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 |
|---|---|---|---|---|---|---|
| Alka-Seltzer Plus Severe Cold Night PowerFast Fizz | ASPIRIN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | c1fae6c7-bbac-1320-e053-2a95a90aac5a | 2026-01-08 | Warnings | M012 |
| Alka-Seltzer Plus Night Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | f4c60ca1-ba59-4a92-84a5-6ba65faa56ab | 2026-01-08 | Warnings | M012 |
| Alka-Seltzer Plus Day Severe Cold Plus Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | cec51eab-cce3-4965-a14e-a46d953050c4 | 2026-01-08 | Warnings | M012 |
| VanaCof 2 | CHLOPHEDIANOL HCL, DEXCHLORPHENIRAMINE MALEATE | GM Pharmaceuticals, INC | 0c7c6756-abb2-c10c-e063-6394a90a9863 | 2026-01-08 | Warnings | M012 |
| VANACOF XP Cough / Chest Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | GM Pharmaceuticals, INC | 0b3a8cc1-a49f-e1e5-e063-6394a90a1c06 | 2026-01-08 | Warnings | M012 |
| Diphenhydramine HCl | DIPHENHYDRAMINE HCL | INVAHEALTH INC | e4e4004f-77e3-569d-e053-2a95a90a73fe | 2026-01-08 | Warnings | M012 |
| Robitussin Maximum Strength Cough Plus Chest Congestion DM | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | Haleon US Holdings LLC | 868ac65a-63e2-46ac-b87d-66b289086756 | 2026-01-08 | Warnings | M012 |
| Theraflu Flu Relief Max Strength Daytime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | 0324195f-506d-4747-990e-ad44e2a117d9 | 2026-01-07 | Warnings | M012 |
| Sambrosa Night | DOXYLAMINE SUCCINATE | Sambrosa Care, Inc. | acdc8740-6231-d1e8-e053-2995a90a3b8d | 2026-01-07 | Warnings | M012 |
| VAPOREX | CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL | DLC Laboratories, Inc. | 971943b1-4199-4f75-9d2d-61242d346b5f | 2026-01-07 | Warnings | M012 |
| BACTIMICINA COUGH AND COLD | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | DLC Laboratories, Inc. | 2e612c62-9bbb-45f2-a253-aa2bfaeaac70 | 2026-01-07 | Warnings | M012 |
| Earths Care Chest Rub | CAMPHOR, EUCALYPTUS OI, MENTHOL | DLC Laboratories, Inc | 2424f5d5-1772-96f1-e063-6294a90a89ee | 2026-01-07 | Warnings | M012 |
| Bactimicina Vapor Rub | VAPOR RUB | DLC Laboratories, Inc. | 176b617a-faf6-7893-e063-6294a90a046b | 2026-01-07 | Warnings | M012 |
| Sinus Pressure and Pain | ACETAMINOPHEN, PHENYLEPHRINE HCL | Family Dollar Services Inc | 0d3e4ceb-5059-4aac-8aa2-bf714ca9deb2 | 2026-01-07 | Warnings | M012 |
| Tussin Multi Symptom Cold CF | DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCL | QUALITY CHOICE (Chain Drug Marketing Association) | b225e897-5728-4519-b727-c0f361c75976 | 2026-01-07 | Warnings | M012 |
| Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Walgreen Company | 80b218f7-66bb-4e15-a0dc-ec9b6af1b056 | 2026-01-07 | Warnings | M012 |
| tussin cough and chest congestion | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Rite Aid Corporation | 13618054-d0c5-4190-b626-e7e91b855738 | 2026-01-06 | Warnings | M012 |
| Berkley and Jensen Tussin DM Max | DEXTROMETHORPHAN HBR, GUAIFENESIN | BJWC | c15b97a8-968f-4d38-905e-863e9fd16ce6 | 2026-01-06 | Warnings | M012 |
| Complete Allergy Medicine | DIPHENHYDRAMINE HCL | Salado Sales, Inc. | c0f5c8ca-b187-40bf-9245-6a29f1c32c97 | 2026-01-06 | Warnings | M012 |
| Allergy Multi-Symptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | Cardinal Health 110, LLC. DBA Leader | c5776b1e-9f72-4a6a-9961-8ac8e05b3249 | 2026-01-06 | 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 |