Extra Strength Acetaminophen PM

Product NDC
62011-0024
11-digit product format
620110024
Labeler code
62011
Product ID
62011-0024_ff40259c-4634-4c18-94c6-be365b37b960
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
McKesson
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-04-09
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
500 mg/1; mg/1
NDC exclude flag
E
Listing certified through
2018-12-31
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 productproduct62011-0024DDiscontinued by firm2026-10-15
excluded packagepackage62011-002462011-0024-1DDiscontinued by firm2026-10-15

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 packagepackage62011-0024-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage62011-0024-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage62011-0024-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage62011-0024-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage62011-0024-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage62011-0024-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage62011-0024-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage62011-0024-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage62011-0024-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage62011-0024-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage62011-0024-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage62011-0024-1557ba5c1ecfa…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
62011-0024-1EA - Each62011-0024810fd797-181a-43bc-bc6a-a77af1e69b5412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DEXTRA STRENGTH ACETAMINOPHEN PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCKESSON]1
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40EXTRA STRENGTH ACETAMINOPHEN PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCKESSON]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DEXTRA STRENGTH ACETAMINOPHEN PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCKESSON]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MEXTRA STRENGTH ACETAMINOPHEN PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCKESSON]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933EXTRA STRENGTH ACETAMINOPHEN PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCKESSON]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UEXTRA STRENGTH ACETAMINOPHEN PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCKESSON]1
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KEXTRA STRENGTH ACETAMINOPHEN PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCKESSON]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDEXTRA STRENGTH ACETAMINOPHEN PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCKESSON]1
GELATININACTIVE INGREDIENT2G86QN327LEXTRA STRENGTH ACETAMINOPHEN PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCKESSON]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXEXTRA STRENGTH ACETAMINOPHEN PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCKESSON]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOEXTRA STRENGTH ACETAMINOPHEN PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCKESSON]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DEXTRA STRENGTH ACETAMINOPHEN PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCKESSON]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AEXTRA STRENGTH ACETAMINOPHEN PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCKESSON]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EEXTRA STRENGTH ACETAMINOPHEN PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCKESSON]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4EXTRA STRENGTH ACETAMINOPHEN PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCKESSON]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJEXTRA STRENGTH ACETAMINOPHEN PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCKESSON]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APEXTRA STRENGTH ACETAMINOPHEN PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCKESSON]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEXTRA STRENGTH ACETAMINOPHEN PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCKESSON]1
WATERINACTIVE INGREDIENT059QF0KO0REXTRA STRENGTH ACETAMINOPHEN PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [MCKESSON]1