Halodine Oral Rinse

Product NDC: 78371-201
Requested package NDC: 78371-201-03
11-digit product format: 783710201
Labeler code: 78371
Product ID: 78371-201_1100b895-e9b7-42f9-b787-c41d102e92a5
Type: HUMAN OTC DRUG
Nonproprietary name: Povidone-Iodine
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Halodine LLC
Application: part356
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-05-15
Marketing end: 0000-00-00
Substance: POVIDONE-IODINE
Active strength: 2 mg/mL
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	78371-201	78371-201-03	I	Inactivated by FDA		2026-10-05

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 · 18 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5f30b278-5791-4113-8781-878a9221ef8a	Product name	2	20230125
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
78371-201-01	2022-01-28	C162847	48780-1	d6a99b39-7ee8-a426-e053-dadaa90af4c2	Halodine Oral Rinse
78371-201-02	2022-01-28	C162847	48780-1	d6a99b39-7ee8-a426-e053-dadaa90af4c2	Halodine Oral Rinse
78371-201-03	2022-01-28	C162847	48780-1	d6a99b39-7ee8-a426-e053-dadaa90af4c2	Halodine Oral Rinse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
78371-201-01	Halodine Oral Rinse	3.2 mL in 1 AMPULE	SOLUTION	3.2	3
78371-201-01	Halodine Oral Rinse	100 in 1 CARTON	SOLUTION	100	3
78371-201-02	Halodine Oral Rinse	3.8 mL in 1 AMPULE	SOLUTION	3.8	3
78371-201-02	Halodine Oral Rinse	200 in 1 CARTON	SOLUTION	200	3
78371-201-03	Halodine Oral Rinse	10 in 1 CARTON	SOLUTION	10	3
78371-201-03	Halodine Oral Rinse	3.2 mL in 1 AMPULE	SOLUTION	3.2	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
78371-201	HALODINE ORAL RINSE (POVIDONE-IODINE) SOLUTION [HALODINE LLC]	3	Legacy NDC, 6 package rows	20201117_a9ee4c33-4a5b-3a1f-e053-2995a90aa515.zip

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
2380869	povidone-iodine 1.75 % Topical Solution	PSN	a9ee4c33-4a5b-3a1f-e053-2995a90aa515	3
2380869	povidone-iodine 17.5 MG/ML Topical Solution	SCD	a9ee4c33-4a5b-3a1f-e053-2995a90aa515	3
2380869	povidone-iodine 1.75 % (titratable iodine 0.175 % ) Topical Solution	SY	a9ee4c33-4a5b-3a1f-e053-2995a90aa515	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
78371-201-03	78371020103	10 AMPULE in 1 CARTON (78371-201-03) > 3.2 mL in 1 AMPULE	10 ampule	2020-10-28	0000-00-00	No	No	Current