AQUAFRESH

Product NDC: 0135-0605
Requested package NDC: 0135-0605-01
11-digit product format: 001350605
Labeler code: 0135
Product ID: 0135-0605_0e988328-62da-43e7-98b3-5d94a4cd6684
Type: HUMAN OTC DRUG
Nonproprietary name: potassium nitrate and sodium fluoride
Dosage form: PASTE
Route: DENTAL
Labeler: Haleon US Holdings LLC
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2017-02-17
Substance: POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength: 50; 1.1 mg/g; mg/g
NDC exclude flag: No
Listing certified through: 2026-12-31
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: AQUAFRESH
Brand name suffix: SENSITIVE MAXIMUM STRENGTH
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
POTASSIUM NITRATE	50 mg/g
SODIUM FLUORIDE	1.1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
RU45X2JN0Z	Internal UNII lookup
8ZYQ1474W7	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1038929	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
76adbccb-0812-4407-a6fc-a57e6f144fbb	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0135-0605-01	AQUAFRESHSENSITIVE MAXIMUM STRENGTH	158.8 g in 1 TUBE	PASTE	158.8		13
0135-0605-01	AQUAFRESHSENSITIVE MAXIMUM STRENGTH	1 in 1 CARTON	PASTE	1		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0135-0605-01	GM - Gram	0135-0605	9ab66894-b0d9-476f-9512-d5dce913cf6a	1	2021-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
POTASSIUM NITRATE	ACTIVE INGREDIENT	RU45X2JN0Z	AQUAFRESH SENSITIVE MAXIMUM STRENGTH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	5
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	AQUAFRESH SENSITIVE MAXIMUM STRENGTH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	5
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	AQUAFRESH SENSITIVE MAXIMUM STRENGTH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	5
NITRATE ION	ACTIVE MOIETY	T93E9Y2844	AQUAFRESH SENSITIVE MAXIMUM STRENGTH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	5
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	AQUAFRESH SENSITIVE MAXIMUM STRENGTH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	5
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	AQUAFRESH SENSITIVE MAXIMUM STRENGTH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	5
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	AQUAFRESH SENSITIVE MAXIMUM STRENGTH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	5
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	AQUAFRESH SENSITIVE MAXIMUM STRENGTH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	5
HYDRATED SILICA	INACTIVE INGREDIENT	Y6O7T4G8P9	AQUAFRESH SENSITIVE MAXIMUM STRENGTH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	5
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	AQUAFRESH SENSITIVE MAXIMUM STRENGTH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	5
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	AQUAFRESH SENSITIVE MAXIMUM STRENGTH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	5
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	AQUAFRESH SENSITIVE MAXIMUM STRENGTH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	5
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	AQUAFRESH SENSITIVE MAXIMUM STRENGTH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	5
SORBITOL	INACTIVE INGREDIENT	506T60A25R	AQUAFRESH SENSITIVE MAXIMUM STRENGTH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AQUAFRESH SENSITIVE MAXIMUM STRENGTH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	AQUAFRESH SENSITIVE MAXIMUM STRENGTH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	5
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	AQUAFRESH SENSITIVE MAXIMUM STRENGTH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0135-0605	AQUAFRESH SENSITIVE MAXIMUM STRENGTH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC]	13	Current NDC, Legacy NDC, 2 package rows	20240307_76adbccb-0812-4407-a6fc-a57e6f144fbb.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 39 of 40 · 782 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oral Pain Relief	BENZOCAINE	GERI-CARE PHARMACEUTICAL CORP	d294a39e-55f4-272d-e053-2995a90ab7f7	2023-10-31	Warnings	Exact identifier application number: M022
