Theraflu ExpressMax
- Product NDC
- 0067-8129
- 11-digit product format
- 000678129
- Labeler code
- 0067
- Product ID
- 0067-8129_131827e6-0141-cf1d-e063-6294a90ae248
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Haleon US Holdings LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2015-07-15
- Substance
- ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 650; 25; 10 mg/30mL; mg/30mL; mg/30mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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 ExpressMax
- Brand name suffix
- Nighttime Severe Cold and Cough
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 650 mg/30mL |
| DIPHENHYDRAMINE HYDROCHLORIDE | 25 mg/30mL |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/30mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
| TC2D6JAD40 | Internal UNII lookup |
| 04JA59TNSJ | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1298348 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| f5a66541-1b15-4dfe-91e0-d8d5f8fdc7fb | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0067-8129-08 | Theraflu ExpressMaxNighttime Severe Cold and Cough | 245.5 mL in 1 BOTTLE | SYRUP | 245.5 | 7 | |
| 0067-8129-08 | Theraflu ExpressMaxDaytime Nighttime Value Pack | 245.5 mL in 1 BOTTLE | SYRUP | 245.5 mL | 650 mg in 30mL | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0067-8129-08 | ML - Milliliter | 0067-8129 | d2541d5a-5905-40e7-bf8a-81fdf97222a8 | 1 | 2016-03-04 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0067-8129 | THERAFLU EXPRESSMAX NIGHTTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) SYRUP [HALEON US HOLDINGS LLC] | 7 | Current NDC, Legacy NDC, 1 package rows | 20240308_f5a66541-1b15-4dfe-91e0-d8d5f8fdc7fb.zip |
| 0067-8129 | THERAFLU EXPRESSMAX DAYTIME NIGHTTIME VALUE PACK (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [HALEON US HOLDINGS LLC] | 5 | Current NDC, Legacy NDC | 20240411_9736ad4c-8c2e-421f-b023-f91b72d2828b.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.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1298348 | acetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution | PSN | f5a66541-1b15-4dfe-91e0-d8d5f8fdc7fb | 7 |
| 1298348 | acetaminophen 21.7 MG/ML / diphenhydramine hydrochloride 0.833 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | f5a66541-1b15-4dfe-91e0-d8d5f8fdc7fb | 7 |
| 1298348 | acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | f5a66541-1b15-4dfe-91e0-d8d5f8fdc7fb | 7 |
| 1298348 | acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | f5a66541-1b15-4dfe-91e0-d8d5f8fdc7fb | 7 |
| 1298348 | APAP 21.7 MG/ML / Diphenhydramine Hydrochloride 0.833 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution | SY | f5a66541-1b15-4dfe-91e0-d8d5f8fdc7fb | 7 |
| 1803669 | {1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) / 1 (acetaminophen 21.7 MG/ML / diphenhydramine hydrochloride 0.833 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution) } Pack | GPCK | 9736ad4c-8c2e-421f-b023-f91b72d2828b | 5 |
| 1803669 | 1 daytime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG in 30 mL Oral Solution) Pack | PSN | 9736ad4c-8c2e-421f-b023-f91b72d2828b | 5 |
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution | PSN | 9736ad4c-8c2e-421f-b023-f91b72d2828b | 5 |
| 1298348 | acetaminophen 325 MG / diphenhydrAMINE HCl 12.5 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution | PSN | 9736ad4c-8c2e-421f-b023-f91b72d2828b | 5 |
| 1113705 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | 9736ad4c-8c2e-421f-b023-f91b72d2828b | 5 |
| 1298348 | acetaminophen 21.7 MG/ML / diphenhydramine hydrochloride 0.833 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SCD | 9736ad4c-8c2e-421f-b023-f91b72d2828b | 5 |
| 1803669 | 1 daytime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution) Pack | SY | 9736ad4c-8c2e-421f-b023-f91b72d2828b | 5 |
| 1113705 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | 9736ad4c-8c2e-421f-b023-f91b72d2828b | 5 |
| 1298348 | acetaminophen 325 MG / diphenhydramine HCl 12.5 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution | SY | 9736ad4c-8c2e-421f-b023-f91b72d2828b | 5 |
| 1113705 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | 9736ad4c-8c2e-421f-b023-f91b72d2828b | 5 |
| 1298348 | acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution | SY | 9736ad4c-8c2e-421f-b023-f91b72d2828b | 5 |
| 1113705 | APAP 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution | SY | 9736ad4c-8c2e-421f-b023-f91b72d2828b | 5 |
| 1298348 | APAP 21.7 MG/ML / Diphenhydramine Hydrochloride 0.833 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution | SY | 9736ad4c-8c2e-421f-b023-f91b72d2828b | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0067-8129-08 | 00067812908 | 245.5 mL in 1 BOTTLE (0067-8129-08) | 245.5 ml | 2015-07-15 | 0000-00-00 | No | No | Current |