ATOMY PROPOLIS TOOTHPAS TE 50G

Product NDC: 52257-1380
11-digit product format: 522571380
Labeler code: 52257
Product ID: 52257-1380_bf9632ba-2fdb-4d32-b069-b2533e94f974
Type: HUMAN OTC DRUG
Nonproprietary name: Sodium Monofluorophosphate, Sodium Fluoride
Dosage form: PASTE, DENTIFRICE
Route: ORAL
Labeler: ATOMY CO., LTD.
Application: M021
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-12-01
Substance: SODIUM MONOFLUOROPHOSPHATE; SODIUM FLUORIDE
Active strength: .08; .05 g/50g; g/50g
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: ATOMY PROPOLIS TOOTHPAS TE 50G
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM MONOFLUOROPHOSPHATE	.08 g/50g
SODIUM FLUORIDE	.05 g/50g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
C810JCZ56Q	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
1046867	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
98d839e3-a1aa-c83d-e053-2995a90a7e79	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52257-1380-1	ATOMY PROPOLIS TOOTHPAS TE 50G	50 g in 1 TUBE	PASTE, DENTIFRICE	50		5
52257-1380-2	ATOMY PROPOLIS TOOTHPAS TE 50G	4 in 1 CARTON	PASTE, DENTIFRICE	4		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52257-1380	ATOMY PROPOLIS TOOTHPAS TE 50G (SODIUM MONOFLUOROPHOSPHATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [ATOMY CO., LTD.]	5	Current NDC, Legacy NDC, 2 package rows	20240130_98d839e3-a1aa-c83d-e053-2995a90a7e79.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 47 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dentalclean Blue Diamond Alcohol Free Mouthwash	SODIUM FLUORIDE 0.05%	Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda	1881658c-e371-5513-e063-6394a90a465f	2024-05-15	Warnings	Exact identifier application number: M021
Dentalclean Dr. Duck Strawberry flouride Mouthwash	SODIUM FLUORIDE 0.02%	Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda	1882c82a-3a32-5656-e063-6394a90ae0ed	2024-05-15	Warnings	Exact identifier application number: M021
Dentalclean Booster Kids	SODIUM FLUORIDE 0.24%	Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda	186ecaeb-9401-9315-e063-6394a90a8e20	2024-05-14	Warnings	Exact identifier application number: M021
BIO SPECTRA ATTITUDE	SODIUM FLUORIDE	9055-7588 Qubec Inc. DBA ATTITUDE	fefc1060-e1a4-4686-a8d8-84bf1e613abe	2024-05-14	Warnings	Exact identifier application number: M021
Dentalclean Doctor Duck	SODIUM FLUORIDE 0.24%	Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda	186f2f12-279f-32df-e063-6394a90ad53d	2024-05-14	Warnings	Exact identifier application number: M021
Barbie Bubble Gum ANTICAVITY FLUORIDE	SODIUM FLUORIDE	Ashtel Studios Inc.	dc5489e9-eeff-4db5-8793-21fb5bf4b2ef	2024-05-10	Warnings	Exact identifier application number: M021
Dentalclean Regenerator Sensitive Kids	SODIUM FLUORIDE 0.24%	Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda	17f31b5e-dd3b-78df-e063-6294a90a43ab	2024-05-08	Warnings	Exact identifier application number: M021
Dentalclean Dental Gel Booster Adult Use	SODIUM FLUORIDE 0.24%	Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda	17f3981f-ab4b-0dcd-e063-6294a90a37d9	2024-05-08	Warnings	Exact identifier application number: M021
