mouth fresh

Product NDC
51414-500
11-digit product format
514140500
Labeler code
51414
Product ID
51414-500_b4b2224e-107c-4ede-9f59-944acd52e97f
Type
HUMAN OTC DRUG
Nonproprietary name
Cetylpyridinium Chloride
Dosage form
SPRAY
Route
TOPICAL
Labeler
Yuyao Jessie Commodity Co.,Ltd.
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-09-12
Marketing end
0000-00-00
Substance
CETYLPYRIDINIUM CHLORIDE
Active strength
0 mL/100mL
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 18 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51414-500IInactivated by FDA2026-10-20
excluded packagepackage51414-50051414-500-01IInactivated by FDA2026-10-20
excluded packagepackage51414-50051414-500-02IInactivated by FDA2026-10-20
excluded packagepackage51414-50051414-500-03IInactivated by FDA2026-10-20
excluded packagepackage51414-50051414-500-04IInactivated by FDA2026-10-20
excluded packagepackage51414-50051414-500-05IInactivated by FDA2026-10-20
excluded packagepackage51414-50051414-500-06IInactivated by FDA2026-10-20
excluded packagepackage51414-50051414-500-07IInactivated by FDA2026-10-20
excluded packagepackage51414-50051414-500-08IInactivated by FDA2026-10-20
excluded packagepackage51414-50051414-500-09IInactivated by FDA2026-10-20
excluded packagepackage51414-50051414-500-10IInactivated by FDA2026-10-20
excluded packagepackage51414-50051414-500-11IInactivated by FDA2026-10-20
excluded packagepackage51414-50051414-500-12IInactivated by FDA2026-10-20
excluded packagepackage51414-50051414-500-13IInactivated by FDA2026-10-20
excluded packagepackage51414-50051414-500-14IInactivated by FDA2026-10-20
excluded packagepackage51414-50051414-500-15IInactivated by FDA2026-10-20
excluded packagepackage51414-50051414-500-16IInactivated by FDA2026-10-20
excluded packagepackage51414-50051414-500-17IInactivated by FDA2026-10-20

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 7 · 378 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51414-500-12d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51414-500-13d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51414-500-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51414-500-04d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51414-500-09d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51414-500-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51414-500-15d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51414-500-16d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51414-500-08d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51414-500-17d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51414-500-06d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51414-500-14d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51414-500-11d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51414-500-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51414-500-10d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51414-500-05d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51414-500-07d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51414-500-12f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51414-500-13f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51414-500-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51414-500-04f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51414-500-09f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51414-500-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51414-500-15f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51414-500-16f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51414-500-08f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51414-500-17f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51414-500-06f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51414-500-14f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51414-500-11f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51414-500-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51414-500-10f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51414-500-05f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51414-500-07f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51414-500-122ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51414-500-132ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51414-500-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51414-500-042ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51414-500-092ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51414-500-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51414-500-152ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51414-500-162ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51414-500-082ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51414-500-172ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51414-500-062ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51414-500-142ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51414-500-112ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51414-500-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51414-500-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51414-500-052ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51414-500-072ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51414-500-12a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51414-500-13a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51414-500-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51414-500-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51414-500-09a1b67e2a42f9…c4cf2c586c0d…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51414-500-01mouth fresh2 mL in 1 PACKAGESPRAY21
51414-500-02mouth fresh3 mL in 1 PACKAGESPRAY31
51414-500-03mouth fresh4 mL in 1 PACKAGESPRAY41
51414-500-04mouth fresh5 mL in 1 PACKAGESPRAY51
51414-500-05mouth fresh6 mL in 1 PACKAGESPRAY61
51414-500-06mouth fresh7 mL in 1 PACKAGESPRAY71
51414-500-07mouth fresh8 mL in 1 PACKAGESPRAY81
51414-500-08mouth fresh9 mL in 1 PACKAGESPRAY91
51414-500-09mouth fresh10 mL in 1 PACKAGESPRAY101
51414-500-10mouth fresh15 mL in 1 PACKAGESPRAY151
51414-500-11mouth fresh20 mL in 1 PACKAGESPRAY201
51414-500-12mouth fresh25 mL in 1 PACKAGESPRAY251
51414-500-13mouth fresh30 mL in 1 PACKAGESPRAY301
51414-500-14mouth fresh35 mL in 1 PACKAGESPRAY351
51414-500-15mouth fresh40 mL in 1 PACKAGESPRAY401
51414-500-16mouth fresh45 mL in 1 PACKAGESPRAY451
51414-500-17mouth fresh50 mL in 1 PACKAGESPRAY501

