Pain Reliever PM

Product NDC
55319-237
11-digit product format
553190237
Labeler code
55319
Product ID
55319-237_67121d7d-b05a-485b-9a10-e766b139e221
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine HCl
Dosage form
CAPSULE
Route
ORAL
Labeler
Family Dollar (FAMILY WELLNESS)
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-07-31
Marketing end
2022-12-30
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
500 mg/1; mg/1
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55319-237DDiscontinued by firm2026-10-05
excluded packagepackage55319-23755319-237-03DDiscontinued by firm2026-10-05
excluded packagepackage55319-23755319-237-12DDiscontinued 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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55319-237-12d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55319-237-03d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55319-237-12f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55319-237-03f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55319-237-122ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55319-237-032ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55319-237-12a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55319-237-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55319-237-12cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55319-237-03cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55319-237-12cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55319-237-03cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55319-237-12302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55319-237-03302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55319-237-12ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55319-237-03ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55319-237-120efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55319-237-030efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55319-237-12ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55319-237-03ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55319-237-12367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55319-237-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55319-237-12557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55319-237-03557ba5c1ecfa…9c80585c8c6e…

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 RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) CAPSULE [FAMILY DOLLAR (FAMILY WELLNESS)]1
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) CAPSULE [FAMILY DOLLAR (FAMILY WELLNESS)]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) CAPSULE [FAMILY DOLLAR (FAMILY WELLNESS)]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) CAPSULE [FAMILY DOLLAR (FAMILY WELLNESS)]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) CAPSULE [FAMILY DOLLAR (FAMILY WELLNESS)]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) CAPSULE [FAMILY DOLLAR (FAMILY WELLNESS)]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) CAPSULE [FAMILY DOLLAR (FAMILY WELLNESS)]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) CAPSULE [FAMILY DOLLAR (FAMILY WELLNESS)]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) CAPSULE [FAMILY DOLLAR (FAMILY WELLNESS)]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) CAPSULE [FAMILY DOLLAR (FAMILY WELLNESS)]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) CAPSULE [FAMILY DOLLAR (FAMILY WELLNESS)]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) CAPSULE [FAMILY DOLLAR (FAMILY WELLNESS)]1
GELATININACTIVE INGREDIENT2G86QN327LPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) CAPSULE [FAMILY DOLLAR (FAMILY WELLNESS)]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) CAPSULE [FAMILY DOLLAR (FAMILY WELLNESS)]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) CAPSULE [FAMILY DOLLAR (FAMILY WELLNESS)]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) CAPSULE [FAMILY DOLLAR (FAMILY WELLNESS)]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) CAPSULE [FAMILY DOLLAR (FAMILY WELLNESS)]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) CAPSULE [FAMILY DOLLAR (FAMILY WELLNESS)]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) CAPSULE [FAMILY DOLLAR (FAMILY WELLNESS)]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) CAPSULE [FAMILY DOLLAR (FAMILY WELLNESS)]1
TRIACETININACTIVE INGREDIENTXHX3C3X673PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) CAPSULE [FAMILY DOLLAR (FAMILY WELLNESS)]1
WATERINACTIVE INGREDIENT059QF0KO0RPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) CAPSULE [FAMILY DOLLAR (FAMILY WELLNESS)]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55319-237-03553190237031 BOTTLE in 1 BOX (55319-237-03) > 300 CAPSULE in 1 BOTTLE1 bottle2014-07-312022-12-30NoNoCurrent
55319-237-12553190237121 BOTTLE in 1 CARTON (55319-237-12) > 120 CAPSULE in 1 BOTTLE1 bottle2014-07-312022-12-30NoNoCurrent