FDA.reportPublic FDA data

POVIDONE-IODINE

Product NDC
46414-7777
11-digit product format
464147777
Labeler code
46414
Product ID
46414-7777_a0c3cfbd-f346-4c1b-be91-c04b077c4bd3
Type
HUMAN OTC DRUG
Nonproprietary name
POVIDONE-IODINE
Dosage form
SOLUTION
Route
TOPICAL
Labeler
James Alexander Corporation
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1976-02-14
Substance
POVIDONE-IODINE
Active strength
10 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05unfinished productproduct263afe128892…91768de4ddbe…
2019-12-08 06:16 UTC · source 2019-12-05unfinished packagepackage46414-7777-5263afe128892…91768de4ddbe…
2019-06-01 22:24 UTC · source 2019-05-30unfinished productproduct5b2001dcd8f5…54b53d4dc9e4…
2019-06-01 22:24 UTC · source 2019-05-30unfinished packagepackage46414-7777-55b2001dcd8f5…54b53d4dc9e4…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
POVIDONE-IODINE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POVIDONE-IODINE10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
85H0HZU99MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312564Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
181a6363-2249-45f0-a28b-79f2c5ffad59Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46414-7777-2POVIDONE-IODINE0.6 mL in 1 VIAL, SINGLE-USESOLUTION0.69
46414-7777-2POVIDONE-IODINE100 in 1 CONTAINERSOLUTION1009
46414-7777-3POVIDONE-IODINE10 in 1 CONTAINERSOLUTION109
46414-7777-3POVIDONE-IODINE0.6 mL in 1 VIAL, SINGLE-USESOLUTION0.69

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POVIDONE-IODINEACTIVE INGREDIENT85H0HZU99MPOVIDONE-IODINE SOLUTION [JAMES ALEXANDER CORPORATION]2
IODINEACTIVE MOIETY9679TC07X4POVIDONE-IODINE SOLUTION [JAMES ALEXANDER CORPORATION]2
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPPOVIDONE-IODINE SOLUTION [JAMES ALEXANDER CORPORATION]2
nonoxynol-9INACTIVE INGREDIENT48Q180SH9TPOVIDONE-IODINE SOLUTION [JAMES ALEXANDER CORPORATION]2
phosphate ionINACTIVE INGREDIENTNK08V8K8HRPOVIDONE-IODINE SOLUTION [JAMES ALEXANDER CORPORATION]2
sodium hydroxideINACTIVE INGREDIENT55X04QC32IPOVIDONE-IODINE SOLUTION [JAMES ALEXANDER CORPORATION]2
waterINACTIVE INGREDIENT059QF0KO0RPOVIDONE-IODINE SOLUTION [JAMES ALEXANDER CORPORATION]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46414-7777POVIDONE-IODINE SOLUTION [JAMES ALEXANDER CORPORATION]8Current NDC, Legacy NDC, 4 package rows20241217_181a6363-2249-45f0-a28b-79f2c5ffad59.zip

