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_13d39e35-564f-4aa5-94e0-cdced58aa01a
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
SPRAY
Route
TOPICAL
Labeler
QUANZHOU AIWINA HYGIENE PRODUCTS CO.,LTD
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-03-18
Substance
BENZALKONIUM CHLORIDE
Active strength
.13 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 FDA2026-08-03

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…

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]2Current NDC, Legacy 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