PRO-RED
- Product NDC
- 66594-499
- 11-digit product format
- 665940499
- Labeler code
- 66594
- Product ID
- 66594-499_cc958709-6208-4ae0-8d57-2361bf78d826
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Codeine Phosphate, Dexchorpheniramine Maleate, Phenylephrine Hydrochloride
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- Pro-Pharma, LLC
- Application
- part341
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2013-09-30
- Marketing end
- 0000-00-00
- Substance
- CODEINE PHOSPHATE; DEXCHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 9 mg/5mL; mg/5mL; mg/5mL
- DEA schedule
- CV
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 66594-499-01 | PRO-REDAC | 30 mL in 1 BOTTLE | SYRUP | 30 | | 1 |
| 66594-499-16 | PRO-REDAC | 473 mL in 1 BOTTLE | SYRUP | 473 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Codeine Phosphate | ACTIVE INGREDIENT | GSL05Y1MN6 | PRO-RED AC (CODEINE PHOSPHATE, DEXCHORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PRO-PHARMA, LLC] | 1 | |
| DEXCHLORPHENIRAMINE MALEATE | ACTIVE INGREDIENT | B10YD955QW | PRO-RED AC (CODEINE PHOSPHATE, DEXCHORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PRO-PHARMA, LLC] | 1 | |
| PHENYLEPHRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 04JA59TNSJ | PRO-RED AC (CODEINE PHOSPHATE, DEXCHORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PRO-PHARMA, LLC] | 1 | |
| CODEINE ANHYDROUS | ACTIVE MOIETY | UX6OWY2V7J | PRO-RED AC (CODEINE PHOSPHATE, DEXCHORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PRO-PHARMA, LLC] | 1 | |
| DEXCHLORPHENIRAMINE | ACTIVE MOIETY | 3Q9Q0B929N | PRO-RED AC (CODEINE PHOSPHATE, DEXCHORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PRO-PHARMA, LLC] | 1 | |
| PHENYLEPHRINE | ACTIVE MOIETY | 1WS297W6MV | PRO-RED AC (CODEINE PHOSPHATE, DEXCHORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PRO-PHARMA, LLC] | 1 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | PRO-RED AC (CODEINE PHOSPHATE, DEXCHORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PRO-PHARMA, LLC] | 1 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | PRO-RED AC (CODEINE PHOSPHATE, DEXCHORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PRO-PHARMA, LLC] | 1 | |
| Propylene Glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | PRO-RED AC (CODEINE PHOSPHATE, DEXCHORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PRO-PHARMA, LLC] | 1 | |
| Saccharin Sodium | INACTIVE INGREDIENT | SB8ZUX40TY | PRO-RED AC (CODEINE PHOSPHATE, DEXCHORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PRO-PHARMA, LLC] | 1 | |
| Sodium Citrate | INACTIVE INGREDIENT | 1Q73Q2JULR | PRO-RED AC (CODEINE PHOSPHATE, DEXCHORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PRO-PHARMA, LLC] | 1 | |
| Sorbitol | INACTIVE INGREDIENT | 506T60A25R | PRO-RED AC (CODEINE PHOSPHATE, DEXCHORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PRO-PHARMA, LLC] | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | PRO-RED AC (CODEINE PHOSPHATE, DEXCHORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PRO-PHARMA, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 66594-499 | PRO-RED AC (CODEINE PHOSPHATE, DEXCHORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE) SYRUP [PRO-PHARMA, LLC] | 1 | Legacy NDC, 2 package rows | 20131008_72355a55-e1b9-4004-9d2d-e215f947946e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 66594-499-01 | 66594049901 | 30 mL in 1 BOTTLE | 30 ml | Historical |
| 66594-499-16 | 66594049916 | 473 mL in 1 BOTTLE | 473 ml | Historical |