FDA.reportPublic FDA data

Dakins Half

Product NDC
0436-0936
11-digit product format
004360936
Labeler code
0436
Product ID
0436-0936_4b0ae5b3-5200-5687-e063-6394a90a484a
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Hypochlorite
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Century Pharmaceuticals, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
1986-06-09
Substance
SODIUM HYPOCHLORITE
Active strength
2.5 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 Half
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM HYPOCHLORITE2.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiDY38VHM5OD
Rxcui313048

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
0436-0936-162021-01-29C16284748780-1ba0f9c33-3948-a910-e053-dadaa90a0b85Dakin's Half Strength (Sodium Hypochlorite 0.25%)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0436-0936-16Dakins Half473 mL in 1 BOTTLESOLUTION4738

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0436-0936-16ML - Milliliter0436-093673232c90-7a43-44f2-81c6-77dfa64066d812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM HYPOCHLORITEACTIVE INGREDIENTDY38VHM5ODDAKINS HALF (SODIUM HYPOCHLORITE) SOLUTION [CENTURY PHARMACEUTICALS, INC.]6
HYPOCHLOROUS ACIDACTIVE MOIETY712K4CDC10DAKINS HALF (SODIUM HYPOCHLORITE) SOLUTION [CENTURY PHARMACEUTICALS, INC.]6
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QODAKINS HALF (SODIUM HYPOCHLORITE) SOLUTION [CENTURY PHARMACEUTICALS, INC.]6
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IDAKINS HALF (SODIUM HYPOCHLORITE) SOLUTION [CENTURY PHARMACEUTICALS, INC.]6
WATERINACTIVE INGREDIENT059QF0KO0RDAKINS HALF (SODIUM HYPOCHLORITE) SOLUTION [CENTURY PHARMACEUTICALS, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0436-0936DAKINS HALF (SODIUM HYPOCHLORITE) SOLUTION [CENTURY PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 1 package rows20190208_a0ee103e-1f9c-4ffb-aafe-bb49d30f7816.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313048sodium hypochlorite 0.25 % Topical SolutionPSNa0ee103e-1f9c-4ffb-aafe-bb49d30f78168
313048sodium hypochlorite 2.5 MG/ML Topical SolutionSCDa0ee103e-1f9c-4ffb-aafe-bb49d30f78168
313048Dakin's half strength 0.25 % Topical SolutionSYa0ee103e-1f9c-4ffb-aafe-bb49d30f78168

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0436-0936-1600436093616473 mL in 1 BOTTLE (0436-0936-16) 473 ml2006-05-24NoNoCurrent