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 date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2019-12-08 06:16 UTC · source 2019-12-05	unfinished product	product		`263afe128892…`	`91768de4ddbe…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished package	package	46414-7777-5	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished product	product		`5b2001dcd8f5…`	`54b53d4dc9e4…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished package	package	46414-7777-5	`5b2001dcd8f5…`	`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
Ingredient	Strength
POVIDONE-IODINE	10 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
85H0HZU99M	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
181a6363-2249-45f0-a28b-79f2c5ffad59	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
070fbed5-7088-434a-a7ce-f2a64d8d40ac	Product name	2	20260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80f	Product name	5	20250819
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
860a93dc-4863-49cc-b284-6bbe8191bc48	Product name	4	20250214
eaba870a-6a9d-442e-8643-87b3f558a451	Product name	1	20250117
5f30b278-5791-4113-8781-878a9221ef8a	Product name	2	20230125
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57	Product name	3	20210602
aed701d5-9c75-dfaf-7154-cde46179faea	Product name	9	20200313
2a70c781-a755-4d76-b20a-a958acfbdcdc	Product name	2	20190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5	Product name	1	20180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22	Product name	1	20180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5c	Product name	1	20180619
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
332d03e4-aa24-4b11-841a-02bf41081920	Product name	1	20171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
41e9d6cf-3ed7-4c44-a57e-0685058d0896	Product name	1	20170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99	Product name	1	20170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8c	Product name	1	20150421
68ed98f8-24c2-44a0-944a-6d36e82ce25a	Product name	1	20141222
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
1cd42bc2-a430-c72b-636d-991b235fbf80	Product name	1	20140508
49fa150c-f0de-cce7-3d9c-993ed81c5698	Product name	1	20140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ff	Product name	1	20140508
9137811f-f279-8640-5aeb-99fa2145d64d	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
46414-7777-2	POVIDONE-IODINE	0.6 mL in 1 VIAL, SINGLE-USE	SOLUTION	0.6	9
46414-7777-2	POVIDONE-IODINE	100 in 1 CONTAINER	SOLUTION	100	9
46414-7777-3	POVIDONE-IODINE	10 in 1 CONTAINER	SOLUTION	10	9
46414-7777-3	POVIDONE-IODINE	0.6 mL in 1 VIAL, SINGLE-USE	SOLUTION	0.6	9

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
POVIDONE-IODINE	ACTIVE INGREDIENT	85H0HZU99M	POVIDONE-IODINE SOLUTION [JAMES ALEXANDER CORPORATION]	2
IODINE	ACTIVE MOIETY	9679TC07X4	POVIDONE-IODINE SOLUTION [JAMES ALEXANDER CORPORATION]	2
citric acid monohydrate	INACTIVE INGREDIENT	2968PHW8QP	POVIDONE-IODINE SOLUTION [JAMES ALEXANDER CORPORATION]	2
nonoxynol-9	INACTIVE INGREDIENT	48Q180SH9T	POVIDONE-IODINE SOLUTION [JAMES ALEXANDER CORPORATION]	2
phosphate ion	INACTIVE INGREDIENT	NK08V8K8HR	POVIDONE-IODINE SOLUTION [JAMES ALEXANDER CORPORATION]	2
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	POVIDONE-IODINE SOLUTION [JAMES ALEXANDER CORPORATION]	2
water	INACTIVE INGREDIENT	059QF0KO0R	POVIDONE-IODINE SOLUTION [JAMES ALEXANDER CORPORATION]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46414-7777	POVIDONE-IODINE SOLUTION [JAMES ALEXANDER CORPORATION]	8	Current NDC, Legacy NDC, 4 package rows	20241217_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 43 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Surgical Scrub Brush/Sponge With Nail Cleaner	POVIDONE IODINE	Xinxiang Xinda Technology Co.,Ltd	12585502-c043-6ffb-e063-6394a90a6602	2026-01-08	Warnings	Exact identifier application number: M003
