Theraflu ExpressMax Severe Cold and Flu Caplets
- Product NDC
- 0067-8145
- 11-digit product format
- 000678145
- Labeler code
- 0067
- Product ID
- 0067-8145_131902a4-dd2f-09fa-e063-6294a90a3354
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Haleon US Holdings LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2017-07-17
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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 ExpressMax Severe Cold and Flu Caplets
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 325 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/1 |
| GUAIFENESIN | 200 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ |
| Rxcui | 1110988 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0067-8145-01 | Theraflu ExpressMax Severe Cold and Flu Caplets | 2 in 1 CARTON | TABLET, COATED | 2 | | 4 |
| 0067-8145-01 | Theraflu ExpressMax Severe Cold and Flu Caplets | 10 in 1 BLISTER PACK | TABLET, COATED | 10 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0067-8145 | THERAFLU EXPRESSMAX SEVERE COLD AND FLU CAPLETS (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [HALEON US HOLDINGS LLC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240308_8e22f6bc-33ce-4bb0-99be-7947aa21f60e.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 |
|---|
| 0067-8145-01 | 00067814501 | 2 BLISTER PACK in 1 CARTON (0067-8145-01) / 10 TABLET, COATED in 1 BLISTER PACK | 2 blister pack | 2017-07-17 | 0000-00-00 | No | No | Current |