FDA.reportPublic FDA data

AFCO 5511 Sanifect E3

Product NDC
66949-140
11-digit product format
669490140
Labeler code
66949
Product ID
66949-140_46dec692-429e-3b0f-e063-6394a90ad672
Type
HUMAN OTC DRUG
Nonproprietary name
Ethanol
Dosage form
LIQUID
Route
TOPICAL
Labeler
Zep Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-05
Substance
ALCOHOL
Active strength
70 mL/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AFCO 5511 Sanifect E3
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL70 mL/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3K9958V90M
Rxcui1041849

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66949-140-01AFCO 5511 Sanifect E3208198 mL in 1 DRUMLIQUID2081982
66949-140-02AFCO 5511 Sanifect E36000 mL in 1 CASELIQUID60002
66949-140-03AFCO 5511 Sanifect E33785 mL in 1 CASELIQUID37852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66949-140AFCO 5511 SANIFECT E3 (ETHANOL) LIQUID [ZEP INC.]1Current NDC, 3 package rows20250508_34795eba-9ec4-6401-e063-6394a90af428.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1041849ethanol 70 % Topical SprayPSN34795eba-9ec4-6401-e063-6394a90af4282
1041849ethanol 0.7 ML/ML Topical SpraySCD34795eba-9ec4-6401-e063-6394a90af4282
1041849ethanol 70 % Topical SpraySY34795eba-9ec4-6401-e063-6394a90af4282

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
66949-140-0166949014001208198 mL in 1 DRUM (66949-140-01) 208198 ml2025-05-05NoNoHistorical
66949-140-02669490140026000 mL in 1 CASE (66949-140-02) 6000 ml2025-05-05NoNoHistorical
66949-140-03669490140033785 mL in 1 CASE (66949-140-03) 3785 ml2025-05-05NoNoHistorical