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETYLPYRIDINIUM CHLORIDEACTIVE INGREDIENTD9OM4SK49PMOUTH FRESH (CETYLPYRIDINIUM CHLORIDE) SPRAY [YUYAO JESSIE COMMODITY CO.,LTD.]1
CETYLPYRIDINIUMACTIVE MOIETYCUB7JI0JV3MOUTH FRESH (CETYLPYRIDINIUM CHLORIDE) SPRAY [YUYAO JESSIE COMMODITY CO.,LTD.]1
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0MOUTH FRESH (CETYLPYRIDINIUM CHLORIDE) SPRAY [YUYAO JESSIE COMMODITY CO.,LTD.]1
CHLOROMETHYL METHYL ETHERINACTIVE INGREDIENT334G5B96VGMOUTH FRESH (CETYLPYRIDINIUM CHLORIDE) SPRAY [YUYAO JESSIE COMMODITY CO.,LTD.]1
CITRIC ACID ACETATEINACTIVE INGREDIENTDSO12WL7AUMOUTH FRESH (CETYLPYRIDINIUM CHLORIDE) SPRAY [YUYAO JESSIE COMMODITY CO.,LTD.]1
DISODIUM COCOAMPHODIACETATEINACTIVE INGREDIENT18L9G3U51MMOUTH FRESH (CETYLPYRIDINIUM CHLORIDE) SPRAY [YUYAO JESSIE COMMODITY CO.,LTD.]1
DISODIUM EDTA-COPPERINACTIVE INGREDIENT6V475AX06UMOUTH FRESH (CETYLPYRIDINIUM CHLORIDE) SPRAY [YUYAO JESSIE COMMODITY CO.,LTD.]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHMOUTH FRESH (CETYLPYRIDINIUM CHLORIDE) SPRAY [YUYAO JESSIE COMMODITY CO.,LTD.]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4MOUTH FRESH (CETYLPYRIDINIUM CHLORIDE) SPRAY [YUYAO JESSIE COMMODITY CO.,LTD.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3MOUTH FRESH (CETYLPYRIDINIUM CHLORIDE) SPRAY [YUYAO JESSIE COMMODITY CO.,LTD.]1
QUATERNIUM-15INACTIVE INGREDIENTE40U03LEM0MOUTH FRESH (CETYLPYRIDINIUM CHLORIDE) SPRAY [YUYAO JESSIE COMMODITY CO.,LTD.]1
WATERINACTIVE INGREDIENT059QF0KO0RMOUTH FRESH (CETYLPYRIDINIUM CHLORIDE) SPRAY [YUYAO JESSIE COMMODITY CO.,LTD.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51414-500MOUTH FRESH (CETYLPYRIDINIUM CHLORIDE) SPRAY [YUYAO JESSIE COMMODITY CO.,LTD.]1Legacy NDC, 17 package rows20120925_a8892189-9f79-4831-b157-5e99544ab8a9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
51414-500-01514140500012 mL in 1 PACKAGE2 mlHistorical
51414-500-02514140500023 mL in 1 PACKAGE3 mlHistorical
51414-500-03514140500034 mL in 1 PACKAGE4 mlHistorical
51414-500-04514140500045 mL in 1 PACKAGE5 mlHistorical
51414-500-05514140500056 mL in 1 PACKAGE6 mlHistorical
51414-500-06514140500067 mL in 1 PACKAGE7 mlHistorical
51414-500-07514140500078 mL in 1 PACKAGE8 mlHistorical
51414-500-08514140500089 mL in 1 PACKAGE9 mlHistorical
51414-500-095141405000910 mL in 1 PACKAGE10 mlHistorical
51414-500-105141405001015 mL in 1 PACKAGE15 mlHistorical
51414-500-115141405001120 mL in 1 PACKAGE20 mlHistorical
51414-500-125141405001225 mL in 1 PACKAGE25 mlHistorical
51414-500-135141405001330 mL in 1 PACKAGE30 mlHistorical
51414-500-145141405001435 mL in 1 PACKAGE35 mlHistorical
51414-500-155141405001540 mL in 1 PACKAGE40 mlHistorical
51414-500-165141405001645 mL in 1 PACKAGE45 mlHistorical
51414-500-175141405001750 mL in 1 PACKAGE50 mlHistorical