Over-the-counter drug · OTC MONOGRAPH DRUG
Su Phedrine PE Sinus Congestion (Phenylephrine hcl) NDC 57243-953
Phenylephrine hydrochloride 10 mg/1 · Tablet, Film coated · Oral · Salado Sales, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57243-953-44 | 57243095344 | 1 BLISTER PACK in 1 CARTON (57243-953-44) / 18 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jan 15, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Su Phedrine PE Sinus CongestionSuffix: SINUS CONGESTION
- Generic name (nonproprietary)
- phenylephrine hcl
- Active ingredients
- Phenylephrine hydrochloride — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Salado Sales, Inc.NDC labeler code 57243
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 012
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha1-Agonists (Mechanism)
- Identifiers
- Product ID 57243-953_b0a8247f-07de-4c82-87aa-372e91b9aa25SPL ID b0a8247f-07de-4c82-87aa-372e91b9aa25SPL set ID ba075ff7-4e26-4856-8335-0c7dd4e198eaRxCUI 1049182UNII 04JA59TNSJUPC 0761706162163
- Pharmacologic class
- alpha-1 Adrenergic Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N457243095344followed by a unit qualifier and the quantityPackage 57243-0953-44. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Uses temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves sinus congestion and pressure
Excerpt only. Read the full label for complete information.
About NDC 57243-953
- What is NDC 57243-953?
- 57243-953 is the product NDC for Su Phedrine PE Sinus Congestion (phenylephrine hcl), Phenylephrine hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by Salado Sales, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Su Phedrine PE Sinus Congestion (Phenylephrine HCl).
- What is the active ingredient?
- Phenylephrine hydrochloride.
- Who is the labeler?
- Salado Sales, Inc., NDC labeler code 57243. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Su Phedrine PE Sinus Congestion?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under M 012
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| topcare tussin cf maxacetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride | Acetaminophen 650 mg/20mL + 3 more ingredients | SolutionOral | Topco Associates LLC | 76162-000 |
| SEVERE CONGESTION and COUGH MAXdextromethorphan hbr, guaifenesin, phenylephrine hcl | Dextromethorphan hydrobromide 20 mg/20mL + 2 more ingredients | LiquidOral | AptaPharma Inc. | 76281-517 |
| Nighttime Cold And Flu Reliefacetaminophen, dextromethorphan hydrobromide, and doxylamine succinate | Dextromethorphan hydrobromide 15 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | Advanced Rx LLC | 80513-304 |
| Quality Choice Mucus Reliefguaifenesin | Guaifenesin 400 mg/1 | TabletOral | Chain Drug Marketing Association | 83324-194 |
| Pseudoephedrine Hydrochloride | Pseudoephedrine hydrochloride 60 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6728 |
| Nighttime Cold and Flu Liquidacetaminophen, dextromethorphan hydrobromide, doxylamine succinate | Acetaminophen 650 mg/30mL + 2 more ingredients | LiquidOral | TARGET CORPORATION | 11673-287 |
| Allergy Reliefdiphenhydramine hcl | Diphenhydramine hydrochloride 25 mg/1 | TabletOral | TARGET CORPORATION | 11673-494 |
| Mucus Reliefguaifenesin | Guaifenesin 400 mg/1 | TabletOral | KROGER COMPANY | 41226-272 |
| sinus pressure and pain peacetaminophen and phenylephrine hydrochloride | Acetaminophen 325 mg/1; Phenylephrine hydrochloride 5 mg/1 | Tablet, CoatedOral | GOODSENSE | 50804-220 |
| Mucinex Sinus-Max Severe Congestion Reliefacetaminophen, guaifenesin, and phenylephrine hydrochloride | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, CoatedOral | Reckitt Benckiser LLC | 63824-201 |
| Oxymetazoline Hydrochloride | Oxymetazoline hydrochloride .05 g/100mL | SprayNasal | CHAIN DRUG MARKETING ASSOCIATION INC. | 63868-676 |
| Childrens Wal Tap Elixer Cold and Allergybrompheniramine maleate, phenylephrine hcl | Brompheniramine maleate 2 mg/10mL; Phenylephrine hydrochloride 5 mg/10mL | LiquidOral | Walgreens | 0363-0312 |
| Vicks NyQuil Kids BERRY COLD and COUGH plus RUNNY NOSEchlorpheniramine maleate, dextromethorphan hbr | Chlorpheniramine maleate 2 mg/15mL; Dextromethorphan hydrobromide 15 mg/15mL | LiquidOral | The Procter & Gamble Manufacturing Company | 69423-779 |
| Night-Time Cold and Flu Reliefacetaminophen, doxylamine succinate, dextromethorphan hbr | Acetaminophen 325 mg/1 + 2 more ingredients | Capsule, Liquid filledOral | HealthLife of USA | 69517-161 |
| Tylenol Sinus Severeacetaminophen | Acetaminophen 325 mg/1 + 2 more ingredients | Tablet, CoatedOral | R J General Corporation | 70264-026 |
| Tussin Expectorantguaifenesin | Guaifenesin 100 mg/5mL | LiquidOral | AptaPharma, Inc. | 76281-507 |
| ValuMeds Allergy Relief Antihistamine Diphenhydramine HCldiphenhydramine hydrochloride | Diphenhydramine hydrochloride 25 mg/1 | TabletOral | Cabinet Health P.B.C. | 82725-1101 |
| Equate Severe Menthol Throat Dropmenthol | Menthol 20 mg/1 | LozengeOral | Walmart | 79903-254 |
| Nighttime Cold And Flu Relief Softgels Multi-Symptomacetaminophen, dextromethorphan hbr, doxylamine succinate | Dextromethorphan hydrobromide 15 mg/1 + 2 more ingredients | Capsule, Gelatin coatedOral | Advanced Rx LLC | 80513-302 |
| Vicks NyQuil-D COLD and SINUS plus SEVERE CONGESTIONacetaminophen, pseudoephedrine hcl, doxylamine succinate, dextromethorphan hbr | Doxylamine succinate 6.25 mg/1 + 3 more ingredients | Capsule, Liquid filledOral | The Procter & Gamble Manufacturing Company | 84126-364 |
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