Tesalon Jarabe Adulto
- Product NDC
- 69729-787
- 11-digit product format
- 697290787
- Labeler code
- 69729
- Product ID
- 69729-787_23e7c9c8-b746-038b-e063-6394a90ad40d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Dextromethorphan HBr, Guaifenesin USP, Phenylephrine HCl
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- OPMX LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-09-27
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 500; 26.66; 400; 10 mg/20mL; mg/20mL; mg/20mL; mg/20mL
- 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
- Tesalon Jarabe Adulto
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 500 mg/20mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 26.66 mg/20mL |
| GUAIFENESIN | 400 mg/20mL |
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/20mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ |
| Rxcui | 1790651 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69729-787-06 | Tesalon Jarabe Adulto | 177 mL in 1 BOTTLE, PLASTIC | SYRUP | 177 | | 2 |
| 69729-787-06 | Tesalon Jarabe Adulto | 1 in 1 CARTON | SYRUP | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69729-787 | TESALON JARABE ADULTO (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN USP, PHENYLEPHRINE HCL) SYRUP [OPMX LLC] | 2 | Current NDC, 2 package rows | 20241009_231c6455-4198-feec-e063-6394a90a8541.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 69729-787-06 | 69729078706 | 1 BOTTLE, PLASTIC in 1 CARTON (69729-787-06) / 177 mL in 1 BOTTLE, PLASTIC | 2024-09-27 | No | No | Current |