Theraflu Flu Relief Max Strength
- Product NDC
- 0067-8206
- 11-digit product format
- 000678206
- Labeler code
- 0067
- Product ID
- 0067-8206_4df42ed2-1eee-3fa9-e063-6394a90abd10
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, and Acetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr
- Dosage form
- KIT
- Labeler
- Haleon US Holdings LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-06-27
- 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
- Theraflu Flu Relief Max Strength
- Brand name suffix
- Daytime Nighttime Value Pack
- Listing expiration
- 2027-12-31
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3618ccf0-1f30-42e0-bb50-bfa45cf2b583 | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0067-8206-01 | 2026-01-29 | C162847 | 48780-1 | 49896155-ac82-586f-e063-e6dba90add90 | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 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 |
| 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 |
| 0067-8206-01 | Theraflu Flu Relief Max StrengthDaytime Nighttime Value Pack | 1 in 1 CARTON | KIT | 1 | 4 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0067-8206-01 | ML - Milliliter | 0067-8206 | aa53d259-b04a-4a2d-b256-f7a97bc3fce6 | 1 | 2026-04-20 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0067-8206 | 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, Legacy NDC, 3 package rows | 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 |
|---|---|---|---|---|---|---|
| QUALITY CHOICE | COUGH DROPS VITAMIN C | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 23086723-5718-6d02-e063-6394a90a03d2 | 2025-12-29 | Warnings | M012 |
| QUALITY CHOICE Cough Drops Creamy Strawberry | COUGH DROPS CREAMY STRAWBERRY | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 23085717-b2ee-175c-e063-6394a90a7f54 | 2025-12-29 | Warnings | M012 |
| QUALITY CHOICE | COUGH DROPS MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 2307bbe9-7c8f-4eff-e063-6394a90af4c3 | 2025-12-29 | Warnings | M012 |
| Premier Value | COUGH DROPS CHERRY | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 2a2de803-900d-02f4-e063-6394a90a84cc | 2025-12-29 | Warnings | M012 |
| QUALITY CHOICE | COUGH DROPS HONEY LEMON SUGAR FREE | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 2307f3a7-f6e7-8a5d-e063-6394a90ab7eb | 2025-12-29 | Warnings | M012 |
| Premier Value | COUGH DROPS MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 2a2e8fbe-c1c3-79b1-e063-6394a90a4d73 | 2025-12-29 | Warnings | M012 |
| Premier Value | COUGH DROPS HONEY LEMON | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 2a2dfcc3-e599-3102-e063-6394a90ad54a | 2025-12-29 | Warnings | M012 |
| Premier Value | COUGH DROPS BLACK CHERRY SUGAR FREE | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 2a2ead3c-b4d5-ee8f-e063-6294a90a3c39 | 2025-12-29 | Warnings | M012 |
| MGC Health | COUGH DROPS CREAMY STRAWBERRY | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 29f42644-045b-c4b3-e063-6294a90a48fd | 2025-12-29 | Warnings | M012 |
| MGC Health | COUGH DROPS VANILLA HONEY | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 29f45499-bf14-03e4-e063-6394a90a535c | 2025-12-29 | Warnings | M012 |
| MGC Health | COUGH DROPS BLACK CHERRY SUGAR FREE | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 29f3ddcc-9d4e-f1b1-e063-6294a90ac86f | 2025-12-29 | Warnings | M012 |
| Menthol Flavor Cough Drop | MENTHOL FLAVOR COUGH DROP | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 274a5551-4989-d8fe-e063-6394a90aeabf | 2025-12-29 | Warnings | M012 |
| MENTHOL COUGH SUPPRESSANT ORAL ANESTHETIC Cough Drops | MENTHOL | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 29f2acaa-2cc8-a999-e063-6294a90a15ce | 2025-12-29 | Warnings | M012 |
| Leader Throat Soothing Drops Creamy Strawberry | THROAT SOOTHING CREAMY STRAWBERRY | Xiamen Kang Zhongyuan Biotechnology Co., Ltd. | 26a92ecc-6a9c-b569-e063-6394a90a8bcb | 2025-12-29 | Warnings | M012 |
| ValuMeds Allergy Relief Antihistamine Diphenhydramine HCl | DIPHENHYDRAMINE HYDROCHLORIDE | Cabinet Health P.B.C. | a5ceab90-6885-4f3a-b001-97679e03c01b | 2025-12-29 | Warnings | M012 |
| Goodmeds Non-Drowsy Cough Relief | DEXTROMETHORPHAN HYDROBROMIDE | Cabinet Health P.B.C. | 32482083-3f51-41f4-8d20-bedf143e066d | 2025-12-29 | Warnings | M012 |
| Tusnel EX | GUAIFENESIN | Llorens Pharmaceutical International Division, Inc. | 77c16288-68c4-476c-995f-86f505663270 | 2025-12-29 | Warnings | M012 |
| Tusnel DM | DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Llorens Pharmaceutical International Division, Inc. | fe457e6d-422d-496c-bcb9-33594f3c42ff | 2025-12-29 | Warnings | M012 |
| Tusnel Diabetic | DEXTROMETHORPHAN, GUAIFENESIN | LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION | 66b3c094-809e-4d2c-bc15-46563de685cb | 2025-12-29 | Warnings | M012 |
| Fortify | MENTHOL | Natures Formulae Health Products Ltd. | 781d53cf-b3dc-3e2b-e053-2a91aa0a7dcd | 2025-12-29 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 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 | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0067-8204-01 | 00067820401 | 245.5 mL in 1 BOTTLE | 245.5 ml | Historical | ||||
| 0067-8205-01 | 00067820501 | 245.5 mL in 1 BOTTLE | 245.5 ml | Historical | ||||
| 0067-8206-01 | 00067820601 | 1 KIT in 1 CARTON (0067-8206-01) * 245.5 mL in 1 BOTTLE (0067-8204-01) * 245.5 mL in 1 BOTTLE (0067-8205-01) | 1 kit | 2022-06-27 | 0000-00-00 | No | No | Current |