Aleve
- Product NDC
- 0280-0112
- 11-digit product format
- 002800112
- Labeler code
- 0280
- Product ID
- 0280-0112_31baf777-c806-21ea-e063-6394a90abbd8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- NAPROXEN SODIUM
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bayer HealthCare LLC.
- Application
- NDA020204
- Marketing category
- NDA
- Marketing start
- 2023-04-04
- Substance
- NAPROXEN SODIUM
- Active strength
- 220 mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], 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
- Aleve
- Brand name suffix
- Headache Pain
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| NAPROXEN SODIUM | 220 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 9TN87S3A3C |
| Rxcui | 849574, 849728 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fef6ad89-235f-4274-ba49-a8e53642473e | Product name | 2 | 20250225 |
| 87fed3e6-8fba-48ef-96b0-3a7fb54b96ff | Product name | 3 | 20230306 |
| a62a50ac-1535-4461-9768-8ae703e2e9fb | Product name | 1 | 20210525 |
| b5fdaaec-7251-4da6-9cb2-4e9e76939ec8 | Product name | 1 | 20200623 |
| e76dbbc1-775d-722c-08ff-ed45e8a80def | Product name | 3 | 20181002 |
| 6f4f4521-fd56-1ae6-888b-3b021bd75c7c | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
| bc07ef78-e82d-0c19-31f4-31f263780582 | Product name | 1 | 20140508 |
| ce67e27d-1d21-5465-4409-b0662dd99d4d | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0280-0112-01 | AleveHeadache Pain | 1 in 1 CARTON | TABLET | 1 | 1 | |
| 0280-0112-01 | AleveHeadache Pain | 175 in 1 BOTTLE | TABLET | 175 | 1 | |
| 0280-0112-02 | AleveHeadache Pain | 24 in 1 BOTTLE | TABLET | 24 | 1 | |
| 0280-0112-02 | AleveHeadache Pain | 1 in 1 CARTON | TABLET | 1 | 1 | |
| 0280-0112-03 | AleveHeadache Pain | 1 in 1 CARTON | TABLET | 1 | 1 | |
| 0280-0112-03 | AleveHeadache Pain | 50 in 1 BOTTLE | TABLET | 50 | 1 | |
| 0280-0112-04 | AleveHeadache Pain | 90 in 1 BOTTLE | TABLET | 90 | 1 | |
| 0280-0112-04 | AleveHeadache Pain | 1 in 1 CARTON | TABLET | 1 | 1 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 849728 | Aleve 220 MG Oral Tablet | PSN | 31baf777-c805-21ea-e063-6394a90abbd8 | 1 |
| 849574 | naproxen sodium 220 MG Oral Tablet | PSN | 31baf777-c805-21ea-e063-6394a90abbd8 | 1 |
| 849728 | naproxen sodium 220 MG Oral Tablet [Aleve] | SBD | 31baf777-c805-21ea-e063-6394a90abbd8 | 1 |
| 849574 | naproxen sodium 220 MG Oral Tablet | SCD | 31baf777-c805-21ea-e063-6394a90abbd8 | 1 |
| 849728 | Aleve 220 MG Oral Tablet | SY | 31baf777-c805-21ea-e063-6394a90abbd8 | 1 |
| 849574 | naproxen sodium 220 MG (as naproxen 200 MG) Oral Tablet | SY | 31baf777-c805-21ea-e063-6394a90abbd8 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0280-0112-01 | 00280011201 | 1 BOTTLE in 1 CARTON (0280-0112-01) / 175 TABLET in 1 BOTTLE | 1 bottle | 2024-03-25 | No | No | Historical |
| 0280-0112-02 | 00280011202 | 1 BOTTLE in 1 CARTON (0280-0112-02) / 24 TABLET in 1 BOTTLE | 1 bottle | 2024-03-25 | No | No | Historical |
| 0280-0112-03 | 00280011203 | 1 BOTTLE in 1 CARTON (0280-0112-03) / 50 TABLET in 1 BOTTLE | 1 bottle | 2024-03-25 | No | No | Historical |
| 0280-0112-04 | 00280011204 | 1 BOTTLE in 1 CARTON (0280-0112-04) / 90 TABLET in 1 BOTTLE | 1 bottle | 2024-03-25 | No | No | Historical |