Smile Direct Club

Product NDC: 73333-125
11-digit product format: 733330125
Labeler code: 73333
Product ID: 73333-125_9c48abe5-93ca-2418-e053-2995a90a8386
Type: HUMAN OTC DRUG
Nonproprietary name: Sodium Fluoride Toothpaste
Dosage form: PASTE, DENTIFRICE
Route: ORAL
Labeler: Nutrix International, LLC
Application: part355
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2019-09-25
Marketing end: 0000-00-00
Substance: SODIUM FLUORIDE
Active strength: 2 mg/g
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	73333-125		I	Inactivated by FDA	2026-10-12
excluded product	product	73333-125		I	Inactivated by FDA	2026-10-12
excluded product	product	73333-125		I	Inactivated by FDA	2026-10-12
excluded package	package	73333-125	73333-125-01	I	Inactivated by FDA	2026-10-12
excluded package	package	73333-125	73333-125-02	I	Inactivated by FDA	2026-10-12
excluded package	package	73333-125	73333-125-03	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 2 · 110 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 product	product		`d630ba8d3edf…`	`732f749b63fb…`
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	73333-125-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	73333-125-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	73333-125-01	`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 product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
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	73333-125-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	73333-125-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	73333-125-01	`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 product	product		`2ef7874e63bc…`	`57b86245f4fa…`
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	73333-125-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	73333-125-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	73333-125-01	`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 product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
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	73333-125-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	73333-125-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	73333-125-01	`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 product	product		`cfe11265f3b6…`	`090c488252e2…`
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	73333-125-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	73333-125-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	73333-125-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	73333-125-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	73333-125-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	73333-125-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	73333-125-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	73333-125-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	73333-125-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	73333-125-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	73333-125-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	73333-125-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	73333-125-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	73333-125-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	73333-125-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	73333-125-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	73333-125-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	73333-125-01	`ad56d346431e…`	`cc804d4bbf1e…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
73333-125-02	2022-01-28	C162847	48780-1	d6a99b39-d307-a426-e053-dadaa90af4c2	9c48a724-8014-2470-e053-2995a90a6365
73333-125-03	2022-01-28	C162847	48780-1	d6a99b39-ece2-a426-e053-dadaa90af4c2	9c49666c-3437-47e6-e053-2a95a90ad7a5
