Cough and Chest Congestion Maximum Strength
- Product NDC
- 69676-0077
- 11-digit product format
- 696760077
- Labeler code
- 69676
- Product ID
- 69676-0077_3857582e-3b04-90e9-e063-6294a90ab3d9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorphan HBr, Guaifenesin
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Genexa Inc.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-02-12
- Substance
- GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE
- Active strength
- 400; 20 mg/20mL; mg/20mL
- 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
- Cough and Chest Congestion Maximum Strength
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| GUAIFENESIN | 400 mg/20mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/20mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 495W7451VQ | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| e920b700-30d3-3266-e053-2a95a90a0639 | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69676-0077-9 | 2024-02-12 | C162847 | 48780-1 | 1030e365-408c-111a-e063-dadaa90a10e2 | Cough and Chest Congestion Maximum Strength |
| 69676-0077-9 | 2024-01-30 | C162847 | 48780-1 | 1030e365-408c-111a-e063-dadaa90a10e2 | Cough and Chest Congestion Maximum Strength |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69676-0077-9 | Cough and Chest Congestion Maximum Strength | 177 mL in 1 BOTTLE, PLASTIC | SUSPENSION | 177 | 7 | |
| 69676-0077-9 | Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo pack | 177 mL in 1 BOTTLE, PLASTIC | SUSPENSION | 177 mL | 400 mg in 20mL | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69676-0077 | COUGH AND CHEST CONGESTION MAXIMUM STRENGTH (DEXTROMETHORPHAN HBR, GUAIFENESIN) SUSPENSION [GENEXA INC.] | 6 | Current NDC, Legacy NDC, 1 package rows | 20250212_e920b700-30d3-3266-e053-2a95a90a0639.zip |
| 69676-0077 | MAXIMUM STRENGTH COUGH AND CHEST CONGESTION AND NIGHTTIME SEVERE COLD AND FLU COMBO PACK (DEXTROMETHORPHAN HBR, GUAIFENESIN, ACETAMINOPHEN, DOXYLAMINE SUCCINATE) KIT [GENEXA INC.] | 1 | Current NDC, Legacy NDC | 20240905_18835205-a9e3-15c2-e063-6394a90a8107.zip |
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 |
|---|---|---|---|---|---|---|
| MUCINEX Rapid Clear Day Night and Clear and Cool Nasal | ACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, TRIPROLIDINE HYDROCHLORIDE, AND OXYMETAZOLINE HYDROCHLORIDE | Reckitt Benckiser LLC | 37dcb0ed-df56-1bec-e063-6394a90a695e | 2026-05-13 | Warnings | M012 |
| Mucinex Rapid Clear Pain, Headache, and Mucus Congestion and Sinus Max Clear and Cool | OXYMETAZOLINE HYDROCHLORIDE, ACETAMINOPHEN AND GUAIFENESIN | Reckitt Benckiser LLC | 373e0d75-8def-4b98-e063-6394a90a5e47 | 2026-05-13 | Warnings | M012 |
| MUCINEX SINUS-MAX SEVERE NASAL CONGESTION RELIEF CLEAR and COOL NASAL | OXYMETAZOLINE HYDROCHLORIDE | Reckitt Benckiser LLC | 5a397466-8721-4060-a178-5ebfd7069cc9 | 2026-05-13 | Warnings | M012 |
| Maximum Strength Mucinex Sinus-Max Pressure, Pain and Cough | ACETAMINOPHEN, GUAIFENESIN | Reckitt Benckiser LLC | 350764de-7801-b24e-e063-6394a90ab3c3 | 2026-05-13 | Warnings | M012 |
| Cepacol Extra Strength Sore Throat and Cough | BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | c0cc32db-90f0-4106-8538-89821083ece1 | 2026-05-13 | Warnings | M012 |
| Mucinex Cold and Flu | ACETAMINOPHEN, GUAIFENESIN | Reckitt Benckiser LLC | e8bc4131-f7b0-926a-e053-2995a90a40ac | 2026-05-13 | Warnings | M012 |
| Mucinex Cold, Flu, and Sore Throat | ACETAMINOPHEN, GUAIFENESIN | Reckitt Benckiser LLC | 37ded76a-ee8d-f22c-e063-6394a90a00c2 | 2026-05-13 | Warnings | M012 |
| Mucinex Night Time Severe Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | fdb5c937-c148-eb46-e053-6394a90a8bed | 2026-05-13 | Warnings | M012 |
| Mucinex Cough Chest Congestion | DEXTROMETHORPHAN HBR, GUAIFENESIN | Reckitt Benckiser LLC | e9c32d81-cd9b-4ff2-e053-2995a90aa499 | 2026-05-13 | Warnings | M012 |
