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 |
|---|---|---|---|---|---|---|
| Mucinex Fast-Max Severe Congestion and Cough | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN | Reckitt Benckiser LLC | 3270f369-7a40-186d-e063-6394a90a8526 | 2026-05-19 | Warnings | M012 |
| Mucinex Fast-Max Day Cold and Flu and Night Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | fe44d1ee-1e03-b74f-e053-6294a90a8bb4 | 2026-05-19 | Warnings | M012 |
| Mucinex Fast-Max Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | 31ac6883-ffcd-39de-e063-6294a90a52dd | 2026-05-19 | Warnings | M012 |
| MUCINEX DAY TIME PAIN, HEADACHE and MUCUS CONGESTION and MUCINEX NIGHT TIME HEADACHE, COUGH and FEVER Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 325b41e1-f8d2-02ee-e063-6394a90aafff | 2026-05-19 | Warnings | M012 |
| Mucinex Fast-Max Day Cold and Flu and Mucinex Nightshift Night Severe Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDE | Reckitt Benckiser LLC | 326f1fd3-73ab-e515-e063-6294a90ab222 | 2026-05-19 | Warnings | M012 |
| Mucinex Fast-Max Day Cold and Flu and Night Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 6c85df30-a601-4de6-9fd6-818265d799ff | 2026-05-19 | Warnings | M012 |
| Mucinex Fast-Max Cold, Flu and Sore Throat Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 7050b583-c09b-4457-9a9c-70c0923b62c0 | 2026-05-19 | Warnings | M012 |
| Mucinex Fast-Max Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 27312ee4-d1f4-4a95-9c45-91fa5a01f5ba | 2026-05-19 | Warnings | M012 |
| Mucinex Rapid Clear Daytime Pain, Headache, and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | 37de53a7-5546-3804-e063-6294a90a0fb5 | 2026-05-19 | Warnings | M012 |
| Mucinex Fast-Max Cold and Flu Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | 36b07e49-c72c-45e5-e063-6394a90a804a | 2026-05-19 | Warnings | M012 |
| Mucinex Sinus Max Clear and Cool Severe Congestion | OXYMETAZOLINE HCI | Reckitt Benckiser LLC | 2ee95e17-bd94-d717-e063-6294a90a2173 | 2026-05-19 | Warnings | M012 |
| Mucinex Sinus Max Sinus Pressure Severe Congestion | OXYMETAZOLINE HCI | Reckitt Benckiser LLC | 2eeafd83-230c-af92-e063-6294a90a984e | 2026-05-19 | Warnings | M012 |
| Mucinex Fast-Max Congestion and Headache Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | d7017328-f8af-4601-9232-dc1104feaa0a | 2026-05-19 | Warnings | M012 |
| Mucinex Rapid Clear Pain Headache and Cough | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Reckitt Benckiser LLC | 32375b12-75ed-d605-e063-6294a90ad004 | 2026-05-19 | Warnings | M012 |
| Mucinex Sinus-Max Pressure, Pain and Cough Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 07da45b5-d05e-41b1-b233-f7034d556a8d | 2026-05-19 | Warnings | M012 |
| Mucinex Sinus-Max Severe Congestion and Pain Maximum Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | ad4e0e4d-cc1f-4176-835f-3ba76564c634 | 2026-05-19 | Warnings | M012 |
| Childrens Mucinex Multi-Symptom Cold | DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE | Reckitt Benckiser LLC | 60daf6e2-ded8-44e6-bd8d-9d221384adde | 2026-05-19 | Warnings | M012 |
| Mucinex Childrens Mini Melts Cold and Flu | ACETAMINOPHEN AND GUAIFENESIN | Reckitt Benckiser LLC | 401fe0a0-ec97-5248-e063-6394a90af27f | 2026-05-19 | Warnings | M012 |
| Childrens Cough and Congestion, Childrens Cold and Cough Day, Night | DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN | WALMART INC. | 312ae879-1124-40a4-b2ba-3f3070840021 | 2026-05-19 | Warnings | M012 |
| GOOD SENSE DAYTIME | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | L. Perrigo Company | 2597e84c-18b4-41a9-8e6a-ff0c4c1f0612 | 2026-05-18 | 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 |