Wal-Nadol PM

Product NDC
0363-0235
Requested package NDC
0363-0235-08
11-digit product format
003630235
Labeler code
0363
Product ID
0363-0235_bcaa791a-b408-420e-b92d-ce7760783d0a
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen and Diphenhydramine HCl
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Walgreen Company
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
1994-05-15
Marketing end
0000-00-00
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
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0363-02350363-0235-08DDiscontinued 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 · 9 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…

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
0363-0235-12EA - Each0363-0235e9945d07-a1b2-44ec-bdba-fbdfb55f2e7012012-07-24
0363-0235-15EA - Each0363-0235c8c1b3b0-fd01-41a9-956e-74b353abe23712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DWAL-NADOL PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WALGREEN CO.]6
DIPHENHYDRAMINE HYDROCHLORIDEACTIVE INGREDIENTTC2D6JAD40WAL-NADOL PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WALGREEN CO.]6
ACETAMINOPHENACTIVE MOIETY362O9ITL9DWAL-NADOL PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WALGREEN CO.]6
DIPHENHYDRAMINEACTIVE MOIETY8GTS82S83MWAL-NADOL PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WALGREEN CO.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UWAL-NADOL PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WALGREEN CO.]6
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48WAL-NADOL PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WALGREEN CO.]6
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDWAL-NADOL PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WALGREEN CO.]6
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AWAL-NADOL PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WALGREEN CO.]6
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990WAL-NADOL PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WALGREEN CO.]6
POVIDONESINACTIVE INGREDIENTFZ989GH94EWAL-NADOL PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WALGREEN CO.]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4WAL-NADOL PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WALGREEN CO.]6
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APWAL-NADOL PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WALGREEN CO.]6
TALCINACTIVE INGREDIENT7SEV7J4R1UWAL-NADOL PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WALGREEN CO.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPWAL-NADOL PM (ACETAMINOPHEN AND DIPHENHYDRAMINE HCL) TABLET, FILM COATED [WALGREEN CO.]6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-0235-08003630235081 BOTTLE, PLASTIC in 1 CARTON (0363-0235-08) > 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1994-05-150000-00-00NoNoCurrent