FDA.reportPublic FDA data

Dakins Full

Manufacturer
Century Pharmaceuticals, Inc.
Effective date
2026-02-17
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:46:04

Label at a glance#

ProductDakins Full
Active ingredientSODIUM HYPOCHLORITE
Label structure12 sections

Storage and handling

Other Information Store at room temperature. May bleach clothing. Keep container closed when not using.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Sodium Hypochlorite 0.50%

OTC - PURPOSE SECTION

Antimicrobial

INDICATIONS & USAGE SECTION

Uses

To prevent and treat infections of the skin and tissue.

Pre and post surgery   Cuts, abrasions and skin ulcers

WARNINGS SECTION

For external use only.

OTC - STOP USE SECTION

Stop use and ask a doctor if redness, irritation, swelling or pain persists or increases.

OTC - DO NOT USE SECTION

Do not use if sensitive to chlorine compounds.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

Pour on or apply to affected area. For wound management, use as an irrigant, cleanser, or the wetting agent for a wet-to-moist dressing.

Apply once daily for lightly to moderately exudative wounds.  Apply twice daily for highly exudative or highly contaminated wounds. Protect intact skin

with a moisture barrier ointment or skin sealant as needed.

STORAGE AND HANDLING SECTION

Other Information

Store at room temperature.

May bleach clothing.

Keep container closed when not using.

INACTIVE INGREDIENT SECTION

Purified Water, Sodium Bicarbonate, Sodium Hydroxide

OTC - QUESTIONS SECTION

Questions or Comments ?

(317) 849-4210 or 1-866-343-2576, Mon-Fri, 9AM to 4PM EST

Century Pharmaceuticals, Inc. - Indianapolis, IN 46256

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

dakinsfulldakinsfull

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313049sodium hypochlorite 0.5 % Topical SolutionPSN7
313049sodium hypochlorite 5 MG/ML Topical SolutionSCD7
313049Dakin's full strength 0.5 % Topical SolutionSY7

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130304360946160GTIN-13: 0304360946160
EAN-13: 0304360946160
GTIN-12: 304360946160
UPC-A: 304360946160
GTIN storage (14 digits): 00304360946160		dakinsfull.jpg

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
IngredientTypeUNIISPL versionUploaded
Sodium HypochloriteACTIVE INGREDIENTDY38VHM5OD5
HYPOCHLOROUS ACIDACTIVE MOIETY712K4CDC105
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QO5
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I5
WATERINACTIVE INGREDIENT059QF0KO0R5

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0436-09460436-0946-16

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM BICARBONATE8MDF5V39QOIACT
WATER059QF0KO0RIACT
SODIUM HYPOCHLORITEDY38VHM5ODACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 6 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOSOLUTION / RESPIRATORY (INHALATION)2 %w/wExact identifier — unii+dosage form
4 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOSOLUTION / ORALADJ PHExact identifier — unii+dosage form
4 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOSOLUTION / RESPIRATORY (INHALATION)2 %w/wExact identifier — unii+dosage form
4 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / TOPICAL39 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOSOLUTION / ORALADJ PHExact identifier — unii+dosage form
4 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / TOPICAL39 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dakins FullSODIUM HYPOCHLORITECentury Pharmaceuticals, Inc.3d72b72c-2949-4eb6-b64c-6c4aef0eddd92026-02-17WarningsExact identifier
ndc (package): 0436-0946-16
ndc (product): 0436-0946
ndc11 (package): 00436094616
spl id: 4b0ae3e4-c66a-bbac-e063-6294a90a9ce8
spl set id: 3d72b72c-2949-4eb6-b64c-6c4aef0eddd9

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.