NDC codes

FDA NDC Directory
Product NDC (as listed)53499-8271Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53499-8271Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
53499-8271-453499827104534998271041 BOTTLE, DROPPER in 1 CARTON (53499-8271-4) / 30 mL in 1 BOTTLE, DROPPERMarketed from Aug 26, 2024
53499-8271-853499827108534998271081 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

N453499827104 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in