Over-the-counter drug · UNAPPROVED HOMEOPATHIC
Allergy and Sinus Relief NDC 53499-4194
Pelargonium sidoides root 1 [hp_X]/1 + 5 more ingredients · Tablet, Chewable · Oral · Schwabe North American, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53499-4194-2 | 5349941940253499419402 | 2 BLISTER PACK in 1 CARTON (53499-4194-2) / 10 TABLET, CHEWABLE in 1 BLISTER PACKMarketed from Aug 1, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Allergy and Sinus Relief
- Generic name (nonproprietary)
- pelargonium sidoides root, hydrastis canadensis whole, potassium chloride, sanguinaria canadensis root, pulsatilla vulgaris, silicon dioxide
- Active ingredients
- Pelargonium sidoides root — 1 [hp_X]/1Hydrastis canadensis whole — 6 [hp_X]/1Potassium chloride — 3 [hp_X]/1Sanguinaria canadensis root — 6 [hp_X]/1Pulsatilla vulgaris — 6 [hp_X]/1Silicon dioxide — 6 [hp_X]/1
- Dosage form
- Tablet, Chewable
- Route
- Oral
- Labeler
- Schwabe North American, Inc.NDC labeler code 53499
- Product type
- Over-the-counter drug
- Marketing category
- Unapproved homeopathic
- Marketing start
- Listing expires
- Other FDA classes
- Increased Large Intestinal Motility (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Osmotic Activity (Mechanism)Potassium Compounds (Chemical structure)
- Identifiers
- Product ID 53499-4194_229f5cd4-f462-475f-819c-68883e543b16SPL ID 229f5cd4-f462-475f-819c-68883e543b16SPL set ID c90cc6f5-14ec-41a3-a20a-4e8018bb02fbUNII H6J53HEX8E, R763EBH88T, 660YQ98I10, N9288CD508, I76KB35JEV, ETJ7Z6XBU4UPC 0033674121948
- Pharmacologic class
- Osmotic Laxative; Potassium Salt
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
N453499419402followed by a unit qualifier and the quantityPackage 53499-4194-02. 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)
Indications & Usage Temporarily relieves allergy and sinus symptoms. Shortens duration and reduces severity of symptoms associated with the common cold and throat, nasal, bronchial irritations: cough, headache, hoarseness, sore throat, sinus pressure, chest congestion, nasal congestion, sneezing/runny nose, shrinks swollen nasal membranes, promotes sinus drainage, burning, itchy eyes, helps decongest sinus openings and passages.
Excerpt only. Read the full label for complete information.
About NDC 53499-4194
- What is NDC 53499-4194?
- 53499-4194 is the product NDC for Allergy and Sinus Relief, Pelargonium sidoides root 1 [hp_X]/1 + 5 more ingredients tablet, chewable, listed with the FDA by Schwabe North American, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Allergy and Sinus Relief (Pelargonium sidoides root, Hydrastis canadensis whole, Potassium chloride, Sanguinaria canadensis root, Pulsatilla vulgaris, Silicon dioxide).
- What is the active ingredient?
- Pelargonium sidoides root, Hydrastis canadensis whole, Potassium chloride, Sanguinaria canadensis root, Pulsatilla vulgaris, Silicon dioxide.
- Who is the labeler?
- Schwabe North American, Inc., NDC labeler code 53499. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Allergy and Sinus Relief?
- 1 other product NDC are listed under this name. See all Allergy and Sinus Relief NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Allergy and Sinus Relief products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Allergy and Sinus Reliefcetirizine hydrochloride, pseudoephedrine hydrochloride | Cetirizine hydrochloride 5 mg/1; Pseudoephedrine hydrochloride 120 mg/1 | Tablet, Film coated, Extended releaseOral | Kroger Company | 30142-633 | 30142-0633-62 |