Betadine Gargle

Product NDC: 67618-181
11-digit product format: 676180181
Labeler code: 67618
Product ID: 67618-181_803ae961-c01c-4910-91f7-4f668956d3ad
Type: HUMAN OTC DRUG
Nonproprietary name: POVIDONE-IODINE
Dosage form: SOLUTION
Route: ORAL
Labeler: Atlantis Consumer Healthcare, Inc.
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-06-15
Substance: POVIDONE-IODINE
Active strength: .05 mg/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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: Betadine Gargle
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
POVIDONE-IODINE	.05 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
314935	Internal RxNorm lookup
2374363	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
5f0a3377-1398-2603-c632-f0d214bb88ec	Available on FDA.report

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67618-181-08	ML - Milliliter	67618-181	5e11792d-685d-4c2a-bfe5-3322046bd288	1	2021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67618-181	BETADINE GARGLE (POVIDONE-IODINE) SOLUTION [ATLANTIS CONSUMER HEALTHCARE, INC.]	9	Current NDC, Legacy NDC	20250108_5f0a3377-1398-2603-c632-f0d214bb88ec.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 17 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
WALMART SALINE	SALINE NASAL (SODIUM CHLORIDE)	WALMART STORES INC	06906744-49a5-4bab-8539-af2d235df9e8	2025-10-28	Warnings	Exact identifier application number: M022
Saline	NASAL	PUBLIX SUPER MARKETS, INC	19841567-9511-43d6-ba4e-d1e1bd3481a4	2025-10-28	Warnings	Exact identifier application number: M022
PUBLIX Sore Throat Fast Relief Oral Anesthetic	PHENOL	PUBLIX SUPER MARKETS, INC	89291f12-bbc3-4472-8ad3-a34485af72c9	2025-10-28	Warnings	Exact identifier application number: M022
PUBLIX Sore Throat Menthol Flavor	PHENOL	PUBLIX SUPER MARKETS, INC	9296c49e-557c-43ed-9527-fcba5093a8dc	2025-10-28	Warnings	Exact identifier application number: M022
WinCo Foods Maximum Strength Oral Analgesic	BENZOCAINE	WinCo Foods, LLC	c22a7726-8c3f-41bf-b852-8456b2be6f93	2025-10-28	Warnings	Exact identifier application number: M022
Rugby Cherry Flavor	PHENOL	RUGBY LABORATORIES	3d668c78-8130-45d4-bcb7-dddcb2fbe7a3	2025-10-25	Warnings	Exact identifier application number: M022
LolliCaine Bubble Gum	BENZOCAINE	Centrix, Inc.	56ae3a84-6bca-4906-a03d-9d755e1fba3b	2025-10-24	Warnings	Exact identifier application number: M022
Diabetic Tussin Sore Throat Cherry	PHENOL	MEDTECH PRODUCTS INC	ab351229-5771-4c6c-92a8-721cc41c002f	2025-10-23	Warnings	Exact identifier application number: M022
Chloraseptic Total Sore Throat and Cough, Sugar Free	MENTHOL AND BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE	Prestige Brands Holdings, Inc.	34e4234c-ed61-4795-99fe-d281cdb0af88	2025-10-23	Warnings	Exact identifier application number: M022
Chloraseptic Total Sore Throat and Cough	MENTHOL AND BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE	Prestige Brands Holdings, Inc.	6b1a50d0-be54-4fcb-b5e2-b47abf3555c0	2025-10-23	Warnings	Exact identifier application number: M022
Chloraseptic Childrens Sore Throat Cherry	PHENOL	Prestige Brands Holdings, Inc.	38ff6922-1abe-4fa9-a74e-ede604f707b5	2025-10-23	Warnings	Exact identifier application number: M022
Boka Sensitive	POTASSIUM NITRATE	Karaka LLC	40be9fab-53db-c67a-e063-6394a90a48cb	2025-10-23	Warnings	Exact identifier application number: M022
Canker Care Plus	MENTHOL, UNSPECIFIED FORM	Quantum, Inc.	1ec960db-52d5-4d99-a7f7-a2e538d28724	2025-10-20	Warnings	Exact identifier application number: M022
meijer Sensitive EXTRA WHITENING	POTASSIUM NITRATE, SODIUM FLUORIDE	Meijer, Inc.	bbcffb88-0bd4-4883-bb83-0b7a1428ad12	2025-10-20	Warnings	Exact identifier application number: M022
Quality Choice Maximum Strength Oral Pain Relieving	BENZOCAINE	Chain Drug Marketing Association Inc	dbde8e7f-85d8-4083-b01a-3a7e410a7747	2025-10-17	Warnings	Exact identifier application number: M022
Quality Choice	BENZOCAINE	Chain Drug Marketing Association, Inc.	24c3c4a3-bd76-198d-e063-6394a90ad45a	2025-10-16	Warnings	Exact identifier application number: M022
Sore Throat Relief Cherry Flavor	PHENOL	Cardinal Health	b84203bd-23e9-427d-83d8-f4c88266e23c	2025-10-14	Warnings	Exact identifier application number: M022
Finafta	BENZOCAINE, GLYCERIN	Efficient Laboratories Inc.	03368603-3e11-c2fa-e063-6294a90a04ea	2025-10-14	Warnings	Exact identifier application number: M022
Sensodyne Pronamel Clinical Enamel Strength Whitening Action	POTASSIUM NITRATE, SODIUM FLUORIDE	Haleon US Holdings LLC	e8a62f24-1db6-45fb-b6e1-5e57103f82bc	2025-10-14	Warnings	Exact identifier application number: M022
evo SENSITIVE ANTI-CAVITY FLUORIDE SWEET MINT	POTASSIUM NITRATE, SODIUM FLUORIDE	Ashtel Studios, Inc.	bc74d2a6-fe34-44cf-b015-70ed4d47c933	2025-10-13	Warnings	Exact identifier application number: M022

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
2374363	Betadine 0.5 % Mouthwash	PSN	5f0a3377-1398-2603-c632-f0d214bb88ec	10
314935	povidone-iodine 0.5 % Mouthwash	PSN	5f0a3377-1398-2603-c632-f0d214bb88ec	10
2374363	povidone-iodine 5 MG/ML Mouthwash [Betadine]	SBD	5f0a3377-1398-2603-c632-f0d214bb88ec	10
314935	povidone-iodine 5 MG/ML Mouthwash	SCD	5f0a3377-1398-2603-c632-f0d214bb88ec	10
2374363	Betadine 0.5 % Mouthwash	SY	5f0a3377-1398-2603-c632-f0d214bb88ec	10
2374363	Betadine 5 MG/ML Mouthwash	SY	5f0a3377-1398-2603-c632-f0d214bb88ec	10
314935	povidone-iodine 0.5 % Mouthwash	SY	5f0a3377-1398-2603-c632-f0d214bb88ec	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67618-181-08	67618018108	1 BOTTLE in 1 CARTON (67618-181-08) / 237 mL in 1 BOTTLE	1 bottle	2020-06-15	0000-00-00	No	No	Current
67618-181-16	67618018116	2 BOTTLE in 1 PACKAGE (67618-181-16) / 237 mL in 1 BOTTLE	2 bottle	2023-12-28		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BETADINE® Sore Throat Gargle 0.5% Povidone-iodine	Atlantis Consumer Healthcare, Inc.	2026-01-21	HUMAN OTC DRUG LABEL	10