73333-125-01	2021-01-29	C162847	48780-1	ba0f9c33-3e7f-a910-e053-dadaa90a0b85	936893e2-518e-5139-e053-2a95a90a076c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
73333-125-03	Smile Direct Club	125 g in 1 TUBE	PASTE, DENTIFRICE	125	3
73333-125-03	Smile Direct Club	1 in 1 CARTON	PASTE, DENTIFRICE	1	3
73333-125-02	Smile Direct Club	125 g in 1 TUBE	PASTE, DENTIFRICE	125	2
73333-125-02	Smile Direct Club	1 in 1 CARTON	PASTE, DENTIFRICE	1	2
73333-125-01	Smile Direct Club	1 in 1 CARTON	PASTE, DENTIFRICE	1	1
73333-125-01	Smile Direct Club	125 g in 1 TUBE	PASTE, DENTIFRICE	125	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73333-125	SMILE DIRECT CLUB (SODIUM FLUORIDE TOOTHPASTE) PASTE, DENTIFRICE [NUTRIX INTERNATIONAL, LLC]	3	Legacy NDC, 2 package rows	20200117_9c49666c-3437-47e6-e053-2a95a90ad7a5.zip
73333-125	SMILE DIRECT CLUB (SODIUM FLUORIDE TOOTHPASTE) PASTE, DENTIFRICE [NUTRIX INTERNATIONAL, LLC]	2	Legacy NDC, 2 package rows	20200117_9c48a724-8014-2470-e053-2995a90a6365.zip
73333-125	SMILE DIRECT CLUB (SODIUM FLUORIDE TOOTHPASTE) PASTE, DENTIFRICE [NUTRIX, LLC]	1	Legacy NDC, 2 package rows	20191123_936893e2-518e-5139-e053-2a95a90a076c.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
891775	sodium fluoride 0.243 % Toothpaste	PSN	9c49666c-3437-47e6-e053-2a95a90ad7a5	3
891775	sodium fluoride 0.00243 MG/MG Toothpaste	SCD	9c49666c-3437-47e6-e053-2a95a90ad7a5	3
891775	sodium fluoride 0.243 % (fluoride ion 0.13 % ) Toothpaste	SY	9c49666c-3437-47e6-e053-2a95a90ad7a5	3
891775	sodium fluoride 0.243 % (fluoride ion 0.14 % ) Toothpaste	SY	9c49666c-3437-47e6-e053-2a95a90ad7a5	3
891775	sodium fluoride 0.243 % (fluoride ion 0.15 % ) Toothpaste	SY	9c49666c-3437-47e6-e053-2a95a90ad7a5	3
891775	sodium fluoride 0.243 % (fluoride ion 0.16 % ) Toothpaste	SY	9c49666c-3437-47e6-e053-2a95a90ad7a5	3
891775	sodium fluoride 0.243 % Toothpaste	PSN	9c48a724-8014-2470-e053-2995a90a6365	2
891775	sodium fluoride 0.00243 MG/MG Toothpaste	SCD	9c48a724-8014-2470-e053-2995a90a6365	2
891775	sodium fluoride 0.243 % (fluoride ion 0.13 % ) Toothpaste	SY	9c48a724-8014-2470-e053-2995a90a6365	2
891775	sodium fluoride 0.243 % (fluoride ion 0.14 % ) Toothpaste	SY	9c48a724-8014-2470-e053-2995a90a6365	2
891775	sodium fluoride 0.243 % (fluoride ion 0.15 % ) Toothpaste	SY	9c48a724-8014-2470-e053-2995a90a6365	2
891775	sodium fluoride 0.243 % (fluoride ion 0.16 % ) Toothpaste	SY	9c48a724-8014-2470-e053-2995a90a6365	2
891775	sodium fluoride 0.243 % Toothpaste	PSN	936893e2-518e-5139-e053-2a95a90a076c	1
891775	sodium fluoride 0.00243 MG/MG Toothpaste	SCD	936893e2-518e-5139-e053-2a95a90a076c	1
891775	sodium fluoride 0.243 % (fluoride ion 0.13 % ) Toothpaste	SY	936893e2-518e-5139-e053-2a95a90a076c	1
891775	sodium fluoride 0.243 % (fluoride ion 0.14 % ) Toothpaste	SY	936893e2-518e-5139-e053-2a95a90a076c	1
891775	sodium fluoride 0.243 % (fluoride ion 0.15 % ) Toothpaste	SY	936893e2-518e-5139-e053-2a95a90a076c	1
891775	sodium fluoride 0.243 % (fluoride ion 0.16 % ) Toothpaste	SY	936893e2-518e-5139-e053-2a95a90a076c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
73333-125-01	73333012501	1 in 1 CARTON						Historical
73333-125-02	73333012502	1 TUBE in 1 CARTON (73333-125-02) > 125 g in 1 TUBE	1 tube	2019-09-25	0000-00-00	No	No	Current
73333-125-03	73333012503	1 TUBE in 1 CARTON (73333-125-03) > 125 g in 1 TUBE	1 tube	2019-09-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Smile Direct Club - Nutrix International, LLC \| Nutrix International,LLC	Nutrix International, LLC \| Nutrix International,LLC	2020-01-16	HUMAN OTC DRUG LABEL	3
Smile Direct Club - Nutrix International, LLC \| Nutrix,LLC	Nutrix International, LLC \| Nutrix,LLC	2020-01-16	HUMAN OTC DRUG LABEL	2
Smile Direct Club - Nutrix, LLC \| Nutrix,LLC	Nutrix, LLC \| Nutrix,LLC	2019-09-25	HUMAN OTC DRUG LABEL	1