Extra Strength Night Time Pain Relief

Product NDC
46122-707
Requested package NDC
46122-707-71
11-digit product format
461220707
Labeler code
46122
Product ID
46122-707_e5f93e73-9e1f-150a-e053-2995a90a2778
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine HCl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
AMERISOURCE BERGEN
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage46122-70746122-707-71DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-707-62EA - Each46122-70707299022-6199-46b0-8582-a5b98924147c12023-04-07
46122-707-71EA - Each46122-70790f23e10-79e3-45ce-ab2d-0a25bc9cc20512023-04-07
46122-707-78EA - Each46122-70764ea4001-60cd-496a-918d-a77cc7a1e93912023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-707EXTRA STRENGTH NIGHT TIME PAIN RELIEF (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [AMERISOURCE BERGEN]4Legacy NDC20241130_e5f93e73-9e1e-150a-e053-2995a90a2778.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46122-707-71461220707711 BOTTLE in 1 CARTON (46122-707-71) > 50 TABLET, COATED in 1 BOTTLE1 bottle2022-06-010000-00-00NoNoCurrent