BIS II Tooth NDC 69653-200

NDC codes

FDA NDC Directory

Product NDC (as listed)69653-200Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69653-0200Add 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 NDC	11-digit (billing)	Package	Copy
69653-200-01	69653020001	20 g in 1 TUBE (69653-200-01)Marketed from Jan 1, 2026

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): BIS II Tooth
Generic name (nonproprietary): precipitated calcium carbonate, tocopherol acetate, aluminium chlorohydroxy allantoinate, dibasic calcium phosphate hydrate
Active ingredients: Dibasic calcium phosphate dihydrate — .04 g/100gCalcium carbonate — .1 g/100gAlcloxa — .04 g/100g.alpha.-tocopherol acetate — .04 g/100g
Dosage form: Paste, Dentifrice
Route: Dental
Labeler: Jewoo Medical CO.,LTD
Product type: Over-the-counter drug
Marketing category: Unapproved drug (other)
Marketing start: Jan 1, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Calcium (Chemical structure)Divalent (Chemical structure)Increased Coagulation Factor Activity (Physiologic effect)Phosphate Chelating Activity (Mechanism)
Identifiers: Product ID 69653-200_49e5f925-ddd6-f7b2-e063-6394a90af28aSPL ID 49e5f925-ddd6-f7b2-e063-6394a90af28aSPL set ID 49e5eeaa-7506-f42a-e063-6294a90a2864UNII O7TSZ97GEP, H0G9379FGK, 18B8O9DQA2, 9E8X80D2L0
Pharmacologic class: Blood Coagulation Factor; Phosphate Binder

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

N469653020001 followed by a unit qualifier and the quantity

Package 69653-0200-01. 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 Feb 3, 2026.

Indications (excerpt from the label)

Adults and children 2 yrs. older: Brush teeth thoroughly after meals or at least twice a day, or use as directed by a tentist or physician. Do not shallow. Children under 6 yrs.: To minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established. Children under 2 yrs.: Ask a dentist or physician.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)