FDA.reportPublic FDA data

BETADINE® Solution Swabstick Povidone-iodineSolution USP, 10% Drug Facts

Manufacturer
Atlantis Consumer Healthcare, Inc.
Effective date
2025-11-11
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:43:23

Label at a glance#

ProductBetadine Solution Swabsticks
Active ingredientPOVIDONE-IODINE
Label structure12 sections

Indications and uses

for preparation of the skin prior to surgery helps reduce bacteria that can potentially cause skin infection

Dosage and administration

tear at slit; pull top of packette across, exposing endof swabstick remove Betadine Solution Swabstick and apply as needed use one time only

Label contents#

Full prescribing information#

Active ingredient Purpose

OTC - ACTIVE INGREDIENT SECTION

Povidone-iodine Solution USP, 10% (equal to1% available iodine)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • for preparation of the skin prior to surgery
  • helps reduce bacteria that can potentially cause skin infection

Warnings

WARNINGS SECTION

For external use only

Do not use this product

OTC - DO NOT USE SECTION

  • in the eyes
  • if you are allergic to iodine or other product ingredients

When using this product

OTC - WHEN USING SECTION

  • prolonged exposure may cause irritation or, rarely, severeskin reactions

Stop using this product

OTC - STOP USE SECTION

  • in rare instances of local irritation or sensitivity
  • if irritation and redness develop and continue for morethan 72 hours

Keep out of reach ofchildren.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Ifswallowed, get medical help or contact a Poison Control Center rightaway

Directions

DOSAGE & ADMINISTRATION SECTION

  • tear at slit; pull top of packette across, exposing endof swabstick
  • remove Betadine Solution Swabstick and apply as needed
  • use one time only

Other information

HOW SUPPLIED SECTION

store between 20˚-25˚C (68˚-77˚F).Avoid freezing and excessive heat above 40˚C (104˚F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

purified water, sodium hydroxide

Dist. by:
Avrio Health L.P.
Stamford, CT 06901-3431

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BetadineSwabsticks — 1 Swab
NDC: 67618-153-01

NDC 67618-153-01
NDC 67618-153-01

BetadineSwabsticks — 3 Swabs
67618-153-03

NDC 67618-153-03
NDC 67618-153-03

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
798176Betadine 10 % Medicated PadPSN8
797730povidone-iodine 10 % Medicated PadPSN8
798176povidone-iodine 100 MG/ML Medicated Pad [Betadine]SBD8
797730povidone-iodine 100 MG/ML Medicated PadSCD8
798176Betadine 10 % Medicated PadSY8
798176Betadine 10 % Topical SwabSY8
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY8
797730povidone-iodine 10 % Medicated PadSY8
797730povidone-iodine 10 % Medicated SwabstickSY8

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67618-153-012022-04-09C16284748780-19d75b9d0-cc70-f424-e053-dadaa90a57ceBETADINE® Solution Swabstick Povidone-iodineSolution USP, 10% Drug Facts
67618-153-012022-04-09C16284748780-19d75b9d0-cc70-f424-e053-dadaa90a57ceBETADINE® Solution Swabstick Povidone-iodineSolution USP, 10% Drug Facts
67618-153-032022-04-09C16284748780-19d75b9d0-cc70-f424-e053-dadaa90a57ceBETADINE® Solution Swabstick Povidone-iodineSolution USP, 10% Drug Facts
67618-153-032022-04-09C16284748780-19d75b9d0-cc70-f424-e053-dadaa90a57ceBETADINE® Solution Swabstick Povidone-iodineSolution USP, 10% Drug Facts
67618-153-012020-01-31C16284748780-19d75b9d0-cc70-f424-e053-dadaa90a57ceBETADINE® Solution Swabstick Povidone-iodineSolution USP, 10% Drug Facts
67618-153-012020-01-31C16284748780-19d75b9d0-cc70-f424-e053-dadaa90a57ceBETADINE® Solution Swabstick Povidone-iodineSolution USP, 10% Drug Facts
67618-153-032020-01-31C16284748780-19d75b9d0-cc70-f424-e053-dadaa90a57ceBETADINE® Solution Swabstick Povidone-iodineSolution USP, 10% Drug Facts
67618-153-032020-01-31C16284748780-19d75b9d0-cc70-f424-e053-dadaa90a57ceBETADINE® Solution Swabstick Povidone-iodineSolution USP, 10% Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67618-153-01BetadineSolution Swabsticks1.9 mL in 1 APPLICATORSOLUTION1.98
67618-153-01BetadineSolution Swabsticks1 in 1 POUCHSOLUTION18
67618-153-03BetadineSolution Swabsticks1.9 mL in 1 APPLICATORSOLUTION1.98
67618-153-03BetadineSolution Swabsticks3 in 1 POUCHSOLUTION38

