healthy accents ibuprofen pm

Product NDC

55316-050

11-digit product format

553160050

Labeler code

55316

Product ID

55316-050_d57674a3-517a-4092-ac05-95a95da22116

Type

HUMAN OTC DRUG

Nonproprietary name

diphenhydramine citrate, ibuprofen

Dosage form

TABLET, COATED

Route

ORAL

Labeler

DZA Brands LLC

Application

ANDA079113

Marketing category

ANDA

Marketing start

2009-04-15

Marketing end

0000-00-00

Substance

DIPHENHYDRAMINE CITRATE; IBUPROFEN

Active strength

38 mg/1; mg/1

NDC exclude flag

No

Listing certified through

2019-12-31

Current FDA listing

Historical FDA.report record