Over-the-counter drug · ANDA
Diclofenac Sodium Topical (diclofenac sodium) NDC 51316-804
Diclofenac sodium 10 mg/g · Gel · Topical · CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51316-804-01 | 51316080401 | 1 TUBE in 1 CARTON (51316-804-01) / 100 g in 1 TUBEMarketed from Oct 14, 2025 | |
| 51316-804-02 | 51316080402 | 1 TUBE in 1 CARTON (51316-804-02) / 50 g in 1 TUBEMarketed from Sep 8, 2025 | |
| 51316-804-03 | 51316080403 | 1 TUBE in 1 CARTON (51316-804-03) / 150 g in 1 TUBEMarketed from May 13, 2025 |
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)
- Diclofenac Sodium Topical
- Generic name (nonproprietary)
- diclofenac sodium
- Active ingredients
- Diclofenac sodium — 10 mg/g
- Dosage form
- Gel
- Route
- Topical
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211253
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
- Identifiers
- Product ID 51316-804_caa8dc8f-4b10-4098-957d-c9ab06dfec03SPL ID caa8dc8f-4b10-4098-957d-c9ab06dfec03SPL set ID 181e32ab-5ec0-4be4-bad0-b6bbafc08f85RxCUI 855633UNII QTG126297Q
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug
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
N451316080401followed by a unit qualifier and the quantityPackage 51316-0804-01. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 211253
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 |
|---|---|---|---|---|
| topcare athritis pain relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Topco Associates LLC | 36800-526 |
| Arthritis Pain Relievingdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Walgreen Company | 0363-3003 |
| Dg Health Arthritis Paindiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Dolgencorp Inc | 55910-926 |
| arthritis pain relievingdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Meijer Distribution Inc | 41250-674 |
| Diclofenac Sodium | Diclofenac sodium 10 mg/g | GelTopical | Padagis Israel Pharmaceuticals Ltd | 45802-953 |
| Foster And Thrive Arthritis Paindiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Strategic Sourcing Services LLC | 70677-1293 |
| DG health arthritis paindiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Dolgencorp Inc | 55910-424 |
| Good Sense Arthritis Paindiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | L. Perrigo Company | 0113-8175 |
| kirkland signature arthritis pain reliefdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Costco Wholesale Company | 63981-599 |
| Aspercreme Arthritisdiclofenac sodium | Diclofenac sodium .01 g/g | GelTopical | Chattem, Inc. | 41167-0573 |
| CareOne arthritis pain reliefdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | American Sales Company | 41520-788 |
| kirkland signature arthritis pain reliefdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Costco Wholesale Company | 63981-799 |
| good sense arthritis paindiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Proficient Rx LP | 71205-670 |
| diclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | NuCare Pharmaceuticals, Inc. | 68071-3671 |
| Arthritis Pain Relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | H E B | 59640-198 |
| basic care arthritis paindiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Amazon.com Services LLC | 72288-870 |
| Equate Arthritis Paindiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | WALMART INC. | 79903-391 |
| Motrin Arthritis Paindiclofenac sodium | Diclofenac sodium 9.3 mg/g | GelTopical | Kenvue Brands LLC | 50580-574 |
| Topcare Arthritis Pain Relieverdiclofenac sodium | Diclofenac sodium 10 mg/g | GelTopical | Topco Associates LLC | 76162-804 |
| Diclofenac Sodium | Diclofenac sodium 10 mg/g | GelTopical | Rite Aid Corporation | 11822-0870 |
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