FDA.reportPublic FDA data

Di-Dak-Sol

Product NDC
0436-0669
11-digit product format
004360669
Labeler code
0436
Product ID
0436-0669_4b0adcc9-ddf5-aeb4-e063-6294a90aafab
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Hypochlorite
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Century Pharmaceuticals, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2001-02-05
Substance
SODIUM HYPOCHLORITE
Active strength
.125 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0436-0669-162021-01-29C16284748780-1ba0f9c33-394b-a910-e053-dadaa90a0b85Di-Dak-Sol (Sodium Hypochlorite 0.0125%)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0436-0669-16Di-Dak-Sol473 mL in 1 BOTTLESOLUTION4739

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0436-0669-16ML - Milliliter0436-0669e5ff1bb1-876f-4c7c-b3c4-9730e7b22c7612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Sodium HypochloriteACTIVE INGREDIENTDY38VHM5ODDI-DAK-SOL (SODIUM HYPOCHLORITE) SOLUTION [CENTURY PHARMACEUTICALS, INC.]7
HYPOCHLOROUS ACIDACTIVE MOIETY712K4CDC10DI-DAK-SOL (SODIUM HYPOCHLORITE) SOLUTION [CENTURY PHARMACEUTICALS, INC.]7
Sodium BicarbonateINACTIVE INGREDIENT8MDF5V39QODI-DAK-SOL (SODIUM HYPOCHLORITE) SOLUTION [CENTURY PHARMACEUTICALS, INC.]7
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IDI-DAK-SOL (SODIUM HYPOCHLORITE) SOLUTION [CENTURY PHARMACEUTICALS, INC.]7
WaterINACTIVE INGREDIENT059QF0KO0RDI-DAK-SOL (SODIUM HYPOCHLORITE) SOLUTION [CENTURY PHARMACEUTICALS, INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0436-0669DI-DAK-SOL (SODIUM HYPOCHLORITE) SOLUTION [CENTURY PHARMACEUTICALS, INC.]8Current NDC, Legacy NDC, 1 package rows20190208_fdf5975e-20fa-41e4-8cd6-3d1d7c7b2d2c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
979137DI-DAK-SOL 0.0125 % Topical SolutionPSNfdf5975e-20fa-41e4-8cd6-3d1d7c7b2d2c9
665046sodium hypochlorite 0.0125 % Topical SolutionPSNfdf5975e-20fa-41e4-8cd6-3d1d7c7b2d2c9
979137sodium hypochlorite 0.125 MG/ML Topical Solution [Di-Dak-Sol]SBDfdf5975e-20fa-41e4-8cd6-3d1d7c7b2d2c9
665046sodium hypochlorite 0.125 MG/ML Topical SolutionSCDfdf5975e-20fa-41e4-8cd6-3d1d7c7b2d2c9
979137Di-Dak-Sol 0.0125 % Topical SolutionSYfdf5975e-20fa-41e4-8cd6-3d1d7c7b2d2c9
979137Di-Dak-Sol 0.125 MG/ML Topical SolutionSYfdf5975e-20fa-41e4-8cd6-3d1d7c7b2d2c9
665046sodium hypochlorite 0.0125 % Topical SolutionSYfdf5975e-20fa-41e4-8cd6-3d1d7c7b2d2c9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0436-0669-1600436066916473 mL in 1 BOTTLE (0436-0669-16) 473 ml2006-05-24NoNoHistorical