Home NDC 40002-004 Diphenhydramine
Product NDC 40002-004
11-digit product format 400020004
Labeler code 40002
Product ID 40002-004_3846ecd5-9298-40e6-84d4-e1ef8815b86e
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine HCl, Zinc Acetate
Dosage form CREAM
Route TOPICAL
Labeler NexMed (USA), Inc.
Application part348
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2011-08-29
Marketing end 0000-00-00
Substance DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Active strength 2 g/100g; g/100g
NDC exclude flag E
Listing certified through 2017-12-31
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 · 44 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 40002-004-03 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 40002-004-03 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 40002-004-03 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 40002-004-03 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 40002-004-03 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 40002-004-03 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 40002-004-03 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 40002-004-03 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 40002-004-03 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 40002-004-03 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 40002-004-03 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 40002-004-03 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 40002-004-03 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 40002-004-03 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 40002-004-03 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 40002-004-03 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 40002-004-03 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 40002-004-03 bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 40002-004-03 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 40002-004-03 e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 40002-004-03 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 40002-004-03 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 40002-004-02 Diphenhydramine D 28 g in 1 TUBE CREAM 28 1 40002-004-03 Diphenhydramine D 1 in 1 CARTON CREAM 1 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 DIPHENHYDRAMINE (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [NEXMED (USA), INC.] 1 ZINC ACETATE ACTIVE INGREDIENT FM5526K07A DIPHENHYDRAMINE (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [NEXMED (USA), INC.] 1 Diphenhydramine ACTIVE MOIETY 8GTS82S83M DIPHENHYDRAMINE (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [NEXMED (USA), INC.] 1 ZINC ACTIVE MOIETY J41CSQ7QDS DIPHENHYDRAMINE (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [NEXMED (USA), INC.] 1 CETYL ALCOHOL INACTIVE INGREDIENT 936JST6JCN DIPHENHYDRAMINE (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [NEXMED (USA), INC.] 1 DIAZOLIDINYL UREA INACTIVE INGREDIENT H5RIZ3MPW4 DIPHENHYDRAMINE (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [NEXMED (USA), INC.] 1 Dodecyl-2-N,N-Dimethylaminopropionate Hydrochloride INACTIVE INGREDIENT 18F5YMF989 DIPHENHYDRAMINE (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [NEXMED (USA), INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T DIPHENHYDRAMINE (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [NEXMED (USA), INC.] 1 PEG-2 STEARATE INACTIVE INGREDIENT 94YQ11Y95F DIPHENHYDRAMINE (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [NEXMED (USA), INC.] 1 PEG-20 STEARATE INACTIVE INGREDIENT NBX892EA57 DIPHENHYDRAMINE (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [NEXMED (USA), INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DIPHENHYDRAMINE (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [NEXMED (USA), INC.] 1 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH DIPHENHYDRAMINE (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [NEXMED (USA), INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R DIPHENHYDRAMINE (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [NEXMED (USA), INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 40002-004 DIPHENHYDRAMINE (DIPHENHYDRAMINE HCL, ZINC ACETATE) CREAM [NEXMED (USA), INC.] 1 Legacy NDC, 2 package rows 20110830_602c2a3a-557c-452d-a7ed-4e0e9c3b742f.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 40002-004-02 40002000402 28 g in 1 TUBE 28 g Historical 40002-004-03 40002000403 1 in 1 CARTON Historical