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 |
|---|---|---|---|---|---|---|
| Dollar General | NASAL PHENYLEPHRINE HYDROCHLORIDE | DOLGENCORP, INC. (DOLLAR GENERAL & REXALL) | e8fd3f0e-a023-4423-8906-17ae02bc083b | 2026-09-03 | Warnings | M012 |
| Mucus Relief Congestion and Cough Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCI | TARGET Corporation | 1bf9a59e-cc37-4780-ba75-7138c546eb19 | 2026-09-02 | Warnings | M012 |
| Childrens Multi Symptom Fever and Cold | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | THE KROGER CO. | 3daf7620-eb57-43d5-ba88-938b7221e346 | 2026-09-02 | Warnings | M012 |
| PHENAGIL | PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE | Gil Pharmaceutical Corp | 69fd13a1-2b76-8574-e053-2a91aa0a27e7 | 2026-09-02 | Warnings | M012 |
| PHENAGIL | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL | Gil Pharmaceutical Corp. | a6880389-0dc1-43a7-a73b-77f77bafe51e | 2026-09-02 | Warnings | M012 |
| PHENAGIL | PHENYLEPHRINE HCL AND CHLORPHENIRAMINE MALEATE | Gil Pharmaceutical Corp | fa8510d8-d50a-4743-ba87-a12e9ab43125 | 2026-09-02 | Warnings | M012 |
| PHENAGIL | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL | Gil Pharmaceutical Corp | dfcf1231-8271-458d-b375-e328d6fd4e9b | 2026-09-02 | Warnings | M012 |
| Nighttime Cold and Flu Multi Symptom Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Shield Pharmaceuticals Corp | decafa3a-3734-4161-bab0-121945881846 | 2026-09-02 | Warnings | M012 |
| Kroger Maximum Strength Severe Congestion and Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN, AND PHENYLEPHRINE HCL | KROGER COMPANY | 1ff037ea-1a3b-430a-be31-2e240cc3b6f3 | 2026-09-02 | Warnings | M012 |
| KROGER Mucus Relief DM Maximum Strength | DEXTROMETHORPHAN HBR AND GUAIFENESIN | KROGER COMPANY | 79d24014-1af7-4d62-bcb8-5bea76a7d6ee | 2026-09-02 | Warnings | M012 |
| Kroger No Drip | ALLERGY SINUS | KROGER COMPANY | 4788bafb-8866-4a0a-b217-226513799c24 | 2026-09-02 | Warnings | M012 |
| Maximum Strength Cold Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | KROGER COMPANY | e1d27123-358f-4b0c-8e3b-33474750a0e6 | 2026-09-02 | Warnings | M012 |
| Maximum Strength Nighttime Cold and Flu | ACETAMINOPHEN , DIPHENHYDRAMINE HCL,PHENYLEPHRINE HCL | THE KROGER CO | 058b2021-8a61-40b0-8a2e-a784d2b847fb | 2026-09-02 | Warnings | M012 |
| KROGER Dye Free Childrens Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | KROGER COMPANY | 2bea22e9-34b6-4961-94bb-5600dd90e891 | 2026-09-02 | Warnings | M012 |
| KROGER No Drip Nasal Mist Severe Congestion | OXYMETAZOLINE HYDROCHLORIDE | KROGER COMPANY | 7256e048-ad69-4322-844d-872f05e6fc8a | 2026-09-02 | Warnings | M012 |
| Daytime Cold and Flu Relief | ACETAMINOHPEN, DEXTROMETHORPHAN HBR, GUAIFENESIN PHENYLEPHRINE HCL | The Kroger Co. | 494e69ef-dc9f-4e14-b856-5eaf0f541a03 | 2026-09-02 | Warnings | M012 |
| MAX Tussin Cough and Chest Congestion DM Sugar Free | DEXTROMETHORPHAN HBR, GUAIFENESIN | Akron Pharma Inc. | 5c4c8115-cec9-4f2c-9ea9-328535e97b07 | 2026-09-01 | Warnings | M012 |
| MAX ALLERGY KIDS | DIPHENHYDRAMINE HCL | Akron Pharma Inc. | 96c4ade8-67b1-41e5-8624-fb49090208af | 2026-09-01 | Warnings | M012 |
| MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH SUGAR FREE | HEXYLRESORCINOL AND MENTHOL | Reckitt Benckiser LLC | 4a938e15-a996-8538-e063-6294a90ad4ee | 2026-09-01 | Warnings | M012 |
| Allergy Relief | CHLORPHENIRAMINE MALEATE | WALMART INC. | 5e6623c3-6210-4c50-94d6-5554f36876d1 | 2026-08-31 | 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 |