Pain Relief PM

Product NDC
63941-556
Requested package NDC
63941-556-10
11-digit product format
639410556
Labeler code
63941
Product ID
63941-556_d9908ba9-e0f8-4035-a0d6-896ab83afb54
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen and Diphenhydramine HCl
Dosage form
TABLET
Route
ORAL
Labeler
Valu Merchandisers Company
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2007-12-17
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 packagepackage63941-55663941-556-10DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63941-55663941-556-10DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63941-55663941-556-10DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [VALUE MERCHANDISERS COMPANY, INC.]3
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [VALUE MERCHANDISERS COMPANY, INC.]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [VALUE MERCHANDISERS COMPANY, INC.]3
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [VALUE MERCHANDISERS COMPANY, INC.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [VALUE MERCHANDISERS COMPANY, INC.]3
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [VALUE MERCHANDISERS COMPANY, INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [VALUE MERCHANDISERS COMPANY, INC.]3
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [VALUE MERCHANDISERS COMPANY, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [VALUE MERCHANDISERS COMPANY, INC.]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [VALUE MERCHANDISERS COMPANY, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [VALUE MERCHANDISERS COMPANY, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [VALUE MERCHANDISERS COMPANY, INC.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [VALUE MERCHANDISERS COMPANY, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET [VALUE MERCHANDISERS COMPANY, INC.]3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63941-556-10639410556101 BOTTLE, PLASTIC in 1 CARTON (63941-556-10) > 40 TABLET in 1 BOTTLE, PLASTIC2007-12-170000-00-00NoNoCurrent