Extra Strength Night Time Pain Medicine
- Product NDC
- 57896-324
- Requested package NDC
- 57896-324-05
- 11-digit product format
- 578960324
- Labeler code
- 57896
- Product ID
- 57896-324_e5450e02-b2f3-aaf9-e053-2995a90a4c30
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Diphenhydramine HCl
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Geri-Care Pharmaceutical Corp
- Application
- part341
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2022-06-01
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
- Active strength
- 500 mg/1; mg/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57896-324 | EXTRA STRENGTH NIGHT TIME PAIN MEDICINE (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [GERI-CARE PHARMACEUTICAL CORP] | 3 | Legacy NDC | 20241130_e5450e02-b2f2-aaf9-e053-2995a90a4c30.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 57896-324-05 | 57896032405 | 50 TABLET, COATED in 1 BOTTLE (57896-324-05) | 2022-06-01 | 0000-00-00 | No | No | Current |