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

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 Identifiers#

Field, Values table
FieldValues
Unii85H0HZU99M
Rxcui312564

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

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