Over-the-counter drug · OTC MONOGRAPH DRUG
Koala Pals Berrylicious (Sodium fluoride) NDC 54473-300
Sodium fluoride .2592 g/108g · Paste, Dentifrice · Topical · Melaleuca, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54473-300-04 | 54473030004 | 108 g in 1 TUBE (54473-300-04)Marketed from Jan 1, 2018 |
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)
- Koala Pals BerryliciousSuffix: Berrylicious
- Generic name (nonproprietary)
- sodium fluoride
- Active ingredients
- Sodium fluoride — .2592 g/108g
- Dosage form
- Paste, Dentifrice
- Route
- Topical
- Labeler
- Melaleuca, Inc.NDC labeler code 54473
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 021
- Marketing start
- Listing expires
- Identifiers
- Product ID 54473-300_4746e0a5-a9c5-c828-e063-6394a90ada98SPL ID 4746e0a5-a9c5-c828-e063-6394a90ada98SPL set ID 6624be86-c9a8-53b8-e053-2a91aa0a87efRxCUI 416783UNII 8ZYQ1474W7
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
N454473030004followed by a unit qualifier and the quantityPackage 54473-0300-04. 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)
Use aids in the prevention of cavities
Excerpt only. Read the full label for complete information.
About NDC 54473-300
- What is NDC 54473-300?
- 54473-300 is the product NDC for Koala Pals Berrylicious (sodium fluoride), Sodium fluoride .2592 g/108g paste, dentifrice, listed with the FDA by Melaleuca, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Koala Pals Berrylicious (Sodium Fluoride).
- What is the active ingredient?
- Sodium fluoride.
- Who is the labeler?
- Melaleuca, Inc., NDC labeler code 54473. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Koala Pals Berrylicious?
- 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.
Other NDCs under M 021
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Auraglow Whiteningsodium fluoride | Sodium fluoride 2.3 mg/g | Paste, DentifriceDental | Auraglow LLC | 81740-003 |
| Crayola ANTICAVITY STRAWBERRY FLAVORsodium fluoride | Sodium fluoride .243 g/100g | Paste, DentifriceDental | Ashtel Studios, Inc. | 70108-080 |
| Made by Dentists For Kids Eyeball Juice (Watermelon)sodium fluoride | Sodium fluoride 1.5 mg/g | PasteDental | MADE BY DENTISTS INC | 75065-030 |
| White Glo Advantage Anticavity Professional Whiteningsodium monofluorophosphate | Sodium monofluorophosphate 7.6 mg/g | PasteTopical | WHITE GLO USA INC | 73656-027 |
| AutoBrush Mintsodium fluoride | Sodium fluoride .243 g/100mL | LiquidOral | Lander Enterprises, LLC | 82913-011 |
| Hello Unicorn Splashsodium fluoride | Sodium fluoride .02 g/100mL | MouthwashDental | Accupac LLC | 44038-0687 |
| Crest 3D White Stain Eraser Icy Clean Mintsodium fluoride | Sodium fluoride 1.5 mg/g | Paste, DentifriceOral | The Procter & Gamble Manufacturing Company | 69423-773 |
| White Glo Professional Choice Twin Packsodium fluoride | — | Kit | WHITE GLO USA INC | 73656-024 |
| Therabreath Healthy Gumsstannous fluoride | Stannous fluoride .454 g/100g | Paste, DentifriceOral | Church & Dwight Co., Inc. | 10237-271 |
| Crest 3D White Vibrant Mintsodium fluoride | Sodium fluoride 1.5 mg/g | Paste, DentifriceOral | The Procter & Gamble Manufacturing Company | 69423-774 |
| Complete Protectionstannous fluoride | Stannous fluoride .15 g/100g | Paste, DentifriceDental, Oral | Target | 11673-366 |
| Anticavitysodium fluoride | Sodium fluoride .1 mg/mL | RinseOral | H E B | 37808-119 |
| Listerine Total Care Alcohol Free Anticavity Fluoride Mouthwash Fresh Mintsodium fluoride | Sodium fluoride .1 mg/mL | MouthwashOral | Kenvue Brands LLC | 69968-0924 |
| White Glo Advantage Anticavity Fluoride Purplesodium monofluorophosphate | Sodium monofluorophosphate 7.6 mg/g | PasteTopical | WHITE GLO USA INC | 73656-026 |
| Hismilesodium fluoride | Sodium fluoride .243 g/100g | GelDental | HISMILE PTY LTD | 83013-321 |
| Delta Comfort Plus Amenitysodium monofluorophosphate | — | Kit | Buzz Products Inc. | 69491-043 |
| Hismilebanana flavor sodium fluoride anticavity toothpaste | Sodium fluoride 2.4 mg/g | GelDental | Hismile Pty Ltd | 83013-319 |
| TP OW Stainfighter Clean Mintsodium fluoride | Sodium fluoride 1.1 mg/g | Paste, DentifriceDental | Colgate-Palmolive Company | 35000-999 |
| Sodium Fluoride | Sodium fluoride 2.43 mg/g | Paste, DentifriceDental | Safco Dental Supply LLC | 67239-0226 |
| Delta Travel Kit Comfort plussodium monofluorophosphate | — | Kit | Buzz Products Inc. | 69491-039 |
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