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 92 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
germstarCitrusETHYL ALCOHOLSoaptronic, LLC779abef7-53ff-47c3-b7e6-27570eb055b32024-12-19WarningsExact identifier
application number: M003
germstarGelETHYL ALCOHOLSoaptronic, LLCb5fd6c3c-d452-74e6-e053-2995a90a90902024-12-19WarningsExact identifier
application number: M003
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLJell Pharmaceuticals Pvt. Ltd.cd98812b-017a-2cd2-e053-2a95a90a38ce2024-12-18WarningsExact identifier
application number: M003
Isopropyl Rubbing Alcohol 50%ISOPROPYL ALCOHOLMY IMPORTS LLCd4d72406-067d-1f67-e053-2995a90a1a9f2024-12-18WarningsExact identifier
application number: M003
AMORAY 70% ISOPROPYL RUBBING ALCOHOLISOPROPYL ALCOHOLMY IMPORT USA INC7114b527-106b-4629-867c-63dba13635a22024-12-18WarningsExact identifier
application number: M003
AMERICAN REDCROSS 70% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREENISOPROPYL ALCOHOLMY IMPORTS USA LLCd4d7e7f8-7c8a-2b51-e053-2995a90a63d02024-12-18WarningsExact identifier
application number: M003
ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREENISOPROPYL ALCOHOLMy Imports USA, LLCd4d77ec3-4930-74f0-e053-2a95a90a962a2024-12-18WarningsExact identifier
application number: M003
91% Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLMY IMPORTS USA LLCd4d7adaf-c0fd-82fa-e053-2995a90ab9f62024-12-18WarningsExact identifier
application number: M003
ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREENISOPROPYL ALCOHOLMY IMPORTS USA, LLCde47bf08-f64e-781d-e053-2a95a90ab08f2024-12-18WarningsExact identifier
application number: M003
AMERICAN REDCROSS 91% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREENISOPROPYL ALCOHOLMY IMPORTS USA LLCd4d80ae4-3fba-4605-e053-2a95a90a21192024-12-18WarningsExact identifier
application number: M003
American Red Cross 50% Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLMY IMPORTS USA LLCde47a879-9cd0-5fbb-e053-2a95a90a1fba2024-12-18WarningsExact identifier
application number: M003
RUBBING ALCOHOLALCOHOLINTERNATIONAL GENERAL TRADING CORPbd5ee961-1d64-0d9d-e053-2a95a90a60102024-12-18WarningsExact identifier
application number: M003
70% Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLSZY Holdings, LLC dba EverReady First Aid1e39b0f4-66d1-47ac-aed6-d6ac019888ce2024-12-18WarningsExact identifier
application number: M003
RUBBING ALCOHOLALCOHOLINTERNATIONAL GENERAL TRADING CORPbd5eb0df-cd2d-691c-e053-2995a90a25112024-12-18WarningsExact identifier
application number: M003
Isopropyl Rubbing Alcohol 70%ISOPROPYL ALCOHOLFirst Aid Research Corp.7d1c0382-31b3-48d0-a514-c5cc45a2299e2024-12-18WarningsExact identifier
application number: M003
First Aid Only First Aid-BurnBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEAcme United Corporationf31a44ff-e4ac-de1e-e053-2a95a90ab0362024-12-18WarningsExact identifier
application number: M003
Hand Sanitizer (Lavender Rosemary)HAND SANITIZER SPRAYTubby Todd2992a52a-21a9-18be-e063-6294a90a834d2024-12-18WarningsExact identifier
application number: M003
CVS Decolorized IodineALCOHOLCVS Pharmacyd9f1a1aa-f402-4c0d-96e8-eeb5eb5cfacd2024-12-18WarningsExact identifier
application number: M003
De La Cruz Decolorized IodineETHYL ALCOHOLDLC Laboratories, Inc.5d8f6aaa-0b87-1166-e053-2991aa0a297f2024-12-18WarningsExact identifier
application number: M003
Humco Povidone IodinePOVIDONE IODINE 10%Humco Holding Group, Inc.1e078022-f32c-48bd-8add-f83aebcc58122024-12-18WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312564povidone-iodine 10 % Topical SolutionPSN181a6363-2249-45f0-a28b-79f2c5ffad599
312564povidone-iodine 100 MG/ML Topical SolutionSCD181a6363-2249-45f0-a28b-79f2c5ffad599
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSY181a6363-2249-45f0-a28b-79f2c5ffad599
1299889ammonia 15 % Nasal InhalantPSN3c4514b8-4069-45cc-9cc3-0992e0458f802
1299889ammonia 15 % Nasal InhalantPSN27e404a1-bbcd-4c3b-b664-07037f88a5022
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSN27e404a1-bbcd-4c3b-b664-07037f88a5022
312564povidone-iodine 10 % Topical SolutionPSN27e404a1-bbcd-4c3b-b664-07037f88a5022
312564povidone-iodine 10 % Topical SolutionPSN3c4514b8-4069-45cc-9cc3-0992e0458f802
1299889ammonia 150 MG/ML Nasal InhalantSCD27e404a1-bbcd-4c3b-b664-07037f88a5022
1299889ammonia 150 MG/ML Nasal InhalantSCD3c4514b8-4069-45cc-9cc3-0992e0458f802
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCD27e404a1-bbcd-4c3b-b664-07037f88a5022
312564povidone-iodine 100 MG/ML Topical SolutionSCD27e404a1-bbcd-4c3b-b664-07037f88a5022
312564povidone-iodine 100 MG/ML Topical SolutionSCD3c4514b8-4069-45cc-9cc3-0992e0458f802
1299889ammonia 0.045 GM per 0.3 ML Nasal InhalantSY3c4514b8-4069-45cc-9cc3-0992e0458f802
1299889ammonia 0.045 GM per 0.3 ML Nasal InhalantSY27e404a1-bbcd-4c3b-b664-07037f88a5022
1299889ammonia 0.3 ML Nasal InhalantSY27e404a1-bbcd-4c3b-b664-07037f88a5022
1299889ammonia 0.3 ML Nasal InhalantSY3c4514b8-4069-45cc-9cc3-0992e0458f802
1299889ammonia 15 % Nasal InhalantSY27e404a1-bbcd-4c3b-b664-07037f88a5022
1299889ammonia 15 % Nasal InhalantSY3c4514b8-4069-45cc-9cc3-0992e0458f802
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSY27e404a1-bbcd-4c3b-b664-07037f88a5022
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSY27e404a1-bbcd-4c3b-b664-07037f88a5022
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSY3c4514b8-4069-45cc-9cc3-0992e0458f802
312564povidone-iodine 10 % Topical SolutionPSNa9c7bd20-9849-4e03-b628-ebfc324466581
312564povidone-iodine 10 % Topical SolutionPSN37c709ae-ef37-0b46-e063-6394a90af8611
312564povidone-iodine 100 MG/ML Topical SolutionSCD37c709ae-ef37-0b46-e063-6394a90af8611
312564povidone-iodine 100 MG/ML Topical SolutionSCDa9c7bd20-9849-4e03-b628-ebfc324466581
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSYa9c7bd20-9849-4e03-b628-ebfc324466581
312564povidone-iodine 10 % (titratable iodine 1 % ) Topical SolutionSY37c709ae-ef37-0b46-e063-6394a90af8611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46414-7777-246414777702100 VIAL, SINGLE-USE in 1 CONTAINER (46414-7777-2) / .6 mL in 1 VIAL, SINGLE-USE1976-02-140000-00-00NoNoCurrent
46414-7777-34641477770310 VIAL, SINGLE-USE in 1 CONTAINER (46414-7777-3) / .6 mL in 1 VIAL, SINGLE-USE1976-02-140000-00-00NoNoCurrent