Childrens Tussnex
- Product NDC
- 53041-622
- 11-digit product format
- 530410622
- Labeler code
- 53041
- Product ID
- 53041-622_22aa8d0f-4ec8-431d-bdff-65eba6e76242
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acteaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Guardian Drug Company
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2012-05-05
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 10; 200; 5 mg/10mL; mg/10mL; mg/10mL; mg/10mL
- 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
- Childrens Tussnex
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/10mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/10mL |
| GUAIFENESIN | 200 mg/10mL |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/10mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 362O9ITL9D, 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ |
| Rxcui | 1593450 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53041-622-03 | Childrens Tussnex | 118 mL in 1 BOTTLE | LIQUID | 118 | 4 | |
| 53041-622-03 | Childrens Tussnex | 1 in 1 CARTON | LIQUID | 1 | 4 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 53041-622 | CHILDRENS TUSSNEX (ACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [GUARDIAN DRUG COMPANY] | 4 | Current NDC, Legacy NDC, 2 package rows | 20241222_19e9678d-ac34-4af8-a80f-d08fce0a5f0e.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1593450 | acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 10 mL Oral Suspension | PSN | 19e9678d-ac34-4af8-a80f-d08fce0a5f0e | 4 |
| 1593450 | acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Suspension | SCD | 19e9678d-ac34-4af8-a80f-d08fce0a5f0e | 4 |
| 1593450 | acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Suspension | SY | 19e9678d-ac34-4af8-a80f-d08fce0a5f0e | 4 |
| 1593450 | acetaminophen 650 MG / dextromethorphan hydrobromide 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral Suspension | SY | 19e9678d-ac34-4af8-a80f-d08fce0a5f0e | 4 |
| 1593450 | APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Suspension | SY | 19e9678d-ac34-4af8-a80f-d08fce0a5f0e | 4 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 53041-622-03 | 53041062203 | 1 BOTTLE in 1 CARTON (53041-622-03) / 118 mL in 1 BOTTLE | 1 bottle | 2012-05-05 | 0000-00-00 | No | No | Current |