Theraflu Flu Relief Max Strength
- Product NDC
- 0067-8204
- 11-digit product format
- 000678204
- Labeler code
- 0067
- Product ID
- 0067-8204_230cebe9-cd25-45a4-a561-0d7c147f9efe
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Haleon US Holdings LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-06-27
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
- Active strength
- 1000; 30 mg/30mL; mg/30mL
- Pharmacologic classes
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Theraflu Flu Relief Max Strength
- Brand name suffix
- Daytime
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 1000 mg/30mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 30 mg/30mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 362O9ITL9D, 9D2RTI9KYH |
| Rxcui | 1359455 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0067-8204-01 | Theraflu Flu Relief Max StrengthDaytime | 245.5 mL in 1 BOTTLE | SYRUP | 245.5 | 5 | |
| 0067-8204-01 | Theraflu Flu Relief Max StrengthDaytime Nighttime Value Pack | 245.5 mL in 1 BOTTLE | SYRUP | 245.5 mL | 30 mg in 30mL | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0067-8204 | THERAFLU FLU RELIEF MAX STRENGTH DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR) SYRUP [HALEON US HOLDINGS LLC] | 4 | Current NDC, 1 package rows | 20241219_0324195f-506d-4747-990e-ad44e2a117d9.zip |
| 0067-8204 | THERAFLU FLU RELIEF MAX STRENGTH DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) KIT [HALEON US HOLDINGS LLC] | 3 | Current NDC | 20240310_3618ccf0-1f30-42e0-bb50-bfa45cf2b583.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1359455 | acetaminophen 500 MG / dextromethorphan HBr 15 MG in 15 mL Oral Solution | PSN | 0324195f-506d-4747-990e-ad44e2a117d9 | 5 |
| 1359455 | acetaminophen 33.3 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Solution | SCD | 0324195f-506d-4747-990e-ad44e2a117d9 | 5 |
| 1359455 | acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG per 30 ML Oral Solution | SY | 0324195f-506d-4747-990e-ad44e2a117d9 | 5 |
| 1359455 | acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG per 15 ML Oral Solution | SY | 0324195f-506d-4747-990e-ad44e2a117d9 | 5 |
| 1359455 | APAP 33.3 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML Oral Solution | SY | 0324195f-506d-4747-990e-ad44e2a117d9 | 5 |
| 2604635 | {1 (acetaminophen 33.3 MG/ML / chlorpheniramine maleate 0.133 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Solution) / 1 (acetaminophen 33.3 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Solution) } Pack | GPCK | 3618ccf0-1f30-42e0-bb50-bfa45cf2b583 | 4 |
| 2604635 | 1 nighttime (acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG in 30 mL Oral Solution) / 1 daytime (acetaminophen 1000 MG / dextromethorphan HBr 30 MG in 30 mL Oral Solution) Pack | PSN | 3618ccf0-1f30-42e0-bb50-bfa45cf2b583 | 4 |
| 2604562 | acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG in 30 mL Oral Solution | PSN | 3618ccf0-1f30-42e0-bb50-bfa45cf2b583 | 4 |
| 1359455 | acetaminophen 500 MG / dextromethorphan HBr 15 MG in 15 mL Oral Solution | PSN | 3618ccf0-1f30-42e0-bb50-bfa45cf2b583 | 4 |
| 2604562 | acetaminophen 33.3 MG/ML / chlorpheniramine maleate 0.133 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Solution | SCD | 3618ccf0-1f30-42e0-bb50-bfa45cf2b583 | 4 |
| 1359455 | acetaminophen 33.3 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Solution | SCD | 3618ccf0-1f30-42e0-bb50-bfa45cf2b583 | 4 |
| 2604635 | 1 nighttime (acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG in 30 mL Oral Solution) / 1 daytime (acetaminophen 1000 MG / dextromethorphan HBr 30 MG in 30 mL Oral Solution) Pack | SY | 3618ccf0-1f30-42e0-bb50-bfa45cf2b583 | 4 |
| 2604635 | 1 nighttime (acetaminophen 33.3 MG/ML / chlorpheniramine maleate 0.133 MG/ML / dextromethorphan HBr 1 MG/ML Oral Solution) / 1 daytime (acetaminophen 33.3 MG/ML / dextromethorphan HBr 1 MG/ML Oral Solution) Pack | SY | 3618ccf0-1f30-42e0-bb50-bfa45cf2b583 | 4 |
| 2604562 | acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG per 30 mL Oral Solution | SY | 3618ccf0-1f30-42e0-bb50-bfa45cf2b583 | 4 |
| 1359455 | acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG per 30 ML Oral Solution | SY | 3618ccf0-1f30-42e0-bb50-bfa45cf2b583 | 4 |
| 1359455 | acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG per 15 ML Oral Solution | SY | 3618ccf0-1f30-42e0-bb50-bfa45cf2b583 | 4 |
| 2604562 | APAP 33.3 MG/ML / chlorpheniramine maleate 0.133 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Solution | SY | 3618ccf0-1f30-42e0-bb50-bfa45cf2b583 | 4 |
| 1359455 | APAP 33.3 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML Oral Solution | SY | 3618ccf0-1f30-42e0-bb50-bfa45cf2b583 | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0067-8204-01 | 00067820401 | 245.5 mL in 1 BOTTLE (0067-8204-01) | 245.5 ml | 2022-06-27 | No | No | Current |