Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo pack
- Product NDC
- 69676-0079
- 11-digit product format
- 696760079
- Labeler code
- 69676
- Product ID
- 69676-0079_38f8afad-542e-ae0c-e063-6294a90a243f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorphan HBr, Guaifenesin, Acetaminophen, Doxylamine Succinate
- Dosage form
- KIT
- Labeler
- Genexa Inc.
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-05-31
- 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
- Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo pack
- Listing expiration
- 2027-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 18835205-a9e3-15c2-e063-6394a90a8107 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 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 |
| 69676-0079-3 | Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo pack | 2 in 1 KIT | KIT | 2 | 2 | |
| 69676-0079-3 | Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo pack | 1 in 1 BOTTLE | KIT | 1 | 2 | |
| 69676-0094-9 | Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo pack | 177 mL in 1 BOTTLE | SUSPENSION | 177 mL | 650 mg in 20mL | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 69676-0079 | 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, 4 package rows | 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 |
|---|---|---|---|---|---|---|
| Pain Relief Extra Strength | ACETAMINOPHEN | Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. | 5c42dd28-820c-4cc5-9016-11ad5e580616 | 2024-11-25 | Warnings | M013 |
| equate pain reliever | ACETAMINOPHEN | WALMART INC. | 4518fe82-3ba8-4e9e-a036-776df7fb8d57 | 2024-11-21 | Warnings | M013 |
| Family Wellness Pain Reliever | ASPIRIN | FAMILY WELLNESS SERVICES, INC. | 075e19f4-1a58-aedd-e063-6294a90af708 | 2024-11-20 | Warnings | M013 |
| Mejoralito | ACETAMINOPHEN | OPMX Chula Vista | fd2ecde0-296e-060f-e053-6294a90afd98 | 2024-11-15 | Warnings | M013 |
| Temp X | ACETAMINOPHEN | OPMX Chula Vista | fd2edc32-0351-c991-e053-6294a90ab4ce | 2024-11-15 | Warnings | M013 |
| CVS Health Extra Strength Antacid and Pain Reliever | ASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATE | CVS Pharmacy | afe9e755-18ba-305f-e053-2995a90aa8d0 | 2024-11-14 | Warnings | M013 |
| Walgreens Effervescent Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Walgreens | 667418fc-a3ab-cbc7-e053-2a91aa0a2023 | 2024-11-13 | Warnings | M013 |
| Up and Up Antacid and Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Target Corporation | a72eef45-b985-638a-e053-2995a90aa20a | 2024-11-13 | Warnings | M013 |
| Signature Care Effervescent Antacid and Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Safeway, Inc | 6e120024-475a-73af-e053-2a91aa0a42a6 | 2024-11-13 | Warnings, Adverse reactions | M013 |
| Kroger Effervescent Antacid and Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Kroger Company | 6d858b0e-a3c8-2686-e053-2991aa0acc06 | 2024-11-13 | Warnings | M013 |
| TopCare Effervescent Antacid and Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Topco Associates LLC | 639f9d57-f26a-708a-e053-2a91aa0a6962 | 2024-11-13 | Warnings, Adverse reactions | M013 |
| Effervescent Antacid and Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | H. E. Butt Grocery Company | 6418cde9-607b-4ca1-e053-2991aa0a9170 | 2024-11-13 | Warnings | M013 |
| Bromo Seltzer | ASPIRIN, SODIUM BICARBONATE, CITRIC ACID | Tower Laboratories Ltd | 8ff88ee1-e33e-4051-992f-24e2720c48ce | 2024-11-13 | Warnings | M013 |
| Care One Original Antacid and Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Foodhold U.S.A. | 8f662c51-d2fa-6458-e053-2995a90ac6fd | 2024-11-13 | Warnings | M013 |
| Top Value Effervescent Pain Relief | APIRIN, CITRIC ACID, SODIUM BICARBONATE | Tower Laboratories Ltd | 43c7f435-735c-3fab-e054-00144ff88e88 | 2024-11-13 | Warnings, Adverse reactions | M013 |
| DG Health Effervescent Antacid and Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | DOLGENCORP, INC | 8f1343d5-2884-3a14-e053-2a95a90a2f90 | 2024-11-13 | Warnings | M013 |
| Good Sense Effervescent Antacid and Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Good Sense | cd25b0c3-0134-beef-e053-2a95a90a092b | 2024-11-13 | Warnings | M013 |
| Drug Mart Effervescent Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Discount Drug Mart, Inc | 8bc65603-1dbf-30ab-e053-2995a90a7c15 | 2024-11-13 | Warnings | M013 |
| Best Choice Effervescent Antacid Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Valu Merchandisers Company | 8aab905b-5fe7-dddb-e053-2995a90a6c6f | 2024-11-13 | Warnings | M013 |
| Publix Fast Relief Effervescent | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Publix Super Markets Inc. | 73051f16-2569-7394-e053-2991aa0a5359 | 2024-11-13 | Warnings | M013 |
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 | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 69676-0077-9 | 69676007709 | 177 mL in 1 BOTTLE, PLASTIC | 177 ml | Historical | |||
| 69676-0079-3 | 69676007903 | 2 BOTTLE in 1 KIT (69676-0079-3) / 1 KIT in 1 BOTTLE * 177 mL in 1 BOTTLE, PLASTIC (69676-0077-9) * 177 mL in 1 BOTTLE (69676-0094-9) | 2 bottle | 2024-05-31 | No | No | Current |
| 69676-0094-9 | 69676009409 | 177 mL in 1 BOTTLE | 177 ml | Historical |