Home NDC 0363-0543 Wal-Dryl
Product NDC 0363-0543
11-digit product format 003630543
Labeler code 0363
Product ID 0363-0543_163abe1a-9d4c-40d0-8f49-38f789688a82
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Walgreen Company
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2007-06-27
Marketing end 2023-12-14
Substance ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325 mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record 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 date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0363-0543-09 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0363-0543-09 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0363-0543-09 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0363-0543-09 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0363-0543-09 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0363-0543-09 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0363-0543-09 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0363-0543-09 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0363-0543-09 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 0363-0543-09 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0363-0543-09 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0363-0543-09 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D WAL-DRYL MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET [WALGREEN CO.] 4 DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 WAL-DRYL MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET [WALGREEN CO.] 4 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ WAL-DRYL MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET [WALGREEN CO.] 4 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D WAL-DRYL MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET [WALGREEN CO.] 4 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M WAL-DRYL MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET [WALGREEN CO.] 4 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV WAL-DRYL MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET [WALGREEN CO.] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U WAL-DRYL MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET [WALGREEN CO.] 4 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 WAL-DRYL MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET [WALGREEN CO.] 4 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD WAL-DRYL MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET [WALGREEN CO.] 4 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO WAL-DRYL MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET [WALGREEN CO.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 WAL-DRYL MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET [WALGREEN CO.] 4 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE WAL-DRYL MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET [WALGREEN CO.] 4 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A WAL-DRYL MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET [WALGREEN CO.] 4 POVIDONES INACTIVE INGREDIENT FZ989GH94E WAL-DRYL MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET [WALGREEN CO.] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 WAL-DRYL MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET [WALGREEN CO.] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ WAL-DRYL MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET [WALGREEN CO.] 4 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP WAL-DRYL MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET [WALGREEN CO.] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP WAL-DRYL MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET [WALGREEN CO.] 4 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 WAL-DRYL MAXIMUM STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) TABLET [WALGREEN CO.] 4
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0363-0543-09 00363054309 2 BLISTER PACK in 1 CARTON (0363-0543-09) > 10 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2007-06-27 2023-12-14 No No Current