Pain Relief PM

Product NDC
33992-0447
11-digit product format
339920447
Labeler code
33992
Product ID
33992-0447_a0ee3412-bbee-400f-ba85-a2612e86c80d
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine HCl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
ASSURED / DOLLAR TREE (Greenbrier International, Inc.)
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-11-30
Marketing end
2022-12-30
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
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct33992-0447DDiscontinued by firm2026-08-11
excluded packagepackage33992-044733992-0447-2DDiscontinued by firm2026-08-11

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 · 24 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 packagepackage33992-0447-2d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage33992-0447-2f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage33992-0447-22ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage33992-0447-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage33992-0447-2cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage33992-0447-2cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage33992-0447-2302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage33992-0447-2ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage33992-0447-20efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage33992-0447-2ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage33992-0447-2367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage33992-0447-2557ba5c1ecfa…9c80585c8c6e…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [ASSURED / DOLLAR TREE (GREENBRIER INTERNATIONAL, INC.)]1
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [ASSURED / DOLLAR TREE (GREENBRIER INTERNATIONAL, INC.)]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [ASSURED / DOLLAR TREE (GREENBRIER INTERNATIONAL, INC.)]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [ASSURED / DOLLAR TREE (GREENBRIER INTERNATIONAL, INC.)]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [ASSURED / DOLLAR TREE (GREENBRIER INTERNATIONAL, INC.)]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [ASSURED / DOLLAR TREE (GREENBRIER INTERNATIONAL, INC.)]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [ASSURED / DOLLAR TREE (GREENBRIER INTERNATIONAL, INC.)]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [ASSURED / DOLLAR TREE (GREENBRIER INTERNATIONAL, INC.)]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [ASSURED / DOLLAR TREE (GREENBRIER INTERNATIONAL, INC.)]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [ASSURED / DOLLAR TREE (GREENBRIER INTERNATIONAL, INC.)]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [ASSURED / DOLLAR TREE (GREENBRIER INTERNATIONAL, INC.)]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [ASSURED / DOLLAR TREE (GREENBRIER INTERNATIONAL, INC.)]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [ASSURED / DOLLAR TREE (GREENBRIER INTERNATIONAL, INC.)]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [ASSURED / DOLLAR TREE (GREENBRIER INTERNATIONAL, INC.)]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [ASSURED / DOLLAR TREE (GREENBRIER INTERNATIONAL, INC.)]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [ASSURED / DOLLAR TREE (GREENBRIER INTERNATIONAL, INC.)]1
SODIUM STARCH GLYCOLATE TYPE A CORNINACTIVE INGREDIENTAG9B65PV6BPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [ASSURED / DOLLAR TREE (GREENBRIER INTERNATIONAL, INC.)]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [ASSURED / DOLLAR TREE (GREENBRIER INTERNATIONAL, INC.)]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [ASSURED / DOLLAR TREE (GREENBRIER INTERNATIONAL, INC.)]1
TALCINACTIVE INGREDIENT7SEV7J4R1UPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [ASSURED / DOLLAR TREE (GREENBRIER INTERNATIONAL, INC.)]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [ASSURED / DOLLAR TREE (GREENBRIER INTERNATIONAL, INC.)]1
WATERINACTIVE INGREDIENT059QF0KO0RPAIN RELIEF PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [ASSURED / DOLLAR TREE (GREENBRIER INTERNATIONAL, INC.)]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
33992-0447-2339920447021 BOTTLE, PLASTIC in 1 BOX (33992-0447-2) > 24 TABLET, COATED in 1 BOTTLE, PLASTIC2014-11-302022-12-30NoNoCurrent