Home NDC 20146-4000 Breaze
Product NDC 20146-4000
11-digit product format 201464000
Labeler code 20146
Product ID 20146-4000_9dcf7331-9e1e-45e2-96d4-24999bf99e0b
Type HUMAN OTC DRUG
Nonproprietary name Oxymetazoline hydrochloride
Dosage form SPRAY
Route NASAL
Labeler Samson Pharmaceuticals, Inc.
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-01-01
Marketing end 0000-00-00
Substance OXYMETAZOLINE HYDROCHLORIDE
Active strength 1 mg/mL
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 · 30 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 20146-4000-2 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 20146-4000-2 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 20146-4000-2 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 20146-4000-2 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 20146-4000-2 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 20146-4000-2 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 20146-4000-2 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 20146-4000-2 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 20146-4000-2 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 20146-4000-2 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 20146-4000-2 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 20146-4000-2 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 20146-4000-2 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 20146-4000-2 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 20146-4000-2 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…
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 20146-4000-2 Breaze Nasal Moisturizing 1 in 1 CARTON SPRAY 1 2 20146-4000-2 Breaze Nasal Moisturizing 30 mL in 1 BOTTLE, SPRAY SPRAY 30 2
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Oxymetazoline hydrochloride ACTIVE INGREDIENT K89MJ0S5VY BREAZE NASAL MOISTURIZING (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [SAMSON PHARMACEUTICALS, INC.] 1 Oxymetazoline ACTIVE MOIETY 8VLN5B44ZY BREAZE NASAL MOISTURIZING (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [SAMSON PHARMACEUTICALS, INC.] 1 Benzalkonium Chloride INACTIVE INGREDIENT F5UM2KM3W7 BREAZE NASAL MOISTURIZING (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [SAMSON PHARMACEUTICALS, INC.] 1 Edetate Disodium INACTIVE INGREDIENT 7FLD91C86K BREAZE NASAL MOISTURIZING (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [SAMSON PHARMACEUTICALS, INC.] 1 Glycerin INACTIVE INGREDIENT PDC6A3C0OX BREAZE NASAL MOISTURIZING (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [SAMSON PHARMACEUTICALS, INC.] 1 Polyethylene Glycols INACTIVE INGREDIENT 3WJQ0SDW1A BREAZE NASAL MOISTURIZING (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [SAMSON PHARMACEUTICALS, INC.] 1 Povidones INACTIVE INGREDIENT FZ989GH94E BREAZE NASAL MOISTURIZING (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [SAMSON PHARMACEUTICALS, INC.] 1 Propylene Glycol INACTIVE INGREDIENT 6DC9Q167V3 BREAZE NASAL MOISTURIZING (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [SAMSON PHARMACEUTICALS, INC.] 1 Sodium Phosphate, Dibasic, Anhydrous INACTIVE INGREDIENT 22ADO53M6F BREAZE NASAL MOISTURIZING (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [SAMSON PHARMACEUTICALS, INC.] 1 Sodium Phosphate, Monobasic, Anhydrous INACTIVE INGREDIENT KH7I04HPUU BREAZE NASAL MOISTURIZING (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [SAMSON PHARMACEUTICALS, INC.] 1 Water INACTIVE INGREDIENT 059QF0KO0R BREAZE NASAL MOISTURIZING (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [SAMSON PHARMACEUTICALS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 20146-4000 BREAZE NASAL MOISTURIZING (OXYMETAZOLINE HYDROCHLORIDE) SPRAY [SAMSON PHARMACEUTICALS, INC.] 2 Legacy NDC, 2 package rows 20230718_9a165a12-43d3-4e14-a7ba-bfce579430d6.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 20146-4000-2 20146400002 1 in 1 CARTON Historical