PAIN RELIEVER PM

Product NDC
49348-233
11-digit product format
493480233
Labeler code
49348
Product ID
49348-233_36b9fa03-14d2-40ef-ac68-a25209b99fd4
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine HCl
Dosage form
TABLET, COATED
Route
ORAL
Labeler
McKesson (Sunmark)
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-03-08
Marketing end
2020-01-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49348-233DDiscontinued by firm2026-10-16
excluded packagepackage49348-23349348-233-09DDiscontinued by firm2026-10-16

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 packagepackage49348-233-09d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49348-233-09f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49348-233-092ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49348-233-09a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49348-233-09cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49348-233-09cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49348-233-09302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49348-233-09ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49348-233-090efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49348-233-09ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49348-233-09367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49348-233-09557ba5c1ecfa…9c80585c8c6e…

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
49348-233-09EA - Each49348-233085796db-1e69-47f4-955d-fd169916c87212014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [MCKESSON (SUNMARK)]2
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [MCKESSON (SUNMARK)]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [MCKESSON (SUNMARK)]2
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [MCKESSON (SUNMARK)]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [MCKESSON (SUNMARK)]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [MCKESSON (SUNMARK)]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [MCKESSON (SUNMARK)]2
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [MCKESSON (SUNMARK)]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [MCKESSON (SUNMARK)]2
GELATININACTIVE INGREDIENT2G86QN327LPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [MCKESSON (SUNMARK)]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [MCKESSON (SUNMARK)]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [MCKESSON (SUNMARK)]2
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [MCKESSON (SUNMARK)]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [MCKESSON (SUNMARK)]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [MCKESSON (SUNMARK)]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [MCKESSON (SUNMARK)]2
SODIUM STARCH GLYCOLATE TYPE A CORNINACTIVE INGREDIENTAG9B65PV6BPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [MCKESSON (SUNMARK)]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [MCKESSON (SUNMARK)]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [MCKESSON (SUNMARK)]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [MCKESSON (SUNMARK)]2
WATERINACTIVE INGREDIENT059QF0KO0RPAIN RELIEVER PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [MCKESSON (SUNMARK)]2