NDC codes

FDA NDC Directory
Product NDC (as listed)61077-127Labeler and product segments. Claims need a package NDC.
Product NDC at billing width61077-0127Add 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
61077-127-116107701271111 mL in 1 BOTTLE, DROPPER (61077-127-11)Marketed from Nov 6, 2013
61077-127-336107701273333 mL in 1 BOTTLE, DROPPER (61077-127-33)Marketed from Nov 6, 2013

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)
H-Cold Sores Formula
Generic name (nonproprietary)
calendula officinalis, ranunculus bulbosus
Active ingredients
Calendula officinalis flowering top — 12 [hp_C]/11mLRanunculus bulbosus — 12 [hp_C]/11mL
Dosage form
Oil
Route
Topical
Labeler
Healing Natural Oils LLCNDC labeler code 61077
Product type
Over-the-counter drug
Marketing category
Unapproved homeopathic
Marketing start
Listing expires
Identifiers
Product ID 61077-127_2906ca73-43de-2c24-e063-6294a90a7bf2SPL ID 2906ca73-43de-2c24-e063-6294a90a7bf2SPL set ID 425bc0e8-c884-40cc-90e9-490e50f733c3UNII 18E7415PXQ, AEQ8NXJ0MB

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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N461077012711 followed by a unit qualifier and the quantity

Package 61077-0127-11. 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: For the treatment of cold sore symptoms, such as fever blisters, soreness at blister site.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 61077-127

What is NDC 61077-127?
61077-127 is the product NDC for H-Cold Sores Formula, Calendula officinalis flowering top 12 [hp_C]/11mL; Ranunculus bulbosus 12 [hp_C]/11mL oil, listed with the FDA by Healing Natural Oils LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
H-Cold Sores Formula (Calendula officinalis, ranunculus bulbosus).
What is the active ingredient?
Calendula officinalis flowering top, Ranunculus bulbosus.
Who is the labeler?
Healing Natural Oils LLC, NDC labeler code 61077. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for H-Cold Sores Formula?
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.

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