Avant	BENZOCAINE	Dharma Research, Inc.	e10c45e6-d37f-4650-b3e5-07719cc0ea49	2023-10-11	Warnings	Exact identifier application number: M022
Avant	BENZOCAINE	Dharma Research, Inc.	886d949b-8db1-499c-a277-174f8bc29f34	2023-10-11	Warnings	Exact identifier application number: M022
Avant	BENZOCAINE	Dharma Research, Inc.	fc8194af-2e77-4ad1-ae75-461dce3ed604	2023-10-11	Warnings	Exact identifier application number: M022
Avant	BENZOCAINE	Dharma Research, Inc.	baf7d184-07ed-4491-a1fc-9a377b4b0110	2023-10-11	Warnings	Exact identifier application number: M022
Avant	BENZOCAINE	Dharma Research, Inc.	033034af-c86c-4dbf-90eb-009c117024c6	2023-10-11	Warnings	Exact identifier application number: M022
Avant	BENZOCAINE	Dharma Research, Inc.	658ada18-2334-4b4e-b08e-702fa127aa14	2023-10-11	Warnings	Exact identifier application number: M022
Avant	BENZOCAINE	Dharma Research, Inc.	cad932e5-8d7f-4f20-b1c2-febd328152f0	2023-10-11	Warnings	Exact identifier application number: M022
Iolite	BENZOCAINE	Dharma Research, Inc.	2c9519ab-320d-49da-9deb-97a6168fb088	2023-10-10	Warnings	Exact identifier application number: M022
Ioline	BENZOCAINE	Dharma Research, Inc.	b862c974-c024-42c3-986e-b65069437c7b	2023-10-10	Warnings	Exact identifier application number: M022
Iolite	BENZOCAINE	Dharma Research, Inc.	651ea978-081d-4c59-b177-6049a69d9415	2023-10-10	Warnings	Exact identifier application number: M022
Iolite	BENZOCAINE	Dharma Research, Inc.	db763237-2910-45b9-be72-da092edc951b	2023-10-10	Warnings	Exact identifier application number: M022
Iolite	BENZOCAINE	Dharma Research, Inc.	34316f93-10b4-41cc-8654-625283f0044c	2023-10-10	Warnings	Exact identifier application number: M022
Iolite	BENZOCAINE	Dharma Research, Inc.	142a8824-657e-492a-8e5a-b15eb73383c9	2023-10-10	Warnings	Exact identifier application number: M022
Iolite	BENZOCAINE	Dharma Research, Inc.	414cbec9-94e2-4bca-908b-1e79f8db0b27	2023-10-10	Warnings	Exact identifier application number: M022
Sore throat cherry	PHENOL	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	de634cf1-ed39-4d8a-8855-006c69b7aee9	2023-10-10	Warnings	Exact identifier application number: M022
Iolite	BENZOCAINE	Dharma Research, Inc.	e4b2d22b-00b3-45a6-9b7d-8ee719587059	2023-10-09	Warnings	Exact identifier application number: M022
Iolite	BENZOCAINE	Dharma Research, Inc.	a0e284f6-292f-4231-8596-f7cee4e0a12f	2023-10-09	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	fe92637a-c88a-f9dd-e053-6294a90a7fa3	2023-07-01	Warnings	Exact identifier application number: M022
HurriCaine Topical Anesthetic	BENZOCAINE	Beutlich Pharmaceuticals, LLC	c979e958-2042-471a-bf03-e84e68620106	2023-06-20	Warnings	Exact identifier application number: M022

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
RU45X2JN0Z	POTASSIUM NITRATE	7757-79-1	POTASSIUM NITRATE
8ZYQ1474W7	SODIUM FLUORIDE	7681-49-4	SODIUM FLUORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste	PSN	76adbccb-0812-4407-a6fc-a57e6f144fbb	13
1038929	potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG Toothpaste	SCD	76adbccb-0812-4407-a6fc-a57e6f144fbb	13
1038929	K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste	SY	76adbccb-0812-4407-a6fc-a57e6f144fbb	13
1038929	Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste	SY	76adbccb-0812-4407-a6fc-a57e6f144fbb	13
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste	SY	76adbccb-0812-4407-a6fc-a57e6f144fbb	13
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste	SY	76adbccb-0812-4407-a6fc-a57e6f144fbb	13
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste	SY	76adbccb-0812-4407-a6fc-a57e6f144fbb	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0135-0605-01	00135060501	1 TUBE in 1 CARTON (0135-0605-01) / 158.8 g in 1 TUBE	1 tube	2017-02-17	0000-00-00	No	No	Current