Theraflu
- Product NDC
- 0067-0105
- 11-digit product format
- 000670105
- Labeler code
- 0067
- Product ID
- 0067-0105_438014e3-6d78-1332-e063-6394a90afc47
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Diphenhydramine HCl
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Haleon US Holdings LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-12-01
- Substance
- ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
- Active strength
- 650; 25 mg/30mL; mg/30mL
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [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/30mL |
| DIPHENHYDRAMINE HYDROCHLORIDE | 25 mg/30mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 362O9ITL9D, TC2D6JAD40 |
| Rxcui | 1294607 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0e2e0f88-b076-afe1-4bdd-32bca4375bec | Product name | 3 | 20250127 |
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
| 3e48c9c4-918d-5d23-2f0b-d2398b06be54 | Product name | 1 | 20140508 |
| 865c72dd-0d94-daac-f728-ddd4ded2a79e | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0067-0105-08 | TherafluSevere Cold Relief Nighttime | 245.5 mL in 1 BOTTLE | SYRUP | 245.5 | 4 | |
| 0067-0105-08 | TherafluSevere Cold Relief | 245.5 mL in 1 BOTTLE | SYRUP | 1 mL | 650 mg in 30mL | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0067-0105 | THERAFLU SEVERE COLD RELIEF NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) SYRUP [HALEON US HOLDINGS LLC] | 3 | Current NDC, 1 package rows | 20250116_c24b9489-208c-472b-8ae5-c6e86c12e04d.zip |
| 0067-0105 | THERAFLU SEVERE COLD RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENPHYDRAMINE HCL, GUAIFENESIN) KIT [HALEON US HOLDINGS LLC] | 1 | Current NDC | 20241016_b01cc9f5-53f2-40d8-acf1-6de180b3d0bf.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1294607 | acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG in 30 mL Oral Solution | PSN | c24b9489-208c-472b-8ae5-c6e86c12e04d | 4 |
| 1294607 | acetaminophen 21.7 MG/ML / diphenhydramine hydrochloride 0.833 MG/ML Oral Solution | SCD | c24b9489-208c-472b-8ae5-c6e86c12e04d | 4 |
| 1294607 | APAP 21.7 MG/ML / Diphenhydramine Hydrochloride 0.833 MG/ML Oral Solution | SY | c24b9489-208c-472b-8ae5-c6e86c12e04d | 4 |
| 1294607 | APAP 325 MG / diphenhydramine hydrochloride 12.5 MG per 15 ML Oral Solution | SY | c24b9489-208c-472b-8ae5-c6e86c12e04d | 4 |
| 2695452 | {1 (acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML Oral Solution) / 1 (acetaminophen 21.7 MG/ML / diphenhydramine hydrochloride 0.833 MG/ML Oral Solution) } Pack | GPCK | b01cc9f5-53f2-40d8-acf1-6de180b3d0bf | 1 |
| 2695452 | 1 daytime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 in 30 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG in 30 mL Oral Solution) Pack | PSN | b01cc9f5-53f2-40d8-acf1-6de180b3d0bf | 1 |
| 1042695 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 30 mL Oral Solution | PSN | b01cc9f5-53f2-40d8-acf1-6de180b3d0bf | 1 |
| 1294607 | acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG in 30 mL Oral Solution | PSN | b01cc9f5-53f2-40d8-acf1-6de180b3d0bf | 1 |
| 1042695 | acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML Oral Solution | SCD | b01cc9f5-53f2-40d8-acf1-6de180b3d0bf | 1 |
| 1294607 | acetaminophen 21.7 MG/ML / diphenhydramine hydrochloride 0.833 MG/ML Oral Solution | SCD | b01cc9f5-53f2-40d8-acf1-6de180b3d0bf | 1 |
| 2695452 | 1 daytime (acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 per 30 mL Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG per 30 mL Oral Solution) Pack | SY | b01cc9f5-53f2-40d8-acf1-6de180b3d0bf | 1 |
| 1042695 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG in 15 mL Oral Solution | SY | b01cc9f5-53f2-40d8-acf1-6de180b3d0bf | 1 |
| 1042695 | acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG in 30 mL Oral Solution | SY | b01cc9f5-53f2-40d8-acf1-6de180b3d0bf | 1 |
| 1042695 | APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / Guaifenesin 13.3 MG/ML Oral Solution | SY | b01cc9f5-53f2-40d8-acf1-6de180b3d0bf | 1 |
| 1294607 | APAP 21.7 MG/ML / Diphenhydramine Hydrochloride 0.833 MG/ML Oral Solution | SY | b01cc9f5-53f2-40d8-acf1-6de180b3d0bf | 1 |
| 1294607 | APAP 325 MG / diphenhydramine hydrochloride 12.5 MG per 15 ML Oral Solution | SY | b01cc9f5-53f2-40d8-acf1-6de180b3d0bf | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0067-0105-08 | 00067010508 | 245.5 mL in 1 BOTTLE (0067-0105-08) | 245.5 ml | 2023-12-01 | No | No | Historical |