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 |
|---|---|---|---|---|---|---|
| Allergy Relief | DIPHENHYDRAMINE HCL | WinCo Foods, LLC | 2cbf27b6-217c-46d8-89c9-e46f3668f002 | 2026-07-17 | Warnings | M012 |
| Best Choice | OXYMETAZOLINE HYDROCHLORIDE | BEST CHOICE (VALU MERCHANDISERS COMPANY) | d86d53cd-75ce-4c40-83cb-ada9b77a76f6 | 2026-07-17 | Warnings | M012 |
| LEADER Multi Symptom Flu Relief Daytime Max Strength | ACETAMINOPHEN, DEXTROMETHORPHAN HBR | CARDINAL HEALTH 110, LLC. DBA LEADER | 2212cf9e-6944-4922-b5b5-1373cf10b2e1 | 2026-07-16 | Warnings | M012 |
| Cold and Flu HBP | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE | CVS PHARMACY | 06756130-1608-4ae6-9772-95a4549853a1 | 2026-07-16 | Warnings | M012 |
| Medicated Chest Rub | CAMPHOR, EUCALYPTUS OIL, MENTHOL | Old East Main Co. | 7855033e-6a12-4cd8-b0a2-c5d69018d117 | 2026-07-16 | Warnings, Adverse reactions | M012 |
| Oxymetazoline Hydrochloride 12-Hour | OXYMETAZOLINE HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | 34a79f8b-32b7-48db-a895-c942cc795292 | 2026-07-16 | Warnings | M012 |
| LoHist D | CHLORPHENIRAMINE MALEATE / PSEUDOEPHEDRINE HCL | Larken Laboratories, Inc. | 93c9ad4f-3376-48c2-8276-0375663acd01 | 2026-07-16 | Warnings | M012 |
| Sanatos | MENTHOL | Pharmadel LLC | 522e1e7f-98ed-c475-e063-6294a90a622c | 2026-07-16 | Warnings | M012 |
| LEADER MS Flu Relief Nighttime | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND DEXTROMETHOPHAN HBR | CARDINAL HEALTH 110, LLC. DBA LEADER | 9db7d4e2-f7c1-41a7-8e1c-ef8d3512259d | 2026-07-16 | Warnings | M012 |
| NIGHTTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Amazon.com Services LLC | 1bf4cd96-5800-434d-a0dc-e84c759ebb33 | 2026-07-16 | Warnings | M012 |
| Mucus Relief Cough Childrens | DEXTROMETHORPHAN HBR, GUAIFENSIN | Walgreens | 2ace231a-94c4-479d-bb26-454bd07b207b | 2026-07-16 | Warnings | M012 |
| LEADER No Drip | ALLERGY SINUS NASAL MIST | CARDINAL HEALTH 110, LLC. DBA LEADER | e7b2c1c1-6250-4af3-b131-22aced2b23d5 | 2026-07-16 | Warnings | M012 |
| Mucus Relief DM Cough | DEXTROMETHORPHAN HBR, GUAIFENESIN | Amerisource Bergen | 639a59b7-ccff-485e-a232-38b680827229 | 2026-07-16 | Warnings | M012 |
| Equate Nighttime Vapor Ice Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE | WALMART INC. | 30470a01-4d42-44c6-a017-d68bb74cdef7 | 2026-07-15 | Warnings | M012 |
| Quality Choice Effervescent Cold Relief - Plus | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Chain Drug Marketing Association | 1f93fe6d-ee21-e323-e063-6394a90a61bf | 2026-07-15 | Warnings | M012 |
| Pentrexcilina Daytime | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL | OPMX LLC | b7b3c15a-bb28-5c25-e053-2a95a90ad3b1 | 2026-07-15 | Warnings | M012 |
| Quality Choice Effervescent Cold Relief - Orange | ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE | Chain Drug Marketing Association | 1f93c815-63c7-bfe0-e063-6394a90ab4a5 | 2026-07-15 | Warnings | M012 |
| Nighttime Severe Cold and Flu Maximum Strength mini softgels | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Shield Pharmaceuticals Corp | 5fa848ef-35ee-4e05-8ff2-781d034cf6ac | 2026-07-14 | Warnings | M012 |
| Cough and Cold HBP | CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Cardinal Health 110, LLC. DBA Leader | 0fad61d8-4393-47ec-9ff6-7df5be761f5b | 2026-07-14 | Warnings | M012 |
| Sinus and Allergy Relief PE | CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCL | Rite Aid Corporation | 211c4273-3b2c-4169-b9c6-7a87903e77cd | 2026-07-13 | 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 |