Thompson Alcohol	ISOPROPYL ALCOHOL	Thompson	f539db3b-f309-6a60-e053-2a95a90a5a9b	2026-01-08	Warnings	Exact identifier application number: M003
Germ-Away	ANTI-MICROBIAL	Unico International Trading Corp	a7d35899-8b70-14f0-e053-2995a90a5ce8	2026-01-08	Warnings	Exact identifier application number: M003
Germ Away	ANTI-MICROBIAL WIPE	Unico International Trading Corp	a6b4eec4-0b12-3a00-e053-2a95a90a7835	2026-01-08	Warnings	Exact identifier application number: M003
Germ-Away	ANTI-MICROBIAL	Unico International Trading Corp	a7d0ce42-9076-143c-e053-2995a90aeeb6	2026-01-08	Warnings	Exact identifier application number: M003
Wipex	ANTIBACTERIAL WIPE	Unico International Trading Corporation	261c7b8f-4adc-72ec-e063-6394a90a9211	2026-01-08	Warnings	Exact identifier application number: M003
Wipex	ANTIBACTERIAL WIPE	Unico International Trading Corporation	144453a2-8335-77be-e063-6394a90ab676	2026-01-08	Warnings	Exact identifier application number: M003
Germ-Away	ANTI-MICROBIAL	Unico International Trading Corp	a7d40204-3f69-7fb7-e053-2995a90a278b	2026-01-08	Warnings	Exact identifier application number: M003
Germ-Away	ANTIBACTERIAL HAND WIPE	Unico International Trading Corp	ad7d8546-d440-e661-e053-2a95a90a8fd3	2026-01-08	Warnings	Exact identifier application number: M003
Germ-Away	ANTI-MICROBIAL	Unico International Trading Corp	a7d47c07-12bd-3c8f-e053-2a95a90a9564	2026-01-08	Warnings	Exact identifier application number: M003
Germ-Away	ANTI-MICROBIAL	Unico International Trading Corp	a7d7f260-f5be-7940-e053-2995a90aaa03	2026-01-08	Warnings	Exact identifier application number: M003
Germ-Away	ANTIBACTERIAL	Unico International Trading Corp	ada02f20-07ef-9e90-e053-2995a90a0e8b	2026-01-08	Warnings	Exact identifier application number: M003
Germ-Away	ANTI-BACTERIAL	Unico International Trading Corp	adb59182-6541-2b35-e053-2a95a90a0f71	2026-01-08	Warnings	Exact identifier application number: M003
Castellani Paint 1.5%	PHENOL	The Podiatree Company	a10f18e0-b47c-424b-847e-bcc25aa250a4	2026-01-08	Warnings	Exact identifier application number: M003
Castellani Paint 1.5%	PHENOL	The Podiatree Company	5b8cff3c-71d2-418f-a43d-f570aa5408fd	2026-01-08	Warnings	Exact identifier application number: M003
Fortinia ID	PHENOL	The Podiatree Company	60c88eb7-22fe-4881-e053-2a91aa0a70ce	2026-01-08	Warnings	Exact identifier application number: M003
Gentian Violet 2%	GENTIAN VIOLET 2%	The Podiatree Company	60ba9bb0-cc7a-1ccf-e053-2a91aa0ac4b8	2026-01-08	Warnings	Exact identifier application number: M003
Isopropyl Rubbing Alcohol	ISOPROPYL ALCOHOL	NDC, Inc.	07bfadf4-7452-4c7a-b60e-feb658b92e73	2026-01-08	Warnings	Exact identifier application number: M003
Hydrogen Peroxide 3%	HYDROGEN PEROXIDE 3%	Epic Medical Supply Corp.	0da45476-46c3-428c-a2d9-70865d2b1277	2026-01-08	Warnings	Exact identifier application number: M003
Roll On Anti Perspirant Alcohol Free	ALUMINUM CHLOROHYDRATE	Medline Industries, LP	4f706801-dc2d-48c4-aa06-92207d86e55e	2026-01-08	Warnings	Exact identifier application number: M003

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
85H0HZU99M	POVIDONE-IODINE	25655-41-8	POVIDONE-IODINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312564	povidone-iodine 10 % Topical Solution	PSN	181a6363-2249-45f0-a28b-79f2c5ffad59	9
312564	povidone-iodine 100 MG/ML Topical Solution	SCD	181a6363-2249-45f0-a28b-79f2c5ffad59	9
312564	povidone-iodine 10 % (titratable iodine 1 % ) Topical Solution	SY	181a6363-2249-45f0-a28b-79f2c5ffad59	9
1299889	ammonia 15 % Nasal Inhalant	PSN	3c4514b8-4069-45cc-9cc3-0992e0458f80	2