Dentalclean Sensitive Plus	SODIUM FLUORIDE 0.24%	Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda	17e0dc93-97bf-7f05-e063-6294a90a9a8b	2024-05-07	Warnings	Exact identifier application number: M021
Dentalclean Whitening Max	SODIUM FLUORIDE 0.24%	Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda	17e2364e-2511-3021-e063-6294a90a40e1	2024-05-07	Warnings	Exact identifier application number: M021
DeCure	SODIUM MONOFLUOROPHOSPHATE	Scope medical devices private limited	590c4827-f036-45bd-af30-0a4853ca3447	2024-05-07	Warnings	Exact identifier application number: M021
Gelato Homecare	STANNOUS FLUORIDE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.	07d7fb43-8d3e-4d1f-b38d-e3caf28e9acf	2024-04-22	Warnings	Exact identifier application number: M021
Gelato Homecare	STANNOUS FLUORIDE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.	1e93d4f8-1eec-40f8-8a6d-86e96dfeb8db	2024-04-19	Warnings	Exact identifier application number: M021
Toothpaste, plus Toothbrush	SODIUM FLUORIDE PASTE, DENTIFRICE AND TOOTHBRUSH	Lil' Drug Store Products, Inc.	15ac00f8-da51-6cea-e063-6294a90aeb81	2024-04-09	Warnings	Exact identifier application number: M021
HIMALAYA PINK SALT Intensive Whitening Spearmint	SODIUM FLUORIDE	LG H&H Co.,Ltd.	14ea1776-ef7f-27a9-e063-6394a90afd49	2024-03-29	Warnings	Exact identifier application number: M021
HIMALAYA PINK SALT Intensive Whitening Spearmint	SODIUM FLUORIDE	Tai Guk Pharma. Co., Ltd.	14eb9f74-e5f5-e199-e063-6394a90adbf6	2024-03-29	Warnings	Exact identifier application number: M021
Dentalclean Ultra Refreshing Extreme Ice Dental Gel	SODIUM FLUORIDE 0.24%	Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda	1496636d-6563-d474-e063-6394a90ab73d	2024-03-26	Warnings	Exact identifier application number: M021
Scope Stay Strong	SODIUM FLUORIDE	The Procter & Gamble Manufacturing Company	142bffe1-1e8c-8567-e063-6394a90af15a	2024-03-21	Warnings	Exact identifier application number: M021
Made by Dentists Ultra Whitening Fresh Mint	SODIUM FLUORIDE	MADE BY DENTISTS INC	dbce2aba-48db-4e78-bf79-74f34868ee37	2024-03-15	Warnings	Exact identifier application number: M021
EUTHYMOL Extraordinary Pink Whitening	SODIUM FLUORIDE	Tai Guk Pharm. Co., Ltd.	13907bf6-9a95-c0b2-e063-6394a90a4042	2024-03-13	Warnings	Exact identifier application number: M021

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
C810JCZ56Q	SODIUM MONOFLUOROPHOSPHATE	10163-15-2	SODIUM MONOFLUOROPHOSPHATE
8ZYQ1474W7	SODIUM FLUORIDE	7681-49-4	SODIUM FLUORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1046867	sodium monofluorophosphate 0.16 % / sodium fluoride 0.1 % Toothpaste	PSN	98d839e3-a1aa-c83d-e053-2995a90a7e79	5
1046867	sodium fluoride 0.001 MG/MG / sodium monofluorophosphate 0.0016 MG/MG Toothpaste	SCD	98d839e3-a1aa-c83d-e053-2995a90a7e79	5
1046867	sodium fluoride 0.1 % / sodium monofluorophosphate 0.16 % Toothpaste	SY	98d839e3-a1aa-c83d-e053-2995a90a7e79	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52257-1380-1	52257138001	50 g in 1 TUBE	50 g					Historical
52257-1380-2	52257138002	4 TUBE in 1 CARTON (52257-1380-2) / 50 g in 1 TUBE (52257-1380-1)	4 tube	2019-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
FLUORIDE ION - ATOMY CO., LTD. \| Kolmar Korea Co.,LTD. Gwanjeong 2 factory	ATOMY CO., LTD. \| Kolmar Korea Co.,LTD. Gwanjeong 2 factory	2024-01-30	HUMAN OTC DRUG LABEL	5