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 |
|---|---|---|---|---|---|---|
| ALKA SELTZER COLD Cold and Flu Severe Day Night Fast Dissolve | ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | 50762d7c-5efd-4f83-e063-6294a90abf7f | 2026-04-27 | Warnings | M012 |
| Cold and Flu Nighttime Relief | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | L.N.K. International, Inc. | 6427b418-89d1-4eac-b25b-0adfefc204fc | 2026-04-27 | Warnings | M012 |
| Nighttime Sleep Aid | DIPHENHYDRAMINE HCL | Care One (American Sales Company) | bd5de3b3-7cb5-4403-b664-23ac70b9957f | 2026-04-27 | Warnings | M012 |
| Leader Daytime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL | Cardinal Health 110, LLC. dba Leader | 333c7042-95b8-4d98-9df1-4287017afa36 | 2026-04-25 | Warnings | M012 |
| foster and thrive nasal | OXYMETAZOLINE HYDROCHLORIDE | Sportpharm LLC | f2d55d1b-c3d4-4c35-b761-681ed50273bd | 2026-04-24 | Warnings | M012 |
| Geri-Dryl allergy relief | DIPHENHYDRAMINE HCL | Sportpharm LLC | 2c4e0d5e-958d-4274-876a-52126c795c0f | 2026-04-24 | Warnings | M012 |
| ALKA SELTZER COLD Cold and Headache Maximum Strength Fast Dissolve | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | 50364a42-3333-51fe-e063-6394a90ab71e | 2026-04-24 | Warnings | M012 |
| ALKA SELTZER COLD Cold Flu Severe Fast Dissolve | CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Bayer HealthCare LLC. | 5036dc50-e95b-ea8d-e063-6394a90a6cfe | 2026-04-24 | Warnings | M012 |
| Cold and Flu Daytime Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED | dcb33d5f-87fa-4043-9b6d-36adec96796c | 2026-04-24 | Warnings | M012 |
| Diphenhydramine HCl | DIPHENHYDRAMINE HCL | Cardinal Health 107, LLC | abc0e348-8532-4658-bd8c-d7dbe5a28c7d | 2026-04-23 | Warnings | M012 |
| nitetime severe | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Publix Super Markets Inc | c5535aaf-c029-48d8-97d1-105a49b5fd95 | 2026-04-23 | Warnings | M012 |
| ALKA SELTZER COLD Cold and Cough Maximum Strength Fast Dissolve | ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Bayer Healthcare LLC. | 50228b3c-d54a-485d-e063-6394a90a4403 | 2026-04-23 | Warnings | M012 |
| ALKA SELTZER COLD Cold and Flu Severe Fast Chewables | CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Bayer HealthCare LLC. | 5025a333-6378-bf59-e063-6394a90af4f0 | 2026-04-23 | Warnings | M012 |
| POLY-HIST DM | DEXCHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HBR | POLY PHARMACEUTICALS, INC. | 5025c99f-b946-e2e0-e063-6394a90a13fb | 2026-04-23 | Warnings | M012 |
| ALKA SELTZER COLD Cold and Allergy Maximum Strength Fast Gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 5026611c-93e7-8f90-e063-6394a90a7baa | 2026-04-23 | Warnings | M012 |
| Allergy Relief | DIPHENHYDRAMINE HCL | DOLGENCORP, LLC | c9c1db0f-6ba4-433c-b0ce-e99e9351c0b0 | 2026-04-23 | Warnings | M012 |
| Severe Cold and Flu Plus Congestion | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCL | COSTCO WHOLESALE CORPORATION | 5180abbc-c6c4-4b82-b6e7-4504e3bcff0f | 2026-04-23 | Warnings | M012 |
| Severe Cold and Flu Night time | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | HyVee Inc | 4f963491-e1f0-494d-acb6-5f4d2b267d4a | 2026-04-22 | Warnings | M012 |
| Vicks Sinex SEVERE MOISTURIZING ULTRA FINE MIST | OXYMETAZOLINE HYDROCHLORIDE | Procter & Gamble Manufacturing GmbH | f4b01827-7444-3bfc-e053-2a95a90aebed | 2026-04-22 | Warnings | M012 |
| Vicks Sinex SEVERE ORIGINAL ULTRA FINE MIST | OXYMETAZOLINE HYDROCHLORIDE | Procter & Gamble Manufacturing GmbH, | cfd43b8f-8064-6b88-e053-2a95a90a329e | 2026-04-22 | 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 |