QCare Petite Size Oral Cleansing and Suctioning System

Product NDC
53462-714
11-digit product format
534620714
Labeler code
53462
Product ID
53462-714_7fad186f-f7f7-6c35-e053-2a91aa0a873e
Type
HUMAN OTC DRUG
Nonproprietary name
CETYLPYRIDINIUM CHLORIDE
Dosage form
KIT
Labeler
Sage Products, LLC
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-04-02
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53462-714IInactivated by FDA2026-10-12
excluded packagepackage53462-71453462-714-60IInactivated by FDA2026-10-12

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 · 38 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 packagepackage53462-714-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53462-714-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53462-714-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53462-714-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53462-714-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53462-714-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53462-714-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53462-714-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53462-714-600efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53462-714-60ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53462-714-60367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53462-714-60557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage53462-714-608af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage53462-714-60834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage53462-714-601332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage53462-714-60fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage53462-714-6086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage53462-714-60bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage53462-714-608dfbde2a14a4…c9ff85d89658…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53462-714-602021-01-29C16284748780-1ba0f9c33-2e59-a910-e053-dadaa90a0b85QCare Petite Size Oral Cleansing and Suctioning System

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53462-175-60QCare Petite Size Oral Cleansing and Suctioning System7 mL in 1 PACKETMOUTHWASH42 mL in 60.5 mg in 1mL4
53462-714-60QCare Petite Size Oral Cleansing and Suctioning System1 in 1 KITKIT14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CETYLPYRIDINIUM CHLORIDEACTIVE INGREDIENTD9OM4SK49PQCARE PETITE SIZE ORAL CLEANSING AND SUCTIONING SYSTEM (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]1
CETYLPYRIDINIUMACTIVE MOIETYCUB7JI0JV3QCARE PETITE SIZE ORAL CLEANSING AND SUCTIONING SYSTEM (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPQCARE PETITE SIZE ORAL CLEANSING AND SUCTIONING SYSTEM (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDQCARE PETITE SIZE ORAL CLEANSING AND SUCTIONING SYSTEM (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]1
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2BQCARE PETITE SIZE ORAL CLEANSING AND SUCTIONING SYSTEM (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHQCARE PETITE SIZE ORAL CLEANSING AND SUCTIONING SYSTEM (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HQCARE PETITE SIZE ORAL CLEANSING AND SUCTIONING SYSTEM (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4QCARE PETITE SIZE ORAL CLEANSING AND SUCTIONING SYSTEM (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]1
SORBITOLINACTIVE INGREDIENT506T60A25RQCARE PETITE SIZE ORAL CLEANSING AND SUCTIONING SYSTEM (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RQCARE PETITE SIZE ORAL CLEANSING AND SUCTIONING SYSTEM (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53462-714QCARE PETITE SIZE ORAL CLEANSING AND SUCTIONING SYSTEM (CETYLPYRIDINIUM CHLORIDE) KIT [SAGE PRODUCTS, LLC]4Legacy NDC, 2 package rows20190118_b08bc4f9-85db-b57c-5e1d-97e3383acf18.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1251617cetylpyridinium chloride 0.05 % MouthwashPSNb08bc4f9-85db-b57c-5e1d-97e3383acf184
1251617cetylpyridinium chloride 0.5 MG/ML MouthwashSCDb08bc4f9-85db-b57c-5e1d-97e3383acf184
1251617cetylpyridinium chloride 0.05 % MouthwashSYb08bc4f9-85db-b57c-5e1d-97e3383acf184

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
53462-175-60534620175607 mL in 1 PACKET7 mlHistorical
53462-714-60534620714601 in 1 KITHistorical