-4536-e063-6294a90a7a48 | 2025-07-22 | Warnings | M012 |
| Broncofin | DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Menper Distributors, Inc. | fdf67382-1692-485b-92f1-2cbb8be4fb70 | 2025-07-22 | Warnings | M012 |
| Defensol Adult Syrup | GUAIFENESIN, DEXTROMETHORPHAN HBR | Menper Distributors, Inc. | 62acff69-8c40-4a0e-8d56-be2cc14e3d45 | 2025-07-22 | Warnings | M012 |
| Cosedal Drops | DEXTROMETHORPHAN HBR, GUAIFENESIN | Menper Distributors, Inc. | 1241d249-ea3b-4d2b-87ed-835d6a2d286a | 2025-07-22 | Warnings | M012 |
| Berro y Cebolla DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Menper Distributors, Inc. | 20107bd9-6d84-4ab5-a0d9-966f1f11d919 | 2025-07-22 | Warnings | M012 |
| Defensol-ito | DEXTROMETHORPHAN, GUIAFENESIN, PHENYLEPHRINE | Menper Distributors, Inc | a7c7a60d-d49f-4239-92f7-714eac7eb0c5 | 2025-07-22 | Warnings | M012 |
| Bisolvine Children | GUAIFENESIN, DEXTROMETHORPHAN | MENPER DISTRIBUTORS INC. | 896a5443-e3d2-4af7-9e27-f1c1899ce038 | 2025-07-22 | Warnings | M012 |
| Bisolvine Aloe-Miel | DEXTROMETHORPHAN, GUAIFENESIN | MENPER DISTRIBUTORS INC. | 34801c79-ce88-492f-808e-b639e8601607 | 2025-07-22 | Warnings | M012 |
| Viva Porru Chest Rub | CAMPHOR, MENTHOL, EUCALYPTUS OIL | Menper Distributors, Inc. | 0dfadfe3-9e40-0eee-e063-6294a90a00c3 | 2025-07-22 | Warnings | M012 |
| leader childrens allergy relief | DIPHENHYDRAMINE HCL | Cardinal Health 110, LLC. dba Leader | 40d697b7-dc59-4d24-8d46-db635e01b9d5 | 2025-07-22 | Warnings | M012 |
| Allergy Relief | CHLORPHENIRAMINE MALEATE | Chain Drug Consortium | 34005c55-3176-4f28-9a3b-7dc6fefd01fe | 2025-07-19 | Warnings | M012 |
| Sinus Relief Daytime Nighttime | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HCL | Kroger Company | 73a77a13-983b-4e65-bb3c-2ba5e9f33a3e | 2025-07-19 | Warnings | M012 |
| QUALITY CHOICE No Drip Nasal Mist | OXYMETAZOLINE HYDROCHLORIDE | QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) | 7cb6ad04-7847-46b9-b371-0a3473001c79 | 2025-07-18 | Warnings | M012 |
| Nasal Decongestant Maximum Strength | PSEUDOEPHEDRINE HCL | Chain Drug Consortium | 270e9221-d305-4148-b523-741e02fe733f | 2025-07-18 | Warnings | M012 |
| ACTISPEC PSE | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE | ACTIPHARMA, LLC | 5def1555-87f4-41d5-8a5c-be560aa8f1e2 | 2025-07-17 | Warnings | M012 |
| EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY | ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE | Kenvue Brands LLC | 1a17b24a-8022-4e2f-e063-6294a90af276 | 2025-07-17 | Warnings | M012 |
| BULPOL Smoking Patches | MENTHOL | Jiashen International Trade Limited | 3a1cc0e1-fabf-52b9-e063-6394a90ae35e | 2025-07-17 | Warnings | M012 |
| Ampigrin Ultra Forte Night | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | OPMX LLC | e11e71c3-fe7c-77c7-e053-2995a90a34b2 | 2025-07-17 | Warnings | M012 |
| Nitecin | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | OPMX LLC | dfb56532-6f72-1e4d-e053-2a95a90a1c05 | 2025-07-17 | Warnings | M012 |
| tabcin NIGHT | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | OPMX LLC | 0b3ed2bb-88ed-699e-e063-6394a90ac023 | 2025-07-17 | 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 |