FDA.reportPublic FDA data

Snugell

Product NDC
80671-005
Requested package NDC
80671-005-33
11-digit product format
806710005
Labeler code
80671
Product ID
80671-005_bdeab71d-32f6-4d2f-a0c8-d5d07c65dc69
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
SPRAY
Route
TOPICAL
Labeler
QUANZHOU AIWINA HYGIENE PRODUCTS CO.,LTD
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2022-03-18
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
0 g/100mL
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage80671-00580671-005-33IInactivated by FDA2026-10-05

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 · 6 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
80671-005-332025-01-07C16284748780-10191ceaa-649a-198a-e063-dbdaa90aec3esnugell ​® ​ ​ ​ CPAP MASK SPRAY
80671-005-332023-07-28C16284748780-10191ceaa-649a-198a-e063-dbdaa90aec3esnugell ​® ​ ​ ​ CPAP MASK SPRAY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80671-005-33Snugell473 mL in 1 BOTTLESPRAY4732

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80671-005SNUGELL (BENZALKONIUM CHLORIDE) SPRAY [QUANZHOU AIWINA HYGIENE PRODUCTS CO.,LTD]2Legacy NDC, 1 package rows20250108_b4f6852c-5044-4ab9-8395-4ce8bf1d0a70.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1039012benzalkonium chloride 0.13 % Topical SprayPSNb4f6852c-5044-4ab9-8395-4ce8bf1d0a702
1039012benzalkonium chloride 1.3 MG/ML Topical SpraySCDb4f6852c-5044-4ab9-8395-4ce8bf1d0a702
1039012benzalkonium chloride 0.13 % Topical SpraySYb4f6852c-5044-4ab9-8395-4ce8bf1d0a702

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80671-005-3380671000533473 mL in 1 BOTTLE (80671-005-33) 473 ml2022-03-180000-00-00NoNoCurrent