Theraflu Flu Relief Max Strength
- Product NDC
- 0067-8205
- 11-digit product format
- 000678205
- Labeler code
- 0067
- Product ID
- 0067-8205_446e5d67-95c9-e039-e063-6294a90a6cfa
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Chlorpheniramine maleate, 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; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
- Active strength
- 1000; 4; 30 mg/30mL; mg/30mL; mg/30mL
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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
- 2026-12-31
- 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
- Theraflu Flu Relief Max Strength
- Brand name suffix
- Nighttime
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 1000 mg/30mL |
| CHLORPHENIRAMINE MALEATE | 4 mg/30mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 30 mg/30mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| V1Q0O9OJ9Z | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2604562 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 780907b8-34ba-4ec8-bcdf-b2a31bd111df | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0067-8205-01 | Theraflu Flu Relief Max StrengthNighttime | 245.5 mL in 1 BOTTLE | SYRUP | 245.5 | 5 | |
| 0067-8205-01 | Theraflu Flu Relief Max StrengthDaytime Nighttime Value Pack | 245.5 mL in 1 BOTTLE | SYRUP | 245.5 mL | 30 mg in 30mL | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0067-8205-01 | ML - Milliliter | 0067-8205 | 4caa04a4-1310-43be-828c-7d6dca78e82a | 1 | 2025-12-16 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0067-8205 | THERAFLU FLU RELIEF MAX STRENGTH NIGHTTIME (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) SYRUP [HALEON US HOLDINGS LLC] | 4 | Current NDC, 1 package rows | 20250115_780907b8-34ba-4ec8-bcdf-b2a31bd111df.zip |
| 0067-8205 | 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 |
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 |
|---|---|---|---|---|---|---|
| Daytime and Nighttime Cherry Cold and Flu | DAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, PHENYLEPHRINE HCL NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATE | TARGET CORPORATION | 0bf911bf-eafe-fe46-e063-6294a90a3903 | 2024-07-03 | Warnings | M012 |
| Family Wellness Effervescent Cold Relief Orange | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Family Dollar Services, Inc. | 4e13511b-fbb5-2523-e054-00144ff88e88 | 2024-07-03 | Warnings | M012 |
| Nighttime Cherry Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE | TARGET CORPORATION | 1c3f6cbf-a00d-45b9-e063-6394a90a797c | 2024-07-02 | Warnings | M012 |
| Cold Terminator Cold Relief | PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Wildman Business Group | e8538d9c-f9ba-40b1-b60f-f57921f39b64 | 2024-07-01 | Warnings | M012 |
| Nighttime Severe Honey Cold and Flu | ACETAMINOPHEN, DEXTROMETHROPHAN, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | TARGET CORPORATION | 1c02e465-8750-a088-e063-6394a90a8efb | 2024-06-29 | Warnings | M012 |
| ACTIDOM DMX | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | ACTIPHARMA, LLC | 0166322e-7dbb-4658-a5c5-1d0525bb7655 | 2024-06-28 | Warnings | M012 |
| ACTINEL DM | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | ACTIPHARMA, LLC | 16660d82-524b-42ca-8581-48237caa13b2 | 2024-06-28 | Warnings | M012 |
| PurgenLabs Acetaminophen | ACTAMINOPHEN | Advanced Rx LLC | 915c4608-af1b-4119-8291-4ce9fd701d76 | 2024-06-28 | Warnings | M012 |
| Daytime Ultra Concentrated Cold and Flu | ACETAMINOPHEN, DEXTROMETHROPHAN HBR, PHENYLEPHRINE HCL | TARGET CORPORATION | 1bc90b2f-612c-e977-e063-6294a90a40b4 | 2024-06-26 | Warnings | M012 |
| Halls Mentholyptus | MENTHOL | Mondelez Global LLC | f5292c5b-5608-4e13-afc2-4f3d7133da88 | 2024-06-25 | Warnings | M012 |
| Halls Strawberry | MENTHOL | Mondelez Global LLC | 75638f29-7f2a-46b0-b8a0-e87bc7d6eba1 | 2024-06-25 | Warnings | M012 |
| Good Sense Nasal Decongestant PE | PHENYLEPHRINE HYDROCHLORIDE | A-S Medication Solutions | 5396a9cf-16eb-4628-9432-f49c67ffe2ce | 2024-06-25 | Warnings | M012 |
| Nighttime Cold and Flu Liquid | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | TARGET CORPORATION | 130ca5f1-2951-ec6f-e063-6394a90a754f | 2024-06-24 | Warnings | M012 |
| Daytime and Nighttime Severe Honey Cold and Flu | DAYTIME - ACETAMINOPHEN. DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL AND NIGHTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DOXYLAMINE SUCCINATE | TARGET CORPORATION | 08fd1513-30ab-15da-e063-6394a90ab57d | 2024-06-21 | Warnings | M012 |
| Daytime Severe and Nighttime Severe cold and flu | DAYTIME SEVERE - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, NIGHTTIME SEVERE-ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | TARGET CORPORATION | 0c0caa59-0637-bc33-e063-6294a90ae244 | 2024-06-21 | Warnings | M012 |
| Halls Strawberry | MENTHOL | Mondelez Global LLC | de401eb4-3282-4298-8a51-15d268253464 | 2024-06-21 | Warnings | M012 |
| Cough and Chest Congestion DM Maximum Strength | DEXTROMETHORPHAN HBR, GUAIFENESIN | Walgreens | e4515d0e-c12b-40cd-8218-6d91476cfebd | 2024-06-21 | Warnings | M012 |
| SUDOGEST | PSEUDOEPHEDRINE HCL | A-S Medication Solutions | 1811199f-bf88-475f-8f94-b372db4bead3 | 2024-06-20 | Warnings | M012 |
| Theraflu Severe Cold Relief Soft Chews | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | 91dbb541-6a86-4803-a1fe-1bf61b457c34 | 2024-06-19 | Warnings | M012 |
| Tukol Max Action Cold, Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Genomma Lab USA | aedce1f9-4902-4c51-92e0-6056196394c2 | 2024-06-14 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2604562 | acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG in 30 mL Oral Solution | PSN | 780907b8-34ba-4ec8-bcdf-b2a31bd111df | 5 |
| 2604562 | acetaminophen 33.3 MG/ML / chlorpheniramine maleate 0.133 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Solution | SCD | 780907b8-34ba-4ec8-bcdf-b2a31bd111df | 5 |
| 2604562 | acetaminophen 1000 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG per 30 mL Oral Solution | SY | 780907b8-34ba-4ec8-bcdf-b2a31bd111df | 5 |
| 2604562 | APAP 33.3 MG/ML / chlorpheniramine maleate 0.133 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Solution | SY | 780907b8-34ba-4ec8-bcdf-b2a31bd111df | 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 |
|---|---|---|---|---|---|---|---|
| 0067-8205-01 | 00067820501 | 245.5 mL in 1 BOTTLE (0067-8205-01) | 245.5 ml | 2022-06-27 | No | No | Current |