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 35 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hand Sanitizer Cherry Pop	ALCOHOL	Scent Theory Products LLC	4a18b475-fd3b-10a3-e063-6294a90a4f47	2026-02-05	Warnings	Exact identifier application number: M003
Hand Sanitizer Ocean Splash	ALCOHOL	Scent Theory Products LLC	4a18d7b2-94ca-7924-e063-6394a90af3d1	2026-02-05	Warnings	Exact identifier application number: M003
Hand Sanitizer Banana Creme	ALCOHOL	Scent Theory Products LLC	4a18e8e0-43e3-70d8-e063-6294a90adf4b	2026-02-05	Warnings	Exact identifier application number: M003
Hand Sanitizer Juicy Pear	ALCOHOL	Scent Theory Products LLC	4a18e8e0-43e5-70d8-e063-6294a90adf4b	2026-02-05	Warnings	Exact identifier application number: M003
Hand Sanitizer Pink Melon	ALCOHOL	Scent Theory Products LLC	4a18ec9c-d466-63c1-e063-6294a90a1122	2026-02-05	Warnings	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Pharmacy Value Alliance, LLC	528011d7-8c6d-4940-bee1-52b39acef40d	2026-02-05	Warnings, Adverse reactions	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Publix Super Markets, Inc.	14aecc7b-c68a-4cb9-863f-475e204f66a5	2026-02-05	Warnings	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	Publix Super Markets, Inc.	250d12ba-524e-4283-ad98-b7318f414ee0	2026-02-05	Warnings	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Publix Super Markets, Inc.	b3b5324b-ee2c-4f87-9bb9-81d3d85f73ee	2026-02-05	Warnings	Exact identifier application number: M003
Hand Sanitizer 8 oz. Vitamin E 70 v/v	ETHYL ALCOHOL	Ningbo Rejoice International	a26a6f97-7166-0a40-e053-2a95a90a4b68	2026-02-05	Warnings	Exact identifier application number: M003
Hand Sanitizer Vitamin E and Aloe Vera	ETHYL ALCOHOL	Ningbo Rejoice International	a26a4676-6eae-088a-e053-2a95a90a7c1a	2026-02-05	Warnings	Exact identifier application number: M003
Isopropyl alcohol 50 percent	ISOPROPYL ALCOHOL	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	b1b52183-3296-48b2-b3d3-821c141b0bea	2026-02-05	Warnings	Exact identifier application number: M003
Isopropyl alcohol 50 percent	ISOPROPYL ALCOHOL	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	ee67fb96-fa2c-4542-8fdb-f2ccd885ee53	2026-02-05	Warnings	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Dyad Medical Sourcing, LLC	b5c9e222-10eb-4cea-af70-213a77fcc865	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	GoBrands, Inc.	0fb3db50-4132-07dc-e063-6294a90a8168	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	GoBrands, Inc.	0fa3615b-4181-1bd8-e063-6294a90ad129	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	Greenbrier International, Inc	ce4e301b-af91-4fa0-a64c-4b235a5ff07d	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M003
Terramed Just Think Comfort Armor Antibacterial Cleansing Bar	BENZALKONIUM CHLORIDE	Rida LLC	68e59a77-6a0c-42e2-a6a9-1353470d2e08	2026-02-04	Warnings	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Grocery Outlet, Inc.	3dff8c83-7c33-7bca-e063-6394a90a675f	2026-02-04	Warnings, Adverse reactions	Exact identifier application number: M003
Isopropyl alcohol	ISOPROPYL ALCOHOL	Grocery Outlet, Inc.	3dffba95-71c4-a2b0-e063-6394a90aaeb3	2026-02-04	Warnings, Adverse reactions	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