Rain Breeze Toothpaste

Product NDC: 51289-100
11-digit product format: 512890100
Labeler code: 51289
Product ID: 51289-100_728deb34-df4e-44f6-b9b7-4c4f4968ee40
Type: HUMAN OTC DRUG
Nonproprietary name: SODIUM FLUORIDE
Dosage form: PASTE
Route: DENTAL
Labeler: Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd.
Application: part355
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2010-08-21
Marketing end: 0000-00-00
Substance: SODIUM FLUORIDE
Active strength: 0 g/100g
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 14 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	51289-100		I	Inactivated by FDA	2026-10-12
excluded package	package	51289-100	51289-100-01	I	Inactivated by FDA	2026-10-12
excluded package	package	51289-100	51289-100-02	I	Inactivated by FDA	2026-10-12
excluded package	package	51289-100	51289-100-03	I	Inactivated by FDA	2026-10-12
excluded package	package	51289-100	51289-100-04	I	Inactivated by FDA	2026-10-12
excluded package	package	51289-100	51289-100-05	I	Inactivated by FDA	2026-10-12
excluded package	package	51289-100	51289-100-06	I	Inactivated by FDA	2026-10-12
excluded package	package	51289-100	51289-100-07	I	Inactivated by FDA	2026-10-12
excluded package	package	51289-100	51289-100-08	I	Inactivated by FDA	2026-10-12
excluded package	package	51289-100	51289-100-09	I	Inactivated by FDA	2026-10-12
excluded package	package	51289-100	51289-100-10	I	Inactivated by FDA	2026-10-12
excluded package	package	51289-100	51289-100-11	I	Inactivated by FDA	2026-10-12
excluded package	package	51289-100	51289-100-12	I	Inactivated by FDA	2026-10-12
excluded package	package	51289-100	51289-100-13	I	Inactivated by FDA	2026-10-12

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 6 · 308 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51289-100-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51289-100-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51289-100-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51289-100-13	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51289-100-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51289-100-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51289-100-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51289-100-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51289-100-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51289-100-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51289-100-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51289-100-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51289-100-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51289-100-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51289-100-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51289-100-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51289-100-13	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51289-100-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51289-100-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51289-100-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51289-100-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51289-100-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51289-100-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51289-100-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51289-100-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51289-100-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51289-100-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51289-100-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51289-100-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51289-100-13	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51289-100-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51289-100-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51289-100-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51289-100-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51289-100-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51289-100-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51289-100-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51289-100-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	51289-100-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51289-100-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51289-100-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51289-100-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51289-100-13	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51289-100-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51289-100-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51289-100-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51289-100-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51289-100-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51289-100-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51289-100-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51289-100-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	51289-100-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51289-100-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51289-100-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	51289-100-10	`cfe11265f3b6…`	`090c488252e2…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
