Early Bird Wintergreen and Peppermint

Product NDC: 72164-001
11-digit product format: 721640001
Labeler code: 72164
Product ID: 72164-001_ebe7cc38-e054-1d14-e053-2a95a90aad8f
Type: HUMAN OTC DRUG
Nonproprietary name: POTASSIUM NITRATE, SODIUM FLUORIDE
Dosage form: PASTE
Route: DENTAL
Labeler: Smiletwice, Inc.
Application: part356
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2018-05-18
Marketing end: 0000-00-00
Substance: POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength: 50 mg/g; mg/g
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	72164-001		I	Inactivated by FDA	2026-10-05
excluded package	package	72164-001	72164-001-00	D	Discontinued by firm	2026-10-05
excluded package	package	72164-001	72164-001-01	I	Inactivated by FDA	2026-10-05

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 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	72164-001-00	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	72164-001-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	72164-001-00	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	72164-001-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	72164-001-00	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	72164-001-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	72164-001-00	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	72164-001-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	72164-001-00	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	72164-001-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	72164-001-00	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	72164-001-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	72164-001-01	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	72164-001-00	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72164-001-01	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72164-001-00	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72164-001-01	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72164-001-00	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	72164-001-00	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	72164-001-00	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	72164-001-00	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c6f86816-7da6-43ea-8c25-ac9758311cc5	Product name	1	20220118
252e11b6-1a9a-4283-a242-df2c129c496d	Product name	3	20170717
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
72164-001-00	2025-01-30	C162847	48780-1	2cef2736-9d1e-d83d-e063-dadaa90ab31f	Early Bird Wintergreen and Peppermint Toothpaste
72164-001-01	2025-01-30	C162847	48780-1	2cef2736-9d1e-d83d-e063-dadaa90ab31f	Early Bird Wintergreen and Peppermint Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72164-001-00	Early Bird Wintergreen and Peppermint	96 g in 1 TUBE	PASTE	96		6
72164-001-00	Early Bird Wintergreen and Peppermint	2 in 1 BOX	PASTE	2		6
72164-001-01	The Duo	96 g in 1 TUBE	PASTE	96 g	50 mg in 1g	6
72164-001-01	4 Pack	96 g in 1 TUBE	PASTE	192 g	50 mg in 1g	6
72164-001-01	Early Bird Wintergreen and Peppermint	96 g in 1 TUBE	PASTE	96		6
72164-001-02	Mini Duo	23 g in 1 TUBE	PASTE	23 g	50 mg in 1g	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72164-001	4 PACK (POTASSIUM NITRATE, SODIUM FLUORIDE) KIT [SMILETWICE, INC.]	6	Legacy NDC	20231221_c3707c03-3761-4901-89c4-11d214c9287d.zip
72164-001	EARLY BIRD WINTERGREEN AND PEPPERMINT (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE [SMILETWICE, INC.]	6	Legacy NDC, 3 package rows	20221027_10743960-2a60-4a2f-a024-8e3b79b0d118.zip
72164-001	THE DUO (POTASSIUM NITRATE, SODIUM FLUORIDE) KIT [SMILETWICE, INC.]	6	Legacy NDC	20231221_4c10df9f-cc42-41ba-968e-0f4470536e3d.zip
72164-001	MINI DUO (POTASSIUM NITRATE, SODIUM FLUORIDE) KIT [SMILETWICE, INC.]	3	Legacy NDC	20231221_99509d36-cae4-43a7-9ae7-74c101b1bee9.zip

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	10743960-2a60-4a2f-a024-8e3b79b0d118	6
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste	PSN	4c10df9f-cc42-41ba-968e-0f4470536e3d	6
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste	PSN	c3707c03-3761-4901-89c4-11d214c9287d	6
1038929	potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG Toothpaste	SCD	10743960-2a60-4a2f-a024-8e3b79b0d118	6
1038929	potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG Toothpaste	SCD	4c10df9f-cc42-41ba-968e-0f4470536e3d	6
1038929	potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG Toothpaste	SCD	c3707c03-3761-4901-89c4-11d214c9287d	6
1038929	K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste	SY	c3707c03-3761-4901-89c4-11d214c9287d	6
1038929	K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste	SY	10743960-2a60-4a2f-a024-8e3b79b0d118	6
1038929	K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste	SY	4c10df9f-cc42-41ba-968e-0f4470536e3d	6
1038929	Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste	SY	10743960-2a60-4a2f-a024-8e3b79b0d118	6
1038929	Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste	SY	4c10df9f-cc42-41ba-968e-0f4470536e3d	6
1038929	Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste	SY	c3707c03-3761-4901-89c4-11d214c9287d	6
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste	SY	10743960-2a60-4a2f-a024-8e3b79b0d118	6
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste	SY	c3707c03-3761-4901-89c4-11d214c9287d	6
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste	SY	4c10df9f-cc42-41ba-968e-0f4470536e3d	6
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste	SY	4c10df9f-cc42-41ba-968e-0f4470536e3d	6
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste	SY	c3707c03-3761-4901-89c4-11d214c9287d	6
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste	SY	10743960-2a60-4a2f-a024-8e3b79b0d118	6
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste	SY	c3707c03-3761-4901-89c4-11d214c9287d	6
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste	SY	4c10df9f-cc42-41ba-968e-0f4470536e3d	6
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste	SY	10743960-2a60-4a2f-a024-8e3b79b0d118	6
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste	PSN	99509d36-cae4-43a7-9ae7-74c101b1bee9	3
1038929	potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG Toothpaste	SCD	99509d36-cae4-43a7-9ae7-74c101b1bee9	3
1038929	K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste	SY	99509d36-cae4-43a7-9ae7-74c101b1bee9	3
1038929	Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste	SY	99509d36-cae4-43a7-9ae7-74c101b1bee9	3
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste	SY	99509d36-cae4-43a7-9ae7-74c101b1bee9	3
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste	SY	99509d36-cae4-43a7-9ae7-74c101b1bee9	3
1038929	potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste	SY	99509d36-cae4-43a7-9ae7-74c101b1bee9	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72164-001-00	72164000100	96 g in 1 TUBE	96 g					Historical
72164-001-01	72164000101	96 g in 1 TUBE (72164-001-01)	96 g	2018-05-18	0000-00-00	No	No	Current
72164-001-02	72164000102	23 g in 1 TUBE	23 g					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
The Duo	Smiletwice, Inc.	2023-12-21	HUMAN OTC DRUG LABEL	6
4 Pack	Smiletwice, Inc.	2023-12-21	HUMAN OTC DRUG LABEL	6
Mini Toothpaste-Duo KIT	Smiletwice, Inc.	2023-12-21	HUMAN OTC DRUG LABEL	3
Early Bird Wintergreen and Peppermint Toothpaste	Smiletwice, Inc.	2022-10-25	HUMAN OTC DRUG LABEL	6