DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN
- Product NDC
- 69729-040
- 11-digit product format
- 697290040
- Labeler code
- 69729
- Product ID
- 69729-040_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 |
|---|---|---|---|---|---|---|
| 69729-040-04 | 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 |
|---|---|---|---|---|---|---|
| Cold and Head Congestion Severe | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | TopCo Associates LLC | e07d880b-a12a-4e5e-94c0-bd36bcfe738c | 2024-12-03 | Warnings | M012 |
| Head Congestion plus Mucus PE | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | TOPCARE | bd0a3679-1f7c-4c41-e053-2995a90a8fcb | 2024-12-03 | Warnings | M012 |
| Head Congestion plus Flu Severe PE | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | TOPCO ASSOCIATES LLC | bd09e4f3-3211-8c08-e053-2a95a90a73f9 | 2024-12-03 | Warnings | M012 |
| Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | OPMX LLC | b373a3a8-68c4-0187-e053-2995a90aad62 | 2024-12-03 | Warnings | M012 |
| Mucus Relief Cold and Flu All In One | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | TOPCARE | a1b281ec-fd42-963c-e053-2a95a90a4b71 | 2024-12-03 | Warnings | M012 |
| Mucus Relief Cold Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | TOPCO ASSOCIATES LLC | b3366ad4-5ef4-eb70-e053-2995a90acf33 | 2024-12-03 | Warnings | M012 |
| Meijer Medicated Chest Rub, 3.53 oz. Lavender | MENTHOL, CAMPHOR, EUCALYPTUS OIL | Meijer Distribution | 22516f25-b8aa-7511-e063-6394a90a6125 | 2024-12-03 | Warnings | M012 |
| Tenalif Children | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | OPMX LLC | 05cd9513-1a42-e990-e063-6294a90a57df | 2024-12-03 | Warnings | M012 |
| Tenalif Multi Symptom Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | OPMX LLC | 05cd94e7-1808-3bb3-e063-6294a90a4140 | 2024-12-03 | Warnings | M012 |
| Nasal Decongestant PE and Pain Relief Plus Mucus Relief | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Winco Foods, LLC | 31531f90-8933-46ab-b722-cb63e7738639 | 2024-12-03 | Warnings | M012 |
| Mucus Relief Sinus Pressure Pain and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | WINCO FOODS, LLC | f45f3ab4-5e10-3004-e053-2a95a90a0cb4 | 2024-12-03 | Warnings | M012 |
| good sense allergy | DIPHENHYDRAMINE HCL | NuCare Pharmaceuticals, Inc. | 2861b801-e778-822d-e063-6394a90aa1a8 | 2024-12-03 | Warnings | M012 |
| Sinus plus Headache | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION INC | fe0cf681-f42c-430c-8429-f7ba4bc5a976 | 2024-12-02 | Warnings | M012 |
| Allergy Multisymptom | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION INC | 5a5aa2ee-51b7-4698-bb27-3fb9d01bbea5 | 2024-12-02 | Warnings | M012 |
| Mucus Relief Sinus Severe Congestion Relief | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Chain Drug Marketing Association | 0ea270b7-9c28-49fb-9615-c4afdbdbc8f1 | 2024-12-02 | Warnings | M012 |
| Head Congestion Mucus PE | ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION INC | 0955d856-cc4e-4ef2-8bc0-1a632a5b5f79 | 2024-12-02 | Warnings | M012 |
| Head Congestion Flu Severe PE | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION INC | 40c9c90d-6c9e-40d0-921d-1fd34eff90bb | 2024-12-02 | Warnings | M012 |
| Mucus Relief Sinus Pressure Pain and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | CHAIN DRUG MARKETING ASSOCIATION INC | 3d068d30-9a00-49d7-bbe9-d6b53c19e86d | 2024-12-02 | Warnings | M012 |
| Diphenhydramine | DIPHENHYDRAMINE HYDROCHLORIDE | AAA Pharmaceutical, Inc. | 76724432-ff3c-404f-ba1f-5af68e3ab8c4 | 2024-12-02 | Warnings | M012 |
| Sinus and Headache | ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE | AAA Pharmaceutical, Inc. | 73d4fc82-8508-44f8-83ca-9f32c5cd847b | 2024-12-02 | 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 |
|---|---|---|---|---|---|---|---|---|
| 69729-040-04 | 69729004004 | 118 mL in 1 BOTTLE (69729-040-04) | 118 ml | 2021-02-01 | 0000-00-00 | No | No | Current |