Theraflu
- Product NDC
- 0067-8212
- 11-digit product format
- 000678212
- Labeler code
- 0067
- Product ID
- 0067-8212_132a7bfc-7f1c-8436-e063-6394a90a5238
- 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
- 2023-05-01
- Substance
- ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 650; 25; 10 mg/1; mg/1; mg/1
- 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 362O9ITL9D | ACETAMINOPHEN | 103-90-2 | ACETAMINOPHEN |
| TC2D6JAD40 | DIPHENHYDRAMINE HYDROCHLORIDE | 147-24-0 | DIPHENHYDRAMINE HYDROCHLORIDE |
| 04JA59TNSJ | PHENYLEPHRINE HYDROCHLORIDE | 61-76-7 | PHENYLEPHRINE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0067-8212-01 | 00067821201 | 6 PACKET in 1 CARTON (0067-8212-01) / 1 POWDER, FOR SOLUTION in 1 PACKET | 6 packet | 2023-05-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Drug Facts | Haleon US Holdings LLC | 2024-03-08 | HUMAN OTC DRUG LABEL | 2 |