FDA.reportPublic FDA data

Dakins Full

Product NDC
0436-0946
11-digit product format
004360946
Labeler code
0436
Product ID
0436-0946_4b0ae3e4-c66a-bbac-e063-6294a90a9ce8
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Hypochlorite
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Century Pharmaceuticals, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
1983-12-08
Substance
SODIUM HYPOCHLORITE
Active strength
5 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dakins Full
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM HYPOCHLORITE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiDY38VHM5OD
Rxcui313049

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0436-0946-162021-01-29C16284748780-1ba0f9c33-5775-a910-e053-dadaa90a0b85Dakin's Full Strength (Sodium Hypochlorite 0.5%)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0436-0946-16Dakins Full473 mL in 1 BOTTLESOLUTION4737

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0436-0946-16ML - Milliliter0436-09466d7a7124-a04a-458e-bc28-9ad8636dfd6212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Sodium HypochloriteACTIVE INGREDIENTDY38VHM5ODDAKINS FULL (SODIUM HYPOCHLORITE) SOLUTION [CENTURY PHARMACEUTICALS, INC.]5
HYPOCHLOROUS ACIDACTIVE MOIETY712K4CDC10DAKINS FULL (SODIUM HYPOCHLORITE) SOLUTION [CENTURY PHARMACEUTICALS, INC.]5
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QODAKINS FULL (SODIUM HYPOCHLORITE) SOLUTION [CENTURY PHARMACEUTICALS, INC.]5
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDAKINS FULL (SODIUM HYPOCHLORITE) SOLUTION [CENTURY PHARMACEUTICALS, INC.]5
WATERINACTIVE INGREDIENT059QF0KO0RDAKINS FULL (SODIUM HYPOCHLORITE) SOLUTION [CENTURY PHARMACEUTICALS, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0436-0946DAKINS FULL (SODIUM HYPOCHLORITE) SOLUTION [CENTURY PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 1 package rows20190208_3d72b72c-2949-4eb6-b64c-6c4aef0eddd9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313049sodium hypochlorite 0.5 % Topical SolutionPSN3d72b72c-2949-4eb6-b64c-6c4aef0eddd97
313049sodium hypochlorite 5 MG/ML Topical SolutionSCD3d72b72c-2949-4eb6-b64c-6c4aef0eddd97
313049Dakin's full strength 0.5 % Topical SolutionSY3d72b72c-2949-4eb6-b64c-6c4aef0eddd97

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0436-0946-1600436094616473 mL in 1 BOTTLE (0436-0946-16) 473 ml2006-05-24NoNoCurrent