Diphenhydramine / Naproxen Oral Tablet
- Brand(s)
- Aleve PM
- Category(s)
- otc
- SPL Type(s)
- Human OTC
- Master SPL
- Bayer Healthcare Llc (2014-09-12)
- Oldest Current Product
- 2014-09-09
- License(s)
- NDA
- RxNORM
- ORAL TABLET\DIPHENHYDRAMINE:NAPROXEN
- FDAOB
- ORAL\TABLET\DIPHENHYDRAMINE HYDROCHLORIDE: NAPROXEN SODIUM
- SPL Active
- ORAL\TABLET, FILM COATED\DIPHENHYDRAMINE HYDROCHLORIDE: NAPROXEN SODIUM
- SPL Moiety
- ORAL\TABLET, FILM COATED\DIPHENHYDRAMINE: NAPROXEN
product(s) by strength(s)
diphenhydramine hydrochloride 25 mg / naproxen sodium 220 mg oral tablet
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|
| 1 | 002801200 | Aleve PM | NDA | Bayer Healthcare Llc | 2014-09-09 | DIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUM | ORAL | TABLET, FILM COATED | NDA205352 | 82891458-ab0d-459a-8602-dcebd22c3010 |
| # | id | title | applicant | approved | exclusivity | approved drug |
|---|
| 1 | NDA205352 | ALEVE PM | BAYER HEALTHCARE CONSUMER CARE | 2014-01-17 | NEW COMBINATION [2017-01-17] | NDA205352_001 |
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
|---|
| 1 | NDA205352_001 | OTC | NAPROXEN SODIUM (220MG), DIPHENHYDRAMINE HYDROCHLORIDE (25MG) | ORAL | TABLET | True | 2014-01-17 | ALEVE PM |
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|
| 1 | 82891458-ab0d-459a-8602-dcebd22c3010 (view SPL) | Aleve PM | otc | Human OTC | Bayer Healthcare Llc | MANUFACTURE, PACK | 2014-09-12 | 1 | 002801200 |