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 |
|---|---|---|---|---|---|---|
| tussin severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | H E B | 7cc2c136-d1b7-4658-99bb-73bb1d140261 | 2024-11-04 | Warnings | M012 |
| dg health tussin | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Dolgencorp Inc | a5d0ee70-d528-4a53-bf01-7bb13b364ed0 | 2024-11-04 | Warnings | M012 |
| basic care tussin cf severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Amazon.com Services LLC | bba9a17d-eb87-46f3-acee-c9dd34e5bfd4 | 2024-11-04 | Warnings | M012 |
| topcare tussin cf max | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Topco Associates LLC | b553b7e6-933b-49e3-97d3-22a4643a04b9 | 2024-11-04 | Warnings | M012 |
| dg health nasal original | OXYMETAZOLINE HYDROCHLORIDE | Dolgencorp, LLC | fb209752-705a-4bb0-9298-8b70357f3911 | 2024-11-02 | Warnings | M012 |
| nasal | OXYMETAZOLINE HYDROCHLORIDE | H E B | 3c301993-642a-487c-96a2-ebc4ef90dc88 | 2024-11-02 | Warnings | M012 |
| basic care nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Amazon.com Services LLC | 1341744c-43c3-462b-b93c-1e46476fd935 | 2024-11-01 | Warnings | M012 |
| Nighttime Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | CVS Pharmacy | 43784616-1afd-4ff7-8fee-6ac389f616a2 | 2024-11-01 | Warnings | M012 |
| topcare nite time cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Topco Associates LLC | 28ef87e8-29e5-444d-b1f7-5c38a7f758d3 | 2024-11-01 | Warnings | M012 |
| Good Sense Severe NightTime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | L. Perrigo Company | 0e3c36c9-d45b-41b9-891d-a42d854295f9 | 2024-11-01 | Warnings | M012 |
| severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Walgreen Company | 7dc3941a-e5f8-4caa-bae5-6a0d075295cb | 2024-11-01 | Warnings | M012 |
| DoloMax Cold Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | BENARD INDUSTRIES INC | 520aee75-8b9a-4dcc-8970-75e122640e91 | 2024-10-31 | Warnings | M012 |
| Good Sense Nasal | OXYMETAZOLINE HYDROCHLORIDE | A-S Medication Solutions | b6fbc0ba-7e88-4ab9-b0fa-1e1e8f9132fe | 2024-10-31 | Warnings | M012 |
| CareOne Nighttime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | American Sales Company | 819d5c82-0240-4013-9904-c335bd65d03e | 2024-10-30 | Warnings | M012 |
| Signature Care Nighttime Severe Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Safeway | 9a0ad5d5-8fd9-468d-be2c-87c14d08b934 | 2024-10-30 | Warnings | M012 |
| Good Sense Severe NightTime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | L. Perrigo Company | f2b77bc3-ba1e-4c3f-bbbd-fa93b2c37dd2 | 2024-10-30 | Warnings | M012 |
| dg health cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Dolgencorp, LLC | 81f3ac36-9bae-4f42-92a0-8a2e4bbd0984 | 2024-10-30 | Warnings | M012 |
| severe cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Rite Aid Corporation | 9a71e8eb-4195-4694-bf3e-44f691ff2cef | 2024-10-30 | Warnings | M012 |
| nighttime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | H E B | fe4a95d2-6fb3-43fe-baec-6f22d1965323 | 2024-10-30 | Warnings | M012 |
| NightTime Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Kroger Company | 2c9ef0d7-3d5b-494a-8f06-9dd42110d78a | 2024-10-30 | 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 |