51289-100-01	TOOTHPASTE DRUG FACTS
51289-100-02	TOOTHPASTE DRUG FACTS
51289-100-03	TOOTHPASTE DRUG FACTS
51289-100-04	TOOTHPASTE DRUG FACTS
51289-100-05	TOOTHPASTE DRUG FACTS
51289-100-06	TOOTHPASTE DRUG FACTS
51289-100-07	TOOTHPASTE DRUG FACTS
51289-100-08	TOOTHPASTE DRUG FACTS
51289-100-09	TOOTHPASTE DRUG FACTS
51289-100-10	TOOTHPASTE DRUG FACTS
51289-100-11	TOOTHPASTE DRUG FACTS
51289-100-12	TOOTHPASTE DRUG FACTS
51289-100-13	TOOTHPASTE DRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51289-100-01	Rain Breeze Toothpaste	17 g in 1 TUBE	PASTE	17	3
51289-100-02	Rain Breeze Toothpaste	24 g in 1 TUBE	PASTE	24	3
51289-100-03	Rain Breeze Toothpaste	35 g in 1 TUBE	PASTE	35	3
51289-100-04	Rain Breeze Toothpaste	43 g in 1 TUBE	PASTE	43	3
51289-100-05	Rain Breeze Toothpaste	50 g in 1 TUBE	PASTE	50	3
51289-100-06	Rain Breeze Toothpaste	70 g in 1 TUBE	PASTE	70	3
51289-100-07	Rain Breeze Toothpaste	78 g in 1 TUBE	PASTE	78	3
51289-100-08	Rain Breeze Toothpaste	90 g in 1 TUBE	PASTE	90	3
51289-100-09	Rain Breeze Toothpaste	100 g in 1 TUBE	PASTE	100	3
51289-100-10	Rain Breeze Toothpaste	120 g in 1 TUBE	PASTE	120	3
51289-100-11	Rain Breeze Toothpaste	130 g in 1 TUBE	PASTE	130	3
51289-100-12	Rain Breeze Toothpaste	150 g in 1 TUBE	PASTE	150	3
51289-100-13	Rain Breeze Toothpaste	180 g in 1 TUBE	PASTE	180	3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SODIUM FLUORIDE	ACTIVE INGREDIENT	8ZYQ1474W7	RAIN BREEZE TOOTHPASTE (SODIUM FLUORIDE) PASTE [YANGZHOU HENGYUAN DAILY CHEMICAL PLASTIC CO., LTD.]	3
Fluoride Ion	ACTIVE MOIETY	Q80VPU408O	RAIN BREEZE TOOTHPASTE (SODIUM FLUORIDE) PASTE [YANGZHOU HENGYUAN DAILY CHEMICAL PLASTIC CO., LTD.]	3
CARBOXYMETHYLCELLULOSE SODIUM	INACTIVE INGREDIENT	K679OBS311	RAIN BREEZE TOOTHPASTE (SODIUM FLUORIDE) PASTE [YANGZHOU HENGYUAN DAILY CHEMICAL PLASTIC CO., LTD.]	3
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	RAIN BREEZE TOOTHPASTE (SODIUM FLUORIDE) PASTE [YANGZHOU HENGYUAN DAILY CHEMICAL PLASTIC CO., LTD.]	3
PROPYLPARABEN SODIUM	INACTIVE INGREDIENT	625NNB0G9N	RAIN BREEZE TOOTHPASTE (SODIUM FLUORIDE) PASTE [YANGZHOU HENGYUAN DAILY CHEMICAL PLASTIC CO., LTD.]	3
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	RAIN BREEZE TOOTHPASTE (SODIUM FLUORIDE) PASTE [YANGZHOU HENGYUAN DAILY CHEMICAL PLASTIC CO., LTD.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	RAIN BREEZE TOOTHPASTE (SODIUM FLUORIDE) PASTE [YANGZHOU HENGYUAN DAILY CHEMICAL PLASTIC CO., LTD.]	3
Sodium Lauryl Sulfate	INACTIVE INGREDIENT	368GB5141J	RAIN BREEZE TOOTHPASTE (SODIUM FLUORIDE) PASTE [YANGZHOU HENGYUAN DAILY CHEMICAL PLASTIC CO., LTD.]	3
Sorbitol	INACTIVE INGREDIENT	506T60A25R	RAIN BREEZE TOOTHPASTE (SODIUM FLUORIDE) PASTE [YANGZHOU HENGYUAN DAILY CHEMICAL PLASTIC CO., LTD.]	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	RAIN BREEZE TOOTHPASTE (SODIUM FLUORIDE) PASTE [YANGZHOU HENGYUAN DAILY CHEMICAL PLASTIC CO., LTD.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51289-100	RAIN BREEZE TOOTHPASTE (SODIUM FLUORIDE) PASTE [YANGZHOU HENGYUAN DAILY CHEMICAL PLASTIC CO., LTD.]	3	Legacy NDC, 13 package rows	20100909_6265ffa0-2756-41f5-bce8-c1fd81676bae.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8ZYQ1474W7	SODIUM FLUORIDE	7681-49-4	SODIUM FLUORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
245598	sodium fluoride 0.22 % Toothpaste	PSN	6265ffa0-2756-41f5-bce8-c1fd81676bae	3
245598	sodium fluoride 0.0022 MG/MG Toothpaste	SCD	6265ffa0-2756-41f5-bce8-c1fd81676bae	3
245598	sodium fluoride 0.22 % (fluoride 0.1 % ) Toothpaste	SY	6265ffa0-2756-41f5-bce8-c1fd81676bae	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
51289-100-01	51289010001	17 g in 1 TUBE	17 g	Historical
51289-100-02	51289010002	24 g in 1 TUBE	24 g	Historical
51289-100-03	51289010003	35 g in 1 TUBE	35 g	Historical
51289-100-04	51289010004	43 g in 1 TUBE	43 g	Historical
51289-100-05	51289010005	50 g in 1 TUBE	50 g	Historical
51289-100-06	51289010006	70 g in 1 TUBE	70 g	Historical
51289-100-07	51289010007	78 g in 1 TUBE	78 g	Historical
51289-100-08	51289010008	90 g in 1 TUBE	90 g	Historical
51289-100-09	51289010009	100 g in 1 TUBE	100 g	Historical
51289-100-10	51289010010	120 g in 1 TUBE	120 g	Historical
51289-100-11	51289010011	130 g in 1 TUBE	130 g	Historical
51289-100-12	51289010012	150 g in 1 TUBE	150 g	Historical
51289-100-13	51289010013	180 g in 1 TUBE	180 g	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TOOTHPASTE DRUG FACTS	Yangzhou Hengyuan Daily Chemical Plastic Co., Ltd.	2010-08-26	HUMAN OTC DRUG LABEL	3