Theraflu
- Product NDC
- 0067-6803
- 11-digit product format
- 000676803
- Labeler code
- 0067
- Product ID
- 0067-6803_10682cca-1329-1e41-e063-6394a90a7e21
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN, DIPHENHYDRAMINE HCl, PHENYLEPHRINE HCl
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- Haleon US Holdings LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-01-20
- Substance
- ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 650; 25; 10 mg/237mL; mg/237mL; mg/237mL
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Theraflu
- Brand name suffix
- Severe Cold Relief Nighttime
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 650 mg/237mL |
| DIPHENHYDRAMINE HYDROCHLORIDE | 25 mg/237mL |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/237mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 362O9ITL9D, TC2D6JAD40, 04JA59TNSJ |
| Rxcui | 1659960 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0067-6803-02 | Theraflu Severe Cold Relief Daytime and Theraflu Severe Cold Relief Nighttime | 6 in 1 CARTON | POWDER, FOR SOLUTION | 25 mg in 237mL | 2 | |
| 0067-6803-02 | Theraflu Severe Cold Relief Daytime and Theraflu Severe Cold Relief Nighttime | 237 mL in 1 PACKET | POWDER, FOR SOLUTION | 1422 mL | 25 mg in 237mL | 2 |
| 0067-6803-02 | TherafluSevere Cold Relief Nighttime | 237 mL in 1 PACKET | POWDER, FOR SOLUTION | 237 | 1 | |
| 0067-6803-02 | TherafluSevere Cold Relief Nighttime | 6 in 1 CARTON | POWDER, FOR SOLUTION | 6 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0067-6803 | THERAFLU SEVERE COLD RELIEF DAYTIME AND THERAFLU SEVERE COLD RELIEF NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCL) KIT [HALEON US HOLDINGS LLC] | 2 | Current NDC | 20240201_e5ef7b85-feee-44a7-bd0e-ed91352c7434.zip |
| 0067-6803 | THERAFLU SEVERE COLD RELIEF NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [HALEON US HOLDINGS LLC] | 1 | Current NDC, 2 package rows | 20240203_4daca846-8511-4303-9e6c-9469f7f260ba.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 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 | e5ef7b85-feee-44a7-bd0e-ed91352c7434 | 2 |
| 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 | e5ef7b85-feee-44a7-bd0e-ed91352c7434 | 2 |
| 1189316 | acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral Solution | PSN | e5ef7b85-feee-44a7-bd0e-ed91352c7434 | 2 |
| 1659960 | acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Granules for Oral Solution | PSN | e5ef7b85-feee-44a7-bd0e-ed91352c7434 | 2 |
| 1189316 | acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution | SCD | e5ef7b85-feee-44a7-bd0e-ed91352c7434 | 2 |
| 1659960 | acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution | SCD | e5ef7b85-feee-44a7-bd0e-ed91352c7434 | 2 |
| 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 | e5ef7b85-feee-44a7-bd0e-ed91352c7434 | 2 |
| 1189316 | acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Packet for Oral Solution | SY | e5ef7b85-feee-44a7-bd0e-ed91352c7434 | 2 |
| 1189316 | acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution | SY | e5ef7b85-feee-44a7-bd0e-ed91352c7434 | 2 |
| 1659960 | acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Packet for Oral Solution | SY | e5ef7b85-feee-44a7-bd0e-ed91352c7434 | 2 |
| 1659960 | acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution | SY | e5ef7b85-feee-44a7-bd0e-ed91352c7434 | 2 |
| 1189316 | APAP 500 MG / Dextromethorphan Hydrobromide 20 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral Solution | SY | e5ef7b85-feee-44a7-bd0e-ed91352c7434 | 2 |
| 1659960 | APAP 650 MG / Diphenhydramine Hydrochloride 25 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral Solution | SY | e5ef7b85-feee-44a7-bd0e-ed91352c7434 | 2 |
| 1659960 | acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Granules for Oral Solution | PSN | 4daca846-8511-4303-9e6c-9469f7f260ba | 1 |
| 1659960 | acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution | SCD | 4daca846-8511-4303-9e6c-9469f7f260ba | 1 |
| 1659960 | acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Packet for Oral Solution | SY | 4daca846-8511-4303-9e6c-9469f7f260ba | 1 |
| 1659960 | acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution | SY | 4daca846-8511-4303-9e6c-9469f7f260ba | 1 |
| 1659960 | APAP 650 MG / Diphenhydramine Hydrochloride 25 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral Solution | SY | 4daca846-8511-4303-9e6c-9469f7f260ba | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0067-6803-02 | 00067680302 | 6 PACKET in 1 CARTON (0067-6803-02) / 237 mL in 1 PACKET | 6 packet | 2023-01-20 | No | No | Historical |