Nasal Decongestant PE
- Product NDC
- 41163-453
- 11-digit product format
- 411630453
- Labeler code
- 41163
- Product ID
- 41163-453_f8421ade-2d03-42bf-a048-5a8120d63c31
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Phenylephrine HCl
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- SUPERVALU INC.
- Application
- part341
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2005-01-14
- Marketing end
- 0000-00-00
- Substance
- PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 10 mg/1
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| PHENYLEPHRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 04JA59TNSJ | NASAL DECONGESTANT PE (PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.] | 3 | |
| PHENYLEPHRINE | ACTIVE MOIETY | 1WS297W6MV | NASAL DECONGESTANT PE (PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.] | 3 | |
| CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE | INACTIVE INGREDIENT | O7TSZ97GEP | NASAL DECONGESTANT PE (PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | NASAL DECONGESTANT PE (PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.] | 3 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | NASAL DECONGESTANT PE (PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.] | 3 | |
| DEXTROSE MONOHYDRATE | INACTIVE INGREDIENT | LX22YL083G | NASAL DECONGESTANT PE (PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.] | 3 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | NASAL DECONGESTANT PE (PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | NASAL DECONGESTANT PE (PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.] | 3 | |
| MALTODEXTRIN | INACTIVE INGREDIENT | 7CVR7L4A2D | NASAL DECONGESTANT PE (PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | NASAL DECONGESTANT PE (PHENYLEPHRINE HCL) TABLET, FILM COATED [SUPERVALU INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 41163-453 | NASAL DECONGESTANT PE (PHENYLEPHRINE HCL) TABLET, FILM COATED [UNITED NATURAL FOODS, INC. DBA UNFI] | 12 | Legacy NDC | 20241207_3f221704-7bfc-4ea8-b021-5e9f45c07578.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 41163-453-07 | 41163045307 | 2 BLISTER PACK in 1 CARTON (41163-453-07) > 18 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2005-01-14 | 0000-00-00 | No | No | Current |