THERAFLU
- Product NDC
- 0067-6426
- 11-digit product format
- 000676426
- Labeler code
- 0067
- Product ID
- 0067-6426_100acde5-899f-0bed-e063-6294a90aa1a9
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN, DEXTROMETHORPHAN HBr, PHENYLEPHRINE HCl
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- Haleon US Holdings LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2014-07-01
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 500; 20; 10 mg/237mL; mg/237mL; mg/237mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
- 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
- Brand name suffix
- MULTI-SYMPTOM SEVERE COLD
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 500 mg/237mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/237mL |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/237mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| 9D2RTI9KYH | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1189316 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| a4c56ca0-7785-404b-996d-137cc135f270 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e4e263da-1c53-440f-bb80-b7a575843b5a | Product name | 1 | 20260313 |
| d2168cac-a261-415a-9c78-3522859fa720 | Product name | 3 | 20251124 |
| 05a8cdd1-eeb8-409e-b938-0778225eca7d | Product name | 4 | 20250221 |
| e5b5c132-b15d-435b-9faa-2f74e5cadcf9 | Product name | 8 | 20250220 |
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| f489e8f3-5c9e-4818-b539-a73587edcfc7 | Product name | 2 | 20240229 |
| 0f7ae452-206d-4fc4-868d-56fc47074084 | Product name | 1 | 20231011 |
| b5abe2e3-39a1-43eb-9bff-f3c1653fe3df | Product name | 2 | 20190930 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 42f3c020-f1b3-89bc-7bdc-e1f10e680485 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0067-6426-01 | THERAFLUMULTI-SYMPTOM SEVERE COLD | 237 mL in 1 PACKET | POWDER, FOR SOLUTION | 237 | 11 | |
| 0067-6426-06 | THERAFLUMULTI-SYMPTOM SEVERE COLD | 6 in 1 CARTON | POWDER, FOR SOLUTION | 6 | 11 | |
| 0067-6426-01 | Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough | 237 mL in 1 PACKET | POWDER, FOR SOLUTION | 1422 mL | 500 mg in 237mL | 8 |
| 0067-6426-01 | Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough | 237 mL in 1 PACKET | POWDER, FOR SOLUTION | 4266 mL | 500 mg in 237mL | 8 |
| 0067-6426-06 | Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough | 6 in 1 CARTON | POWDER, FOR SOLUTION | 500 mg in 237mL | 8 | |
| 0067-6426-06 | Theraflu Multi-Symptom Severe Cold and Theraflu Nighttime Severe Cold and Cough | 6 in 1 CARTON | POWDER, FOR SOLUTION | 500 mg in 237mL | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0067-6426-01 | EA - Each | 0067-6426 | 58cccbc7-1d11-42e3-b3cb-081fe8fafced | 1 | 2020-09-14 |
| 0067-6426-06 | EA - Each | 0067-6426 | c8500b3f-3199-4fa6-8abd-9dd87445b1ac | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0067-6426 | THERAFLU MULTI-SYMPTOM SEVERE COLD (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [HALEON US HOLDINGS LLC] | 11 | Current NDC, Legacy NDC, 2 package rows | 20240129_a4c56ca0-7785-404b-996d-137cc135f270.zip |
| 0067-6426 | THERAFLU MULTI-SYMPTOM SEVERE COLD AND THERAFLU NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL) KIT [HALEON US HOLDINGS LLC] | 8 | Current NDC, Legacy NDC | 20240411_b06b64c5-dbb4-4ef5-af18-3d7d4979c02f.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 Plus Maximum Strength Cough, Mucus and Congestion Powermax | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | a6a2dd4a-a3c8-2dfa-e053-2995a90ada86 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Cold Sparkling Original PowerFast Fizz | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | bd49121c-7cba-c51f-e053-2995a90a921e | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Cough, Mucus and Congestion Day and Night | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare, LLC. | a6b8dc25-0fb9-1823-e053-2a95a90adf93 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night | ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | c2232241-6e57-1427-e053-2995a90a488a | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Cold and Cough Power Max Gels | ACETAMINOPHEN, CHLORPHENIRAMINE MALAEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 51dec468-fbb2-3489-e054-00144ff88e88 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cold PowerFast Fizz Day and Night | ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | d7711cd6-5058-548d-e053-2a95a90ac54d | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz | CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE | Bayer HealthCare LLC. | a2f0285b-8550-fd26-e053-2995a90ab615 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Cold Day and Night PowerMax gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | f6c73f61-f4fc-377f-e053-6294a90a3797 | 2025-12-04 | Warnings | M012 |
