THERAFLU
- Product NDC
- 0067-6095
- 11-digit product format
- 000676095
- Labeler code
- 0067
- Product ID
- 0067-6095_102bd52f-def1-ca60-e063-6294a90a1d4d
- 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
- 2018-07-28
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- THERAFLU
- Brand name suffix
- POWERPODS NIGHTTIME SEVERE COLD
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 650 mg/1 |
| DIPHENHYDRAMINE HYDROCHLORIDE | 25 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, TC2D6JAD40, 04JA59TNSJ |
| Rxcui | 1659960 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0067-6095-01 | THERAFLUPOWERPODS NIGHTTIME SEVERE COLD | 8 in 1 CARTON | POWDER, FOR SOLUTION | 8 | | 7 |
| 0067-6095-02 | THERAFLUPOWERPODS NIGHTTIME SEVERE COLD | 1 in 1 POUCH | POWDER, FOR SOLUTION | 1 | | 7 |
| 0067-6095-03 | THERAFLUPOWERPODS NIGHTTIME SEVERE COLD | 1 in 1 CARTON | POWDER, FOR SOLUTION | 1 | | 7 |
| 0067-6095-03 | THERAFLUPOWERPODS NIGHTTIME SEVERE COLD | 1 in 1 POUCH | POWDER, FOR SOLUTION | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0067-6095 | THERAFLU POWERPODS NIGHTTIME SEVERE COLD (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [HALEON US HOLDINGS LLC] | 7 | Current NDC, Legacy NDC, 4 package rows | 20240131_39f9feef-4bf2-4f10-9fff-22bbb1d8a471.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0067-6095-01 | 00067609501 | 8 POUCH in 1 CARTON (0067-6095-01) / 1 POWDER, FOR SOLUTION in 1 POUCH (0067-6095-02) | 8 pouch | 2018-07-28 | 0000-00-00 | No | No | Current |
| 0067-6095-02 | 00067609502 | 1 in 1 POUCH | | | | | | Historical |
| 0067-6095-03 | 00067609503 | 1 POUCH in 1 CARTON (0067-6095-03) / 1 POWDER, FOR SOLUTION in 1 POUCH | 1 pouch | 2019-01-20 | 0000-00-00 | No | No | Current |