CHILDRENS COLD COUGH and SORE THROAT MIXED BERRY
- Product NDC
- 76281-519
- 11-digit product format
- 762810519
- Labeler code
- 76281
- Product ID
- 76281-519_2f25ce5a-4e46-4e77-be6d-041a502a5049
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN, DEXTROMETHORPHAN HBr, GUAIFENESIN, PHENYLEPHRINE HCL
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- AptaPharma Inc.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-01-30
- 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 COLD COUGH and SORE THROAT MIXED BERRY
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 325 mg/10mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/10mL |
| GUAIFENESIN | 200 mg/10mL |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/10mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ |
| Rxcui | 1593450 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76281-519-24 | CHILDRENS COLD COUGH and SORE THROAT MIXED BERRY | 1 in 1 CARTON | LIQUID | 1 | | 2 |
| 76281-519-24 | CHILDRENS COLD COUGH and SORE THROAT MIXED BERRY | 118 mL in 1 BOTTLE | LIQUID | 118 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76281-519 | CHILDRENS COLD COUGH AND SORE THROAT MIXED BERRY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) LIQUID [APTAPHARMA INC.] | 2 | Current NDC, 2 package rows | 20240202_5962a73e-72e4-493b-94a7-43bc6cf9c82f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 76281-519-24 | 76281051924 | 1 BOTTLE in 1 CARTON (76281-519-24) / 118 mL in 1 BOTTLE | 1 bottle | 2024-01-30 | No | No | Current |