Home NDC 69721-001 Somnapure
Product NDC 69721-001
11-digit product format 697210001
Labeler code 69721
Product ID 69721-001_07dcc7b4-c6c4-4d66-b84e-5eaf408acc84
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine Hydrochloride
Dosage form TABLET, COATED
Route ORAL
Labeler NutraClick, LLC
Application part338
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-04-09
Marketing end 0000-00-00
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 50 mg/1
NDC exclude flag No
Listing certified through 2019-12-31
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 · 42 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 69721-001-30 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 69721-001-30 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 69721-001-30 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 69721-001-30 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 69721-001-30 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 69721-001-30 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 69721-001-30 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 69721-001-30 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 69721-001-30 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 69721-001-30 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 69721-001-30 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 69721-001-30 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 69721-001-30 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 69721-001-30 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 69721-001-30 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 69721-001-30 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 69721-001-30 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 69721-001-30 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 69721-001-30 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 69721-001-30 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 69721-001-30 9bebd1f3094a…5416666fcb17…
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 69721-001-30 SomnapureClinical Strength 30 in 1 BOTTLE TABLET, COATED 30 1 69721-001-30 SomnapureClinical Strength 1 in 1 BOX TABLET, COATED 1 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 SOMNAPURE CLINICAL STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [NUTRACLICK, LLC] 1 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M SOMNAPURE CLINICAL STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [NUTRACLICK, LLC] 1 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J SOMNAPURE CLINICAL STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [NUTRACLICK, LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SOMNAPURE CLINICAL STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [NUTRACLICK, LLC] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 SOMNAPURE CLINICAL STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [NUTRACLICK, LLC] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD SOMNAPURE CLINICAL STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [NUTRACLICK, LLC] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK SOMNAPURE CLINICAL STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [NUTRACLICK, LLC] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO SOMNAPURE CLINICAL STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [NUTRACLICK, LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SOMNAPURE CLINICAL STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [NUTRACLICK, LLC] 1 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D SOMNAPURE CLINICAL STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [NUTRACLICK, LLC] 1 medium-chain triglycerides INACTIVE INGREDIENT C9H2L21V7U SOMNAPURE CLINICAL STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [NUTRACLICK, LLC] 1 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE SOMNAPURE CLINICAL STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [NUTRACLICK, LLC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 SOMNAPURE CLINICAL STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [NUTRACLICK, LLC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ SOMNAPURE CLINICAL STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [NUTRACLICK, LLC] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP SOMNAPURE CLINICAL STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [NUTRACLICK, LLC] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U SOMNAPURE CLINICAL STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [NUTRACLICK, LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SOMNAPURE CLINICAL STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [NUTRACLICK, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69721-001 SOMNAPURE CLINICAL STRENGTH (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [NUTRACLICK, LLC] 1 Legacy NDC, 2 package rows 20150416_cddfdbdd-e6d0-49ef-88e7-b5827c665140.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 69721-001-30 69721000130 30 in 1 BOTTLE Historical