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67618-153-01EA - Each67618-15340a2da4e-0b59-4182-ad58-aa759214a83b12012-07-24
67618-153-03EA - Each67618-153f4d67978-85f8-4306-af8d-f20f8b9d0ba312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99M1
POVIDONE-IODINEACTIVE MOIETY85H0HZU99M1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP1
NONOXYNOL-9INACTIVE INGREDIENT48Q180SH9T1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I1
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENT94255I6E2T1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67618-15367618-153-01, 67618-153-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
POVIDONE-IODINE85H0HZU99MACTIM

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72024-12-26full-release2026-06-01 00:49:31

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 · 27 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / TOPICAL17 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, DIHYDRATESODIUM PHOSPHATE, DIBASIC, DIHYDRATE94255I6E2TSOLUTION / INTRAVENOUS52 mgExact identifier — unii+dosage form
15 equally ranked IID candidates
NONOXYNOL-9NONOXYNOL-948Q180SH9TCLOTH / TOPICALNAExact identifier — unii+route
6 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, DIHYDRATESODIUM PHOSPHATE, DIBASIC, DIHYDRATE94255I6E2TCREAM / TOPICAL0.25 %w/wExact identifier — unii+route
15 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, DIHYDRATESODIUM PHOSPHATE, DIBASIC, DIHYDRATE94255I6E2TCREAM / TOPICAL0.25 %w/wExact identifier — unii+route
15 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, DIHYDRATESODIUM PHOSPHATE, DIBASIC, DIHYDRATE94255I6E2TGEL / TOPICALNAExact identifier — unii+route
15 equally ranked IID candidates
NONOXYNOL-9NONOXYNOL-948Q180SH9TCLOTH / TOPICALNAExact identifier — unii+route
6 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, DIHYDRATESODIUM PHOSPHATE, DIBASIC, DIHYDRATE94255I6E2TOINTMENT / TOPICAL4 mgExact identifier — unii+route
15 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / TOPICAL39 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / TOPICAL39 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
NONOXYNOL-9NONOXYNOL-948Q180SH9TSOLUTION / OPHTHALMIC0.13 %w/wExact identifier — unii+dosage form
6 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ISOLUTION / TOPICAL39 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / TOPICAL17 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, DIHYDRATESODIUM PHOSPHATE, DIBASIC, DIHYDRATE94255I6E2TGEL / TOPICALNAExact identifier — unii+route
15 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / TOPICAL17 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, DIHYDRATESODIUM PHOSPHATE, DIBASIC, DIHYDRATE94255I6E2TSOLUTION / INTRAVENOUS52 mgExact identifier — unii+dosage form
15 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, DIHYDRATESODIUM PHOSPHATE, DIBASIC, DIHYDRATE94255I6E2TOINTMENT / TOPICAL4 mgExact identifier — unii+route
15 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, DIHYDRATESODIUM PHOSPHATE, DIBASIC, DIHYDRATE94255I6E2TSOLUTION / ORAL2.5 mg/1mlExact identifier — unii+dosage form
15 equally ranked IID candidates
NONOXYNOL-9NONOXYNOL-948Q180SH9TSOLUTION / OPHTHALMIC0.13 %w/wExact identifier — unii+dosage form
6 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, DIHYDRATESODIUM PHOSPHATE, DIBASIC, DIHYDRATE94255I6E2TOINTMENT / TOPICAL4 mgExact identifier — unii+route
15 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, DIHYDRATESODIUM PHOSPHATE, DIBASIC, DIHYDRATE94255I6E2TSOLUTION / ORAL2.5 mg/1mlExact identifier — unii+dosage form
15 equally ranked IID candidates
NONOXYNOL-9NONOXYNOL-948Q180SH9TCLOTH / TOPICALNAExact identifier — unii+route
6 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, DIHYDRATESODIUM PHOSPHATE, DIBASIC, DIHYDRATE94255I6E2TGEL / TOPICALNAExact identifier — unii+route
15 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, DIHYDRATESODIUM PHOSPHATE, DIBASIC, DIHYDRATE94255I6E2TSOLUTION / ORAL2.5 mg/1mlExact identifier — unii+dosage form
15 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, DIHYDRATESODIUM PHOSPHATE, DIBASIC, DIHYDRATE94255I6E2TCREAM / TOPICAL0.25 %w/wExact identifier — unii+route
15 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, DIHYDRATESODIUM PHOSPHATE, DIBASIC, DIHYDRATE94255I6E2TSOLUTION / INTRAVENOUS52 mgExact identifier — unii+dosage form
15 equally ranked IID candidates
NONOXYNOL-9NONOXYNOL-948Q180SH9TSOLUTION / OPHTHALMIC0.13 %w/wExact identifier — unii+dosage form
6 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
Betadine Solution SwabsticksPOVIDONE-IODINEAtlantis Consumer Healthcare, Inc.0707b259-52a4-4ae6-b176-d093865906e72025-11-11WarningsExact identifier
ndc (package): 67618-153-03
ndc (package): 67618-153-01
ndc (product): 67618-153
ndc11 (package): 67618015303
ndc11 (package): 67618015301
spl id: 4357dde4-a121-3be4-e063-6394a90af3c8
spl set id: 0707b259-52a4-4ae6-b176-d093865906e7

Reported adverse events (FAERS/openFDA)#

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