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 |
|---|---|---|---|---|---|---|
| Afrin Original Pump Mist | OXYMETAZOLINE HYDROCHLORIDE | Bayer HealthCare LLC. | 0f5ec576-f788-40aa-9088-0dd672e3cc7c | 2025-12-04 | Warnings | M012 |
| Adult Long Lasting Cough Relief | DEXTROMETHORPHAN HBR | Shield Pharmaceuticals Corp | 432a79a9-c69d-4514-894a-7832e1b745ef | 2025-12-04 | Warnings | M012 |
| GENCONTUSS | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | KRAMER NOVIS | 69d16d25-b09b-430e-8e01-0962d840dc21 | 2025-12-04 | Warnings | M012 |
| Nasal Decongestant PE | PHENYLEPHRINE HCL | H E B | 7c04ab14-af28-4598-90ef-56ac11902c7d | 2025-12-04 | Warnings | M012 |
| Desgen Pediatric | DEXTROMETHORPHAN HBR, GUIAFENESIN, PHENYLEPHRINE HCL | Kramer Novis | 12425c1b-8bdc-446b-83dd-95e05a4d9b8c | 2025-12-04 | Warnings | M012 |
| Presgen B | DEXTROMETHORPHAN HYDROBROMIDE, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE | KRAMER NOVIS | 5befa829-32bd-4978-8a0e-1d6513ff37a4 | 2025-12-03 | Warnings | M012 |
| TUSSLIN | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Kramer Novis | 987e19a5-032f-44e9-b4c7-8a764d502695 | 2025-12-03 | Warnings | M012 |
| DayTime Relief, Cold and Flu, 24-7 Life by 7-Eleven | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL SOLUTION | Lil' Drug Store Products, Inc. | 450e8974-8ff8-4b82-e063-6394a90a9366 | 2025-12-03 | Warnings | M012 |
| Nighttime Relief, Cold and Flu, 24-7 Life by 7-Eleven | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE SOLUTION | Lil' Drug Store Products, Inc. | 4510223f-1c88-2796-e063-6394a90a18ac | 2025-12-03 | Warnings | M012 |
| Carolina Crud Crusher | DEXTROMETHORPHAN HBR, GUAIFENESIN | Weeks & Leo Co., Inc. | 0b606683-7d68-cca5-e063-6394a90a6f58 | 2025-12-03 | Warnings | M012 |
| Capmist DM | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE | Capital Pharmaceutical, LLC | 63733ac3-859e-4a8e-8717-d852bd303408 | 2025-12-03 | Warnings | M012 |
| ALA-HIST IR | DEXBROMPHENIRAMINE MALEATE | Poly Pharmaceuticals, Inc. | 0d203b5c-8b10-428b-8703-17be6b4ce6eb | 2025-12-03 | Warnings | M012 |
| ALAHIST DM | DEXTROMETHORPHAN HBR, PHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Poly Pharmaceuticals, Inc. | fdaa062d-110e-798d-e053-6394a90a755c | 2025-12-03 | Warnings | M012 |
| Alahist D | PHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Poly Pharmaceuticals, Inc. | a1b8533a-ef8b-57cc-e053-2995a90a5d9e | 2025-12-03 | Warnings | M012 |
| Alahist PE | DEXBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE | Poly Pharmaceuticals, Inc. | ada2d582-5813-2029-e053-2a95a90ae567 | 2025-12-03 | Warnings | M012 |
| Benadryl Allergy Extra Strength Liqui-Gels | DIPHENHYDRAMINE HYDROCHLORIDE | Kenvue Brands LLC | 30aca3ab-b091-3939-e063-6294a90a9819 | 2025-12-03 | Warnings | M012 |
| Cough and Cold HBP | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | L.N.K. International, Inc. | 9f2daffc-1904-4d64-9f84-689c88601e06 | 2025-12-03 | Warnings | M012 |
| Childrens Multi-symptom Cold | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Wal-Mart Stores, Inc. | d291faa9-894e-421c-8115-8a8c2a937172 | 2025-12-03 | Warnings | M012 |
| SINUS PAIN AND CONGESTION | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | CVS Pharmacy | 697dffdd-5b56-4395-8e69-6b4360d9fdc5 | 2025-12-02 | Warnings | M012 |
| Maximum Strength Mucus Relief Severe Congestion and Cough | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores,Inc., | 9c8c1974-f931-4493-abb5-ecdc32764ab3 | 2025-12-02 | 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 |