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 |
|---|---|---|---|---|---|---|
| Allergy Childrens Allergy | DIPHENHYDRAMINE HYDROCHLORIDE | Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) | 047102c4-3d03-4b2d-961d-0ac75980147b | 2026-05-06 | Warnings | M012 |
| GOOD SENSE COMBO PACK DAYTIME AND NIGHTTIME | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | L. Perrigo Company | d25f2649-4f8a-4339-8443-faa0b98bdd70 | 2026-05-06 | Warnings | M012 |
| Allergy Relief 4 Hour | CHLORPHENIRAMINE MALEATE | WinCo Foods, LLC | 27e911e1-6d22-4a50-8413-1809c8973cbd | 2026-05-06 | Warnings | M012 |
| ALKA SELTZER COLD Cold Cough Maximum Strength Fast Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 51173330-d537-fb9c-e063-6394a90ae342 | 2026-05-05 | Warnings | M012 |
| Equate daytime severe vaporice cold and flu nighttime severe vapor ice cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE | Wal-Mart Stores Inc | 08e74a8d-8e8d-4cda-9adc-ea2ff4068353 | 2026-05-05 | Warnings | M012 |
| GOODSENSE COMBO PACK DAYTIME AND NIGHTTIME | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL | L. Perrigo Company | e42f9e0d-f990-4c33-af43-75acf5d77638 | 2026-05-05 | Warnings | M012 |
| Rugby Mucus and Chest Congestion 541 | GUAIFENESIN | Rugby Laboratories | 76472912-b66f-4bb4-937a-4a589683a78c | 2026-05-04 | Warnings | M012 |
| Sinus Congestion and Pain Daytime Non-Drowsy | ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE | H E B | e9dd2d7b-0a19-4a42-b51e-b9914f02406e | 2026-05-04 | Warnings | M012 |
| Sanatos Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Pharmadel LLC | 3dd3ed85-0c0a-8390-e063-6294a90a668e | 2026-05-04 | Warnings | M012 |
| Good Sense Daytime non drowsy cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | L. Perrigo Company | 0122cd34-5817-4af5-a51a-8d176dee0a30 | 2026-05-04 | Warnings | M012 |
| COLD AND FLU RELIEF | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Safeway | d810a6a9-6112-4e9d-a396-36084b7e110e | 2026-05-04 | Warnings | M012 |
| Benadryl Allergy Ultratab | DIPHENHYDRAMINE HYDROCHLORIDE | Savings Distributors LLC | 8d59d121-62a8-c43b-e053-2a95a90a5847 | 2026-05-01 | Warnings | M012 |
| Tylenol Cold Plus Flu Severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Savings Distributors LLC | 8e87f8de-f83e-0f8d-e053-2a95a90a8d6a | 2026-05-01 | Warnings | M012 |
| Tylenol Sinus Severe | ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Savings Distributors LLC | 8eecb3f0-eb5e-e847-e053-2995a90a86bd | 2026-05-01 | Warnings | M012 |
| Sinus Pressure and Congestion Relief PE Maximum Strength | PHENYLEPHRINE HCL | Rite Aid Corporation | fccea3c5-42af-4939-82bc-d9409b75f91f | 2026-05-01 | Warnings | M012 |
| Night Time Cold and Flu original | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Harris Teeter, LLC | cfaf4b3d-fab4-424d-adbe-aaedca58912d | 2026-04-30 | Warnings | M012 |
| Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | Harris Teeter, LLC | 21e7d323-5b78-43aa-b0fc-34c2a864ab9a | 2026-04-30 | Warnings | M012 |
| daytime severe cold and flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | H E B | ec0b5f4b-b58c-445f-acf1-c7ce301bba64 | 2026-04-30 | Warnings | M012 |
| Mucus Relief DM Max Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN | Harris Teeter, LLC | 098428ae-e87d-4c29-8f02-1590530da58e | 2026-04-29 | Warnings | M012 |
| Panadol Cold and Flu Day | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | 341761b9-f0be-f816-e063-6394a90a5e63 | 2026-04-29 | 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 |