Home NDC 64092-012 Rest Simply
Product NDC 64092-012
11-digit product format 640920012
Labeler code 64092
Product ID 64092-012_15a46d0f-7693-40df-8621-dd64336083f4
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.
Application part338
Marketing category OTC MONOGRAPH FINAL
Marketing start 2000-06-10
Marketing end 0000-00-00
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 25 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 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 · 22 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 64092-012-24 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 64092-012-24 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 64092-012-24 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 64092-012-24 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 64092-012-24 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 64092-012-24 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 64092-012-24 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 64092-012-24 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 64092-012-24 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 64092-012-24 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 64092-012-24 367a005e9d99…383a685ebd0f…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 REST SIMPLY (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.] 2 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M REST SIMPLY (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.] 2 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J REST SIMPLY (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U REST SIMPLY (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD REST SIMPLY (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 REST SIMPLY (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A REST SIMPLY (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.] 2 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 REST SIMPLY (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP REST SIMPLY (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U REST SIMPLY (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP REST SIMPLY (DIPHENHYDRAMINE HCL) TABLET, FILM COATED [GREAT LAKES WHOLESALE, MARKETING, & SALES, INC.] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 64092-012-24 64092001224 2 BLISTER PACK in 1 CARTON (64092-012-24) > 12 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2000-06-10 0000-00-00 No No Current