| Alka Seltzer Plus Maximum Strength Cough Chest Congestion PowerFast Fizz | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Bayer Healthcare LLC. | a32e2a5e-9aa0-4e7c-e053-2995a90a3190 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Cold Day and Night PowerMax gels | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | e2877488-3539-cba2-e053-2995a90a6005 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Cough and Sore Throat FizzyChews | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Bayer HealthCare LLC. | 14951faa-9476-6f29-e063-6394a90a14c7 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cough Mucus and Congestion Liquid Gels | ALKA-SELTZER PLUS SEVERE COUGH MUCUS AND CONGESTION | Bayer HealthCare LLC. | 0c120569-622d-3a23-e054-00144ff88e88 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Cold and Flu FizzyChews | CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Bayer HealthCare LLC. | 149330be-24bd-b4a4-e063-6394a90a9007 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Severe Cough Mucus and Congestion Day and Night | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE, GUAIFENESIN | Bayer HealthCare LLC. | 5278a128-41ec-4494-e054-00144ff8d46c | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Cold Orange Zest | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | 53188c41-3f13-311b-e054-00144ff88e88 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Cold Day and Night | ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATE | Bayer HealthCare LLC. | 75894849-a0ba-57be-e053-2a91aa0a049a | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Cold Sparkling Original | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | 531ab703-179a-70ad-e054-00144ff88e88 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Cold Night | ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | 7588ea67-68a9-4dc0-e053-2991aa0aa471 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Cold and Cough | ASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE | Bayer HealthCare LLC. | 75862805-2cfe-fb45-e053-2991aa0a1403 | 2025-12-04 | Warnings | M012 |
| Alka-Seltzer Plus Maximum Strength Day Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Bayer HealthCare LLC. | 5172dc01-4e7f-3307-e054-00144ff8d46c | 2025-12-04 | Warnings | M012 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1189316 | acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral Solution | PSN | a4c56ca0-7785-404b-996d-137cc135f270 | 11 |
| 1189316 | acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution | SCD | a4c56ca0-7785-404b-996d-137cc135f270 | 11 |
| 1189316 | acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Packet for Oral Solution | SY | a4c56ca0-7785-404b-996d-137cc135f270 | 11 |
| 1189316 | acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution | SY | a4c56ca0-7785-404b-996d-137cc135f270 | 11 |
| 1189316 | APAP 500 MG / Dextromethorphan Hydrobromide 20 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral Solution | SY | a4c56ca0-7785-404b-996d-137cc135f270 | 11 |
| 2640034 | {1 (acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution) / 1 (acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution) } Pack | GPCK | b06b64c5-dbb4-4ef5-af18-3d7d4979c02f | 8 |
| 2640034 | 1 daytime (acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Granules for Oral Solution) Pack | PSN | b06b64c5-dbb4-4ef5-af18-3d7d4979c02f | 8 |
| 1189316 | acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral Solution | PSN | b06b64c5-dbb4-4ef5-af18-3d7d4979c02f | 8 |
| 1659960 | acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Granules for Oral Solution | PSN | b06b64c5-dbb4-4ef5-af18-3d7d4979c02f | 8 |
| 1189316 | acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution | SCD | b06b64c5-dbb4-4ef5-af18-3d7d4979c02f | 8 |
| 1659960 | acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution | SCD | b06b64c5-dbb4-4ef5-af18-3d7d4979c02f | 8 |
| 2640034 | 1 daytime (acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Granules for Oral Solution) Pack | SY | b06b64c5-dbb4-4ef5-af18-3d7d4979c02f | 8 |
| 1189316 | acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Packet for Oral Solution | SY | b06b64c5-dbb4-4ef5-af18-3d7d4979c02f | 8 |
| 1189316 | acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution | SY | b06b64c5-dbb4-4ef5-af18-3d7d4979c02f | 8 |
| 1659960 | acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Packet for Oral Solution | SY | b06b64c5-dbb4-4ef5-af18-3d7d4979c02f | 8 |
| 1659960 | acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution | SY | b06b64c5-dbb4-4ef5-af18-3d7d4979c02f | 8 |
| 1189316 | APAP 500 MG / Dextromethorphan Hydrobromide 20 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral Solution | SY | b06b64c5-dbb4-4ef5-af18-3d7d4979c02f | 8 |
| 1659960 | APAP 650 MG / Diphenhydramine Hydrochloride 25 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral Solution | SY | b06b64c5-dbb4-4ef5-af18-3d7d4979c02f | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0067-6426-01 | 00067642601 | 237 mL in 1 PACKET | 237 ml | Historical | ||||
| 0067-6426-06 | 00067642606 | 6 PACKET in 1 CARTON (0067-6426-06) / 237 mL in 1 PACKET (0067-6426-01) | 6 packet | 2014-07-01 | 0000-00-00 | No | No | Current |