NightTime Pain Reliever PM

Product NDC
0363-8590
11-digit product format
003638590
Labeler code
0363
Product ID
0363-8590_da58a7df-b10c-4339-b142-1d72c323150a
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, diphenhydramine hydrochloride
Dosage form
LIQUID
Route
ORAL
Labeler
WALGREEN CO.
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-06-08
Marketing end
2022-07-01
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
500 mg/15mL; mg/15mL
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 productproduct0363-8590DDiscontinued by firm2026-09-14
excluded packagepackage0363-85900363-8590-20DDiscontinued by firm2026-09-14

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 packagepackage0363-8590-20d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0363-8590-20f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0363-8590-202ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0363-8590-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0363-8590-20cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0363-8590-20cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0363-8590-20302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0363-8590-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0363-8590-200efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0363-8590-20ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0363-8590-20367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0363-8590-20557ba5c1ecfa…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 INGREDIENT362O9ITL9DNIGHTTIME PAIN RELIEVER PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [WALGREEN CO.]1
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40NIGHTTIME PAIN RELIEVER PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [WALGREEN CO.]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DNIGHTTIME PAIN RELIEVER PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [WALGREEN CO.]1
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MNIGHTTIME PAIN RELIEVER PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [WALGREEN CO.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLNIGHTTIME PAIN RELIEVER PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [WALGREEN CO.]1
BERRYINACTIVE INGREDIENTFV3431923ZNIGHTTIME PAIN RELIEVER PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [WALGREEN CO.]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311NIGHTTIME PAIN RELIEVER PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [WALGREEN CO.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNIGHTTIME PAIN RELIEVER PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [WALGREEN CO.]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SNIGHTTIME PAIN RELIEVER PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [WALGREEN CO.]1
HIGH FRUCTOSE CORN SYRUPINACTIVE INGREDIENTXY6UN3QB6SNIGHTTIME PAIN RELIEVER PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [WALGREEN CO.]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3ANIGHTTIME PAIN RELIEVER PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [WALGREEN CO.]1
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2BNIGHTTIME PAIN RELIEVER PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [WALGREEN CO.]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQNIGHTTIME PAIN RELIEVER PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [WALGREEN CO.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NIGHTTIME PAIN RELIEVER PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [WALGREEN CO.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUNIGHTTIME PAIN RELIEVER PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [WALGREEN CO.]1
SORBITOLINACTIVE INGREDIENT506T60A25RNIGHTTIME PAIN RELIEVER PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [WALGREEN CO.]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4NIGHTTIME PAIN RELIEVER PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [WALGREEN CO.]1
WATERINACTIVE INGREDIENT059QF0KO0RNIGHTTIME PAIN RELIEVER PM (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [WALGREEN CO.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-8590-20003638590201 BOTTLE in 1 CARTON (0363-8590-20) > 237 mL in 1 BOTTLE1 bottle2015-06-082022-07-01NoNoCurrent