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 |
|---|---|---|---|---|---|---|
| MGC Health Cough Drops Honey Herb | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 3fa17272-fd7f-9ab4-e063-6394a90a585f | 2025-09-25 | Warnings | M012 |
| MGC Health Throat Soothing Drops Creamy Strawberry | PECTIN | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 3fa2e438-2ff3-a2df-e063-6394a90ac7b5 | 2025-09-25 | Warnings | M012 |
| QUALITY CHOICE ADULT TUSSIN EXPECTORANT | GUAIFENESIN | QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) | 63dad603-fe2f-42a6-a626-5c8048a42c10 | 2025-09-25 | Warnings | M012 |
| Giltuss Childrens Allergy Plus | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Dextrum Laboratories Inc. | 3fa5220f-38bb-9ef6-e063-6294a90aeff8 | 2025-09-25 | Warnings | M012 |
| Acetaminophen 325 mg, Dextromethorphan Hydrobromide 10 mg, Phenlyephrine Hydrochloride 5 mg softgel (DAY-TIME) | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Health Pharma USA LLC | a03befb4-d86d-43e4-8097-eda5c8bb25be | 2025-09-24 | Warnings | M012 |
| Childrens Giltuss EX Expectorant | GUAIFENESIN | Dextrum Laboratories Inc. | 3f8d7d47-f14c-888c-e063-6394a90a5cdd | 2025-09-24 | Warnings | M012 |
| Childrens Giltuss Honey Cough and Chest Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | Dextrum Laboratories, Inc | 3f909bc2-eb84-a19d-e063-6294a90ae04e | 2025-09-24 | Warnings | M012 |
| Giltuss Honey DM Cough | DEXTROMETHORPHAN HBR | Dextrum Laboratories, Inc | 3f79137f-f0b0-d22c-e063-6394a90a7245 | 2025-09-23 | Warnings | M012 |
| GoodSense Medicated Chest Rub | CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL | GOOD SENSE | 240bb6af-9d38-49fe-9011-3016246b0986 | 2025-09-23 | Warnings | M012 |
| Xpect Honey Lemon Cough Drops | HONEY LEMON COUGH DROPS | Cintas Corporation | 79e0b7c1-4acc-41d2-89cd-d075a8bac0c9 | 2025-09-23 | Warnings | M012 |
| Topcare NiteTime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Topco Associates LLC | b2b3c450-e988-41d1-9e53-cc8e30d75cb4 | 2025-09-23 | Warnings | M012 |
| Xpect Cherry Cough Drops | CHERRY COUGH DROPS | Cintas Corporation | d1fd2f23-5435-405d-a7fd-644691f79e80 | 2025-09-23 | Warnings | M012 |
| Topcare DayTime NiteTime Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Topco Associates LLC | 560fb22b-391f-4d7b-a6fd-38d577d404b0 | 2025-09-23 | Warnings | M012 |
| Giltuss EX Expectorant | GUAIFENESIN | Dextrum Laboratories Inc. | 3f67ac3d-1503-3418-e063-6394a90a938f | 2025-09-22 | Warnings | M012 |
| Giltuss HBP Cough and Chest Congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Dextrum Laboratories Inc. | 3f68e68a-cf32-9df8-e063-6394a90a3012 | 2025-09-22 | Warnings | M012 |
| SUPRESS A | DEXBROMOPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Kramer Novis | f0bec5f5-4d76-471e-9024-557eba848b93 | 2025-09-22 | Warnings | M012 |
| RIGHT REMEDIES NIGHTTIME SEVERE COLD AND FLU softgel | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Strive Pharmaceuticals Inc. | 9f050fb0-6100-4b14-b82f-1d5fcbf16540 | 2025-09-22 | Warnings | M012 |
| RIGHT REMEDIES DAYTIME SEVERE COLD AND FLU softgel | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Strive Pharmaceuticals Inc. | c6392ace-c7d1-4450-8b71-4dccc60b4f02 | 2025-09-22 | Warnings | M012 |
| Giltuss Cough and Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Dextrum Laboratories Inc. | 3f12ee8f-d1c6-d73a-e063-6394a90a9199 | 2025-09-18 | Warnings | M012 |
| CVS Diphenhydramine Hydrochloride | DIPHENHYDRAMINE HYDROCHLORIDE | CVS Pharmacy | 3d71d306-893a-e73a-e063-6394a90a0a3b | 2025-09-18 | 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 |