Theraflu
- Product NDC
- 0067-7917
- 11-digit product format
- 000677917
- Labeler code
- 0067
- Product ID
- 0067-7917_1006345e-67d7-8b81-e063-6294a90ad7cd
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE
- Dosage form
- POWDER, FOR SOLUTION
- Route
- ORAL
- Labeler
- Haleon US Holdings LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2012-09-24
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 650; 20; 10 mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], 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
- Daytime Severe Cold and Cough
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 650 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, 9D2RTI9KYH, 04JA59TNSJ |
| Rxcui | 1659967 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0067-7917-06 | TherafluDaytime Severe Cold and Cough | 1 in 1 PACKET | POWDER, FOR SOLUTION | 1 | | 8 |
| 0067-7917-06 | TherafluDaytime Severe Cold and Cough | 6 in 1 CARTON | POWDER, FOR SOLUTION | 6 | | 8 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] | 1 | |
| DEXTROMETHORPHAN HYDROBROMIDE | ACTIVE INGREDIENT | 9D2RTI9KYH | THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] | 1 | |
| PHENYLEPHRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 04JA59TNSJ | THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] | 1 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] | 1 | |
| PHENYLEPHRINE | ACTIVE MOIETY | 1WS297W6MV | THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] | 1 | |
| ACESULFAME POTASSIUM | INACTIVE INGREDIENT | 23OV73Q5G9 | THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] | 1 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] | 1 | |
| ASPARTAME | INACTIVE INGREDIENT | Z0H242BBR1 | THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] | 1 | |
| FD&C BLUE NO. 1 | INACTIVE INGREDIENT | H3R47K3TBD | THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] | 1 | |
| MALTODEXTRIN | INACTIVE INGREDIENT | 7CVR7L4A2D | THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] | 1 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] | 1 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] | 1 | |
| TRIBASIC CALCIUM PHOSPHATE | INACTIVE INGREDIENT | 91D9GV0Z28 | THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [NOVARTIS CONSUMER HEALTH] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0067-7917 | THERAFLU DAYTIME SEVERE COLD AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN, PHENYLEPHRINE) POWDER, FOR SOLUTION [HALEON US HOLDINGS LLC] | 8 | Current NDC, Legacy NDC, 2 package rows | 20240129_c0689223-5c90-4dbc-bbfa-f94e267504c3.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 |
|---|
| 0067-7917-06 | 00067791706 | 6 PACKET in 1 CARTON (0067-7917-06) / 1 POWDER, FOR SOLUTION in 1 PACKET | 6 packet | 2012-09-24 | 0000-00-00 | No | No | Current |