FDA.reportPublic FDA data

Pain Relief PM

Product NDC
46122-456
11-digit product format
461220456
Labeler code
46122
Product ID
46122-456_01b64b70-2f19-49ea-a37d-6443d613c26b
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Aspirin, Diphenhydramine citrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amerisource Bergen
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2016-08-31
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; ASPIRIN; DIPHENHYDRAMINE CITRATE
Active strength
250 mg/1; mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct46122-456DDiscontinued by firm2026-10-05
excluded packagepackage46122-45646122-456-71DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46122-456-71Pain Relief PM50 in 1 BOTTLE, PLASTICTABLET, FILM COATED5012
46122-456-71Pain Relief PM1 in 1 CARTONTABLET, FILM COATED112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-456-71EA - Each46122-456038c1601-a599-4897-93a4-b2fedc48c7cb12019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-456PAIN RELIEF PM (ACETAMINOPHEN, ASPIRIN, DIPHENHYDRAMINE CITRATE) TABLET, FILM COATED [AMERISOURCE BERGEN]11Legacy NDC, 2 package rows20250119_f56c438a-0593-421f-8a7c-903d1874c8ea.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46122-456-71461220456711 BOTTLE, PLASTIC in 1 CARTON (46122-456-71) > 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2016-08-310000-00-00NoNoCurrent