Over-the-counter drug · NDA
Voltaren Arthritis Pain (Diclofenac sodium) NDC 0067-8154
Kit · Haleon US Holdings LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0067-8154-01 | 00067815401 | 1 KIT in 1 CARTON (0067-8154-01) * 1 TUBE in 1 CARTON (0067-8152-03) / 100 g in 1 TUBE * 1 TUBE in 1 CARTON (0067-8152-01) / 20 g in 1 TUBEMarketed from Feb 19, 2025 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Voltaren Arthritis PainSuffix: Arthritis Pain
- Generic name (nonproprietary)
- diclofenac sodium
- Dosage form
- Kit
- Labeler
- Haleon US Holdings LLCNDC labeler code 0067
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022122
- Marketing start
- Listing expires
- Identifiers
- Product ID 0067-8154_71ee74f6-1c1d-4ba8-95be-9b9aefc02d3cSPL ID 71ee74f6-1c1d-4ba8-95be-9b9aefc02d3cSPL set ID 30a94282-0892-442a-aa10-6525cbd4fe88RxCUI 855633, 855635UNII QTG126297Q
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
N400067815401followed by a unit qualifier and the quantityPackage 00067-8154-01. 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 arthritis pain ONLY in the following areas: o hand, wrist, elbow (upper body areas) o foot, ankle, knee (lower body areas) • this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use.
Excerpt only. Read the full label for complete information.
About NDC 0067-8154
- What is NDC 0067-8154?
- 0067-8154 is the product NDC for Voltaren Arthritis Pain (diclofenac sodium) kit, listed with the FDA by Haleon US Holdings LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Voltaren Arthritis Pain (Diclofenac sodium).
- Who is the labeler?
- Haleon US Holdings LLC, NDC labeler code 0067. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Voltaren Arthritis Pain?
- 2 other product NDCs are listed under this name. See all Voltaren Arthritis Pain NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Voltaren Arthritis Pain products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Voltaren Arthritis Paindiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Haleon US Holdings LLC | 0067-8152 | 00067-8152-0100067-8152-0200067-8152-03+3 more |
| Voltaren Arthritis Paindiclofenac sodium | — | Kit | Haleon US Holdings LLC | 0067-8153 | 00067-8153-01 |
Other NDCs under NDA 022122
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 |
|---|---|---|---|---|
| Voltaren Arthritis Paindiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Haleon US Holdings LLC | 0067-8152 |
| Voltaren Arthritis Paindiclofenac sodium | — | Kit | Haleon US Holdings LLC | 0067-8153 |
| Diclofenac Sodium | Diclofenac sodium 10 mg/g | GelTopical | Proficient Rx LP | 63187-753 |