Snugell

Product NDC
80671-005
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

Additional Listing Data#

Finished product
Yes
Brand name base
Snugell
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.13 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5UM2KM3W7
Rxcui1039012

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