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 |
|---|---|---|---|---|---|---|
| CHILDRENS COLD AND COUGH | BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE | H E B | 08f4785a-c628-4e9b-9412-b2a817f9be60 | 2025-11-07 | Warnings | M012 |
| G-TUSICOF | DEXTROMETHORPHAN, GUAIFENESIN, AND PHENYLEPHRINE | Kramer Novis | d169585f-b4f4-4831-8c71-e1533ae7e7c4 | 2025-11-07 | Warnings | M012 |
| Cold and Flu Relief | ACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCL | QUALITY CHOICE (Chain Drug Marketing Association) | 1d512053-7a54-4691-a657-77da4c627cb8 | 2025-11-07 | Warnings | M012 |
| Allergy and Headache | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | dc249163-26dd-42ca-b423-2f16299f2d65 | 2025-11-07 | Warnings | M012 |
| Sinus Congestion | PSEUDOEPHEDRINE HCL | Chain Drug Marketing Association, Inc. | 9744d04d-298d-4acd-9470-db9e7f2901e7 | 2025-11-07 | Warnings | M012 |
| Daytime, Nighttime Severe Cold and Flu Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | c3b7fab1-f7fe-41be-a1c4-7ba4ba23c159 | 2025-11-07 | Warnings | M012 |
| Severe Cold and Flu Relief Daytime/Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL | ARMY AND AIR FORCE EXCHANGE SERVICE | 1c0c562a-68dc-4e9a-b8f3-ae70b9a4948e | 2025-11-07 | Warnings | M012 |
| Vicks DayQuil HIGH BLOOD PRESSURE COLD and FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | The Procter & Gamble Manufacturing Company | ff0bffee-9a36-8246-e053-6294a90a86c7 | 2025-11-06 | Warnings | M012 |
| Xlear Nasal Decongestant | NASAL SPRAY | Xlear Inc. | 1c1db71a-47d0-42ac-8cbe-95e76dca185f | 2025-11-06 | Warnings | M012 |
| Robitussin Honey Cough DM Day Night Value Pack | DEXTROMETHORPHAN HBR, GUAIFENESIN, DOXYLAMINE SUCCINATE | Haleon US Holdings LLC | 1bbd0157-06e6-4a3b-bac9-91ac879ba089 | 2025-11-06 | Warnings | M012 |
| ValuMeds Nasal Decongestant Phenylephrine HCl | PHENYLEPHRINE HYDROCHLORIDE | Cabinet Health P.B.C. | 21676b0c-6be2-464c-ae91-92e5f0d0087d | 2025-11-06 | Warnings | M012 |
| COLD AND FLU SEVERE Daytime, Nighttime | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | Meijer Distribution, Inc. | 04715af5-e861-496c-834a-233eb7312556 | 2025-11-06 | Warnings | M012 |
| Severe Allergy Plus Sinus Headache | ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL | Wal-Mart Stores Inc | 1a1f41c4-5430-4cff-873e-6547dadc8779 | 2025-11-06 | Warnings | M012 |
| Target Overnight Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCL | TARGET CORPORATION | 05e944d5-3473-4d8c-8df4-2ffc7474e9fa | 2025-11-05 | Warnings | M012 |
| Target Cough plus Chest Congestion DM Max with Honey | DEXTROMETHORPHAN HBR, GUAIFENESIN | TARGET CORPORATION | e36f179e-5aed-4fee-8b0a-767bf3590752 | 2025-11-05 | Warnings | M012 |
| Target Maximum Strength Cold Flu and Sore Throat | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL | TARGET CORPORATION | 1d3ad31f-ef4d-45ba-a6e3-13d66b51d1d2 | 2025-11-05 | Warnings | M012 |
| Up and Up maximum Strength fast mucus relief Severe Congestion and Cough | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Target Corporation | f007beaa-b108-46d5-8a98-853f011a8e2e | 2025-11-05 | Warnings | M012 |
| Target Childrens Cough Relief | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | TARGET CORPORATION | 975e157a-8f8d-41ad-b55b-9f9100188ccd | 2025-11-05 | Warnings | M012 |
| Target Maximum Strength Cold Flu and Sore Throat Overnight Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL AND TRIPROLIDINE HCL | TARGET CORPORATION | 6e94fdab-27ea-4c0f-a91c-735ce697304b | 2025-11-05 | Warnings | M012 |
| Target Dye Free Childrens Allergy Relief | DIPHENHYDRAMINE HYDROCHLORIDE | Target Corporation | 76299495-7259-4bbe-8393-7eabfe22715a | 2025-11-05 | 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 |