Maximum Strength Betadine Clear

Product NDC: 67618-183
11-digit product format: 676180183
Labeler code: 67618
Product ID: 67618-183_074e0e6b-8391-4541-b628-bd74a5e7c29c
Type: HUMAN OTC DRUG
Nonproprietary name: Benzalkonium Cl and Pramoxine HCl
Dosage form: SPRAY
Route: TOPICAL
Labeler: Atlantis Consumer Healthcare, Inc.
Application: M003
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-12-22
Substance: BENZALKONIUM CHLORIDE; PRAMOXINE HYDROCHLORIDE
Active strength: .13; 1 mg/mL; 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: Maximum Strength Betadine Clear
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZALKONIUM CHLORIDE	.13 mg/mL
PRAMOXINE HYDROCHLORIDE	1 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
F5UM2KM3W7	Internal UNII lookup
88AYB867L5	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
31b94a76-1536-47c0-ab03-e487c2625c58	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67618-183-06	Maximum Strength Betadine Clear	177 mL in 1 BOTTLE	SPRAY	177		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67618-183	MAXIMUM STRENGTH BETADINE CLEAR (BENZALKONIUM CL AND PRAMOXINE HCL) SPRAY [ATLANTIS CONSUMER HEALTHCARE, INC.]	1	Current NDC, 1 package rows	20240111_31b94a76-1536-47c0-ab03-e487c2625c58.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 3 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Biopure Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	5a4ac18e-8ba5-bef6-e063-6394a90a8811	2026-08-31	Warnings	Exact identifier application number: M003
Biopure Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	5a4d11fa-3f65-b41f-e063-6394a90a30ae	2026-08-31	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer,2pk -Gingerbread and Cherry Cobbler	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	5a52731b-5e8c-5ae6-e063-6394a90a8b04	2026-08-31	Warnings	Exact identifier application number: M003
70% Isopropyl Alcohol	ISOPROPYL ALCOHOL	UpLift Brands, LLC	8ae12375-3a95-475c-9600-17c51a9103f7	2026-08-31	Warnings, Adverse reactions	Exact identifier application number: M003
hydrating mist hand sanitizer with silicone keychain holder - beaver nuggets	ALCOHOL	Ganzhou Olivee Cosmetic Co., Ltd.	f875e065-7b3e-45dc-8a33-b893ab830695	2026-08-31	Warnings	Exact identifier application number: M003
hydrating mist hand sanitizer with silicone keychain holder - signature scent	ALCOHOL	Ganzhou Olivee Cosmetic Co., Ltd.	30e11bf0-1a21-45b1-adf9-cf3845419a98	2026-08-31	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer(Oval Shape)with Beaded Wristlet - Cherry Blossom	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	5a4fb4b6-ba9e-5b82-e063-6294a90a4734	2026-08-30	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer with Woven Lanyard and Chainendants- Watermelon	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	5a503581-061b-0050-e063-6294a90af48a	2026-08-30	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer,2pk-Christmas Rose and Candy Cane	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	5a50402b-e4d7-3c0b-e063-6394a90a5e52	2026-08-30	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer,2pk -Bourbon Peacan and Mistletoe	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	5a508fad-c7a4-82e8-e063-6294a90a0de1	2026-08-30	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer with Beaded Wristlet - Espresso	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	59f160d3-7e42-ef07-e063-6394a90a6f8f	2026-08-29	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer,4pk with Silicone Case,Cherry Blossom /Gardenia /Lavender Vanilla/ Coconut Honey	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	5a2ab646-2dba-5111-e063-6394a90acc4f	2026-08-29	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer,2pk with Woven Lanyard and Charms - Strawberry Dream/ Berry Bliss	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	5a2b50a2-6ee2-04d4-e063-6294a90a1c65	2026-08-29	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer,2pk with Woven Lanyard and Charms - Cherry and Honey Vanilla	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	5a2c11e6-a105-5362-e063-6394a90a132f	2026-08-29	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer with Glitter Silicone Case,2pk Vanilla Chai and Espresso	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	59ef14d6-1a40-ea3c-e063-6394a90af442	2026-08-28	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer with Glitter Silicone Case , 2pk Champagne Toast and Sparkling Pomegranate	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	597530cb-03f6-b72d-e063-6394a90a0d6c	2026-08-28	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer,4pk with Silicone Case,Rosewater/Raspberry Fizz/Strawberry Vanilla/Pink Peony	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	59f1521c-ad5c-e2d6-e063-6394a90a4e2b	2026-08-28	Warnings	Exact identifier application number: M003
Smart Care Hand Sanitizer,2pk with Woven Lanyard and Charms - Sparkling Watermelon/ Pomegranate Raspberry	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	5a2a89f4-838e-e3ea-e063-6294a90a1ac2	2026-08-27	Warnings	Exact identifier application number: M003
Biopure Antibacterial Hand Wipe	ANTIBACTERIAL HAND WIPE	Fujian Yifa Healthcare Products Co., Ltd.	59ed87d5-dab1-abab-e063-6394a90a024d	2026-08-26	Warnings	Exact identifier application number: M003
Povidone Iodine Swabstick	POVIDONE IODINE 10%	Trifecta Pharmaceuticals USA LLC	59f82f9d-8c39-6890-e063-6294a90a090e	2026-08-26	Warnings	Exact identifier application number: M003

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F5UM2KM3W7	BENZALKONIUM CHLORIDE	8001-54-5	BENZALKONIUM CHLORIDE
88AYB867L5	PRAMOXINE HYDROCHLORIDE	637-58-1	PRAMOXINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67618-183-06	67618018306	177 mL in 1 BOTTLE (67618-183-06)	177 ml	2023-12-22	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MAXIMUM STRENGTH BETADINE CLEAR SPRAY	Atlantis Consumer Healthcare, Inc.	2026-08-31	HUMAN OTC DRUG LABEL	3