NDC codes

FDA NDC Directory
Product NDC (as listed)83004-046Labeler and product segments. Claims need a package NDC.
Product NDC at billing width83004-0046Add 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
83004-046-01830040046017 APPLICATOR in 1 BOX (83004-046-01) / 8.5 g in 1 APPLICATORMarketed from Dec 12, 2024
83004-046-028300400460220 APPLICATOR in 1 BOX (83004-046-02) / 8.5 g in 1 APPLICATORMarketed from Dec 12, 2024

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

Generic name (nonproprietary)
olive extract,hydrastis,borax,calendula officinalis
Active ingredients
Olea europaea (Olive) leaf powder — 3 [hp_X]/8.5gGoldenseal — 5 [hp_X]/8.5gSodium borate — 3 [hp_X]/8.5gCalendula officinalis flowering top — 1 [hp_X]/8.5g
Dosage form
Gel
Route
Vaginal
Labeler
Rida LLCNDC labeler code 83004
Product type
Over-the-counter drug
Marketing category
Unapproved homeopathic
Marketing start
Listing expires
Identifiers
Product ID 83004-046_563141e4-6d00-0caa-e063-6394a90ac241SPL ID 563141e4-6d00-0caa-e063-6394a90ac241SPL set ID 5c42c8ae-3610-4fc9-b764-ccf22340d9ceUNII MJ95C3OH47, ZW3Z11D0JV, 91MBZ8H3QO, 18E7415PXQ

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N483004004601 followed by a unit qualifier and the quantity

Package 83004-0046-01. 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 For the temporary relief of minor vaginal discomfort and feelings of irritation.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 83004-046

What is NDC 83004-046?
83004-046 is the product NDC for Terramed Just Think Comfort GynoCare BV Guard Vaginal Symptoms Relief, Olea europaea (Olive) leaf powder 3 [hp_X]/8.5g + 3 more ingredients gel, listed with the FDA by Rida LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Terramed Just Think Comfort GynoCare BV Guard Vaginal Symptoms Relief (Olive Extract,Hydrastis,Borax,Calendula Officinalis).
What is the active ingredient?
Olea europaea (Olive) leaf powder, Goldenseal, Sodium borate, Calendula officinalis flowering top.
Who is the labeler?
Rida LLC, NDC labeler code 83004. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Terramed Just Think Comfort GynoCare BV Guard Vaginal Symptoms Relief?
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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