1299889	ammonia 15 % Nasal Inhalant	PSN	27e404a1-bbcd-4c3b-b664-07037f88a502	2
1012100	benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical Cream	PSN	27e404a1-bbcd-4c3b-b664-07037f88a502	2
312564	povidone-iodine 10 % Topical Solution	PSN	27e404a1-bbcd-4c3b-b664-07037f88a502	2
312564	povidone-iodine 10 % Topical Solution	PSN	3c4514b8-4069-45cc-9cc3-0992e0458f80	2
1299889	ammonia 150 MG/ML Nasal Inhalant	SCD	27e404a1-bbcd-4c3b-b664-07037f88a502	2
1299889	ammonia 150 MG/ML Nasal Inhalant	SCD	3c4514b8-4069-45cc-9cc3-0992e0458f80	2
1012100	benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical Cream	SCD	27e404a1-bbcd-4c3b-b664-07037f88a502	2
312564	povidone-iodine 100 MG/ML Topical Solution	SCD	27e404a1-bbcd-4c3b-b664-07037f88a502	2
312564	povidone-iodine 100 MG/ML Topical Solution	SCD	3c4514b8-4069-45cc-9cc3-0992e0458f80	2
1299889	ammonia 0.045 GM per 0.3 ML Nasal Inhalant	SY	3c4514b8-4069-45cc-9cc3-0992e0458f80	2
1299889	ammonia 0.045 GM per 0.3 ML Nasal Inhalant	SY	27e404a1-bbcd-4c3b-b664-07037f88a502	2
1299889	ammonia 0.3 ML Nasal Inhalant	SY	27e404a1-bbcd-4c3b-b664-07037f88a502	2
1299889	ammonia 0.3 ML Nasal Inhalant	SY	3c4514b8-4069-45cc-9cc3-0992e0458f80	2
1299889	ammonia 15 % Nasal Inhalant	SY	27e404a1-bbcd-4c3b-b664-07037f88a502	2
1299889	ammonia 15 % Nasal Inhalant	SY	3c4514b8-4069-45cc-9cc3-0992e0458f80	2
1012100	benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical Cream	SY	27e404a1-bbcd-4c3b-b664-07037f88a502	2
312564	povidone-iodine 10 % (titratable iodine 1 % ) Topical Solution	SY	27e404a1-bbcd-4c3b-b664-07037f88a502	2
312564	povidone-iodine 10 % (titratable iodine 1 % ) Topical Solution	SY	3c4514b8-4069-45cc-9cc3-0992e0458f80	2
312564	povidone-iodine 10 % Topical Solution	PSN	a9c7bd20-9849-4e03-b628-ebfc32446658	1
312564	povidone-iodine 10 % Topical Solution	PSN	37c709ae-ef37-0b46-e063-6394a90af861	1
312564	povidone-iodine 100 MG/ML Topical Solution	SCD	37c709ae-ef37-0b46-e063-6394a90af861	1
312564	povidone-iodine 100 MG/ML Topical Solution	SCD	a9c7bd20-9849-4e03-b628-ebfc32446658	1
312564	povidone-iodine 10 % (titratable iodine 1 % ) Topical Solution	SY	a9c7bd20-9849-4e03-b628-ebfc32446658	1
312564	povidone-iodine 10 % (titratable iodine 1 % ) Topical Solution	SY	37c709ae-ef37-0b46-e063-6394a90af861	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
46414-7777-2	46414777702	100 VIAL, SINGLE-USE in 1 CONTAINER (46414-7777-2) / .6 mL in 1 VIAL, SINGLE-USE	1976-02-14	0000-00-00	No	No	Current
46414-7777-3	46414777703	10 VIAL, SINGLE-USE in 1 CONTAINER (46414-7777-3) / .6 mL in 1 VIAL, SINGLE-USE	1976-02-14	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
POVIDONE IODINE TOPICAL SOLUTION USP	James Alexander Corporation	2025-10-23	HUMAN OTC DRUG LABEL	9
POVIDONE IODINE TOPICAL SOLUTION USP	Acme United Corporation \| Acmne United Corporation	2025-06-17	HUMAN OTC DRUG LABEL	1
gel for burns	Honeywell Safety Products USA, Inc.	2024-01-22	HUMAN OTC DRUG LABEL	7
Model AA-8565CV-ACT Model AA-8565CV	Aerospace Accessory Service, Inc	2021-05-18	MEDICAL DEVICE	3
Model AA-1218 Model AA-1218M Model Z-25-020-03	Aerospace Accessory Service, Inc	2021-05-05	MEDICAL DEVICE	2
Povidone-Iodine	Aerospace Accessory Service, Inc	2021-05-05	MEDICAL DEVICE	2
Model AA-1218CEV	Aerospace Accessory Service, Inc	2021-05-05	MEDICAL DEVICE	2
Model AA-1218CE REV 1	Aerospace Accessory Service, Inc	2021-05-05	MEDICAL DEVICE	2
Model AA-1218PAN	Aerospace Accessory Service, Inc	2021-05-05	MEDICAL DEVICE	2
Model S2001-25CS	Aerospace Accessory Service, Inc	2021-05-05	MEDICAL DEVICE	2
Model 6240-35-001CS	Aerospace Accessory Service, Inc	2021-05-05	MEDICAL DEVICE	2
Model AA 1620FJA	Aerospace Accessory Service, Inc	2021-01-07	MEDICAL DEVICE	1