| Mucinex Nightshift Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 316b5569-b66f-f30c-e063-6394a90ae147 | 2026-05-13 | Warnings | M012 |
| Mucinex Nightshift Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | d9467ca2-df75-4fa1-92b3-d2101eb54a77 | 2026-05-13 | Warnings | M012 |
| Mucinex Nightshift Severe Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 12420092-3ef6-464b-9106-2d56cd6ef200 | 2026-05-13 | Warnings | M012 |
| Mucinex Nightshift Sinus Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 09fdf96f-345f-43f2-9f0f-8303ac70849e | 2026-05-13 | Warnings | M012 |
| Mucinex Childrens Mighty Chews Night Time Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE | Reckitt Benckiser LLC | 2ce31244-9c6c-b7dd-e063-6394a90a31a8 | 2026-05-13 | Warnings | M012 |
| equate daytime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Wal-Mart Stores Inc | 2ac53cc7-000f-41fd-b799-4e6d6886fe62 | 2026-05-13 | Warnings | M012 |
| nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Publix Super Markets Inc | 2201d5c0-bd51-47a7-9775-916b18573623 | 2026-05-13 | Warnings | M012 |
| topcare nite time cold and flu relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Topco Associates LLC | f868e4a0-e9fb-4e6a-9984-29a218246241 | 2026-05-13 | Warnings | M012 |
| nitetime cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Meijer Distribution Inc | 582fa36b-6d0c-4ff3-80ab-6e0da4b209e4 | 2026-05-13 | Warnings | M012 |
| SudoGest | PSEUDOEPHEDRINE HYDROCHLORIDE | Major Pharmaceuticals | 78faa497-6743-b85b-e053-2a91aa0ae822 | 2026-05-12 | Warnings | M012 |
| Allergy Relief mini Softgels | DIPHENHYDRAMINE HCI 25 MG | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | df1c620b-ff59-4126-99a5-1d6750888f2b | 2026-05-12 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2692304 | {1 (acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral Suspension) / 1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Suspension) } Pack | GPCK | 18835205-a9e3-15c2-e063-6394a90a8107 | 2 |
| 2692304 | 1 daytime (dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Suspension) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral Suspension) Pack | PSN | 18835205-a9e3-15c2-e063-6394a90a8107 | 2 |
| 2692302 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral Suspension | PSN | 18835205-a9e3-15c2-e063-6394a90a8107 | 2 |
| 2692303 | dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 20 mL Oral Suspension | PSN | 18835205-a9e3-15c2-e063-6394a90a8107 | 2 |
| 2692302 | acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral Suspension | SCD | 18835205-a9e3-15c2-e063-6394a90a8107 | 2 |
| 2692303 | dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML Oral Suspension | SCD | 18835205-a9e3-15c2-e063-6394a90a8107 | 2 |
| 2692304 | 1 daytime (dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Suspension) / 1 nighttime (acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral Suspension) Pack | SY | 18835205-a9e3-15c2-e063-6394a90a8107 | 2 |
| 2692302 | acetaminophen 650 MG / dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral Suspension | SY | 18835205-a9e3-15c2-e063-6394a90a8107 | 2 |
| 2692302 | APAP 32.5 MG/ML / dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral Suspension | SY | 18835205-a9e3-15c2-e063-6394a90a8107 | 2 |
| 2692303 | dextromethorphan HBr 20 MG / guaifenesin 400 MG per 20 ML Oral Suspension | SY | 18835205-a9e3-15c2-e063-6394a90a8107 | 2 |
| 2692303 | dextromethorphan HBr 5 MG / guaifenesin 100 MG per 5 ML Oral Suspension | SY | 18835205-a9e3-15c2-e063-6394a90a8107 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69676-0077-9 | 69676007709 | 177 mL in 1 BOTTLE, PLASTIC (69676-0077-9) | 177 ml | 2024-02-12 | 0000-00-00 | No | No | Current |