SU PHEDRINE PE
- Product NDC
- 57243-453
- 11-digit product format
- 572430453
- Labeler code
- 57243
- Product ID
- 57243-453_5ae58203-4d1e-42ed-bbbe-e27aca71dc91
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Phenylephrine HCl
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Salado Sales, Inc.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2005-01-14
- Marketing end
- 2026-11-30
- Substance
- PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SU PHEDRINE PE
- Brand name suffix
- Non-Drowsy, Maximum Strength
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PHENYLEPHRINE HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 04JA59TNSJ |
| Rxcui | 1049182 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 57243-453-44 | SU PHEDRINE PENon-Drowsy, Maximum Strength | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 15 |
| 57243-453-44 | SU PHEDRINE PENon-Drowsy, Maximum Strength | 18 in 1 BLISTER PACK | TABLET, FILM COATED | 18 | | 15 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PHENYLEPHRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 04JA59TNSJ | SU PHEDRINE PE NON-DROWSY, MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] | 2 | |
| PHENYLEPHRINE | ACTIVE MOIETY | 1WS297W6MV | SU PHEDRINE PE NON-DROWSY, MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] | 2 | |
| CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE | INACTIVE INGREDIENT | O7TSZ97GEP | SU PHEDRINE PE NON-DROWSY, MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] | 2 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | SU PHEDRINE PE NON-DROWSY, MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] | 2 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | SU PHEDRINE PE NON-DROWSY, MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] | 2 | |
| DEXTROSE MONOHYDRATE | INACTIVE INGREDIENT | LX22YL083G | SU PHEDRINE PE NON-DROWSY, MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] | 2 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | SU PHEDRINE PE NON-DROWSY, MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SU PHEDRINE PE NON-DROWSY, MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] | 2 | |
| MALTODEXTRIN | INACTIVE INGREDIENT | 7CVR7L4A2D | SU PHEDRINE PE NON-DROWSY, MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | SU PHEDRINE PE NON-DROWSY, MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57243-453 | SU PHEDRINE PE NON-DROWSY, MAXIMUM STRENGTH (PHENYLEPHRINE HCL) TABLET, FILM COATED [SALADO SALES, INC.] | 14 | Current NDC, Legacy NDC, 2 package rows | 20250117_9056fa58-d6aa-4df5-97e0-9be3f2332f86.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 |
|---|
| 57243-453-44 | 57243045344 | 1 BLISTER PACK in 1 CARTON (57243-453-44) / 18 TABLET, FILM COATED in 1 BLISTER PACK | 1 blister pack | 2005-01-14 | 2026-11-30 | No | No | Current |