MOTRIN ARTHRITIS PAIN
- Product NDC
- 50580-574
- 11-digit product format
- 505800574
- Labeler code
- 50580
- Product ID
- 50580-574_21aceda5-2c35-23df-e063-6394a90acb09
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diclofenac sodium
- Dosage form
- GEL
- Route
- TOPICAL
- Labeler
- Kenvue Brands LLC
- Application
- ANDA211253
- Marketing category
- ANDA
- Marketing start
- 2022-06-20
- Substance
- DICLOFENAC SODIUM
- Active strength
- 9.3 mg/g
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- MOTRIN ARTHRITIS PAIN
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DICLOFENAC SODIUM | 9.3 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | QTG126297Q |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50580-574-01 | MOTRIN ARTHRITIS PAIN | 50 g in 1 TUBE | GEL | 50 | | 10 |
| 50580-574-01 | MOTRIN ARTHRITIS PAIN | 1 in 1 CARTON | GEL | 1 | | 10 |
| 50580-574-02 | MOTRIN ARTHRITIS PAIN | 1 in 1 CARTON | GEL | 1 | | 10 |
| 50580-574-02 | MOTRIN ARTHRITIS PAIN | 100 g in 1 TUBE | GEL | 100 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50580-574 | MOTRIN ARTHRITIS PAIN (DICLOFENAC SODIUM) GEL [KENVUE BRANDS LLC] | 10 | Current NDC, Legacy NDC, 4 package rows | 20241109_db5b4288-13ec-826b-e053-2995a90a275e.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50580-574-01 | 50580057401 | 1 TUBE in 1 CARTON (50580-574-01) / 50 g in 1 TUBE | 1 tube | 2022-06-20 | 0000-00-00 | No | No | Current |
| 50580-574-02 | 50580057402 | 1 TUBE in 1 CARTON (50580-574-02) / 100 g in 1 TUBE | 1 tube | 2022-06-20 | 0000-00-00 | No | No | Current |