Over-the-counter drug · UNAPPROVED HOMEOPATHIC
Cold Relief Drops (Pelargonium sidoides) NDC 53499-8271
Pelargonium sidoides root 1 [hp_X]/30mL · Liquid · Oral · Schwabe North America, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53499-8271-4 | 5349982710453499827104 | 1 BOTTLE, DROPPER in 1 CARTON (53499-8271-4) / 30 mL in 1 BOTTLE, DROPPERMarketed from Aug 26, 2024 | |
| 53499-8271-8 | 5349982710853499827108 | 1 BOTTLE, DROPPER in 1 CARTON (53499-8271-8) / 59 mL in 1 BOTTLE, DROPPERMarketed from Aug 26, 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)
- Cold Relief Drops
- Generic name (nonproprietary)
- pelargonium sidoides
- Active ingredients
- Pelargonium sidoides root — 1 [hp_X]/30mL
- Dosage form
- Liquid
- Route
- Oral
- Labeler
- Schwabe North America, Inc.NDC labeler code 53499
- Product type
- Over-the-counter drug
- Marketing category
- Unapproved homeopathic
- Marketing start
- Listing expires
- Identifiers
- Product ID 53499-8271_4c467925-b572-4736-8f6c-07b3eab5522eSPL ID 4c467925-b572-4736-8f6c-07b3eab5522eSPL set ID df3b5597-dc75-4736-be31-38f916414d76UNII H6J53HEX8EUPC 0033674157916
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
N453499827104followed by a unit qualifier and the quantityPackage 53499-8271-04. 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 Shortens duration and reduces severity of symptoms associated with the common cold and throat/nasal/bronchial irritations: chest congestion, nasal congestion, cough, hoarseness, sore throat.
Excerpt only. Read the full label for complete information.
About NDC 53499-8271
- What is NDC 53499-8271?
- 53499-8271 is the product NDC for Cold Relief Drops (pelargonium sidoides), Pelargonium sidoides root 1 [hp_X]/30mL liquid, listed with the FDA by Schwabe North America, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Cold Relief Drops (Pelargonium sidoides).
- What is the active ingredient?
- Pelargonium sidoides root.
- Who is the labeler?
- Schwabe North America, 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 Cold Relief Drops?
- 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.