AMHEALER

Manufacturer: HEALINGAM CO., LTD
Effective date: 2015-06-23
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:42:49

Label at a glance#

ProductAMHEALER

Active ingredientSodium Fluoride

Label structure8 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Sodium Fluoride 0.02%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water, Thiobacillus

PURPOSE

OTC - PURPOSE SECTION

Purpose: Bad breath removal

WARNINGS

WARNINGS SECTION

Warnings: 1. Keep out of reach of babies and children 2. Keep away from direct sunlight

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

1. Keep out of reach of babies and children

INDICATIONS & USAGE

INDICATIONS & USAGE SECTION

Indications & Usage: Open the container cap and press the spray button(1~2 times)

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Dosage & Administration: Do not use more than 5㎖ per day (50 times)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69890-010-01	2020-01-31	C162847	48780-1	9d75b9d1-219f-f424-e053-dadaa90a57ce	81817163-a5b5-4eaa-b014-085c6098d022

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69890-010-01	AMHEALER	35 mL in 1 CARTON	SPRAY	35		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69890-010	AMHEALER (SODIUM FLUORIDE) SPRAY [HEALINGAM CO., LTD]	1	Legacy NDC, 1 package rows	20150623_81817163-a5b5-4eaa-b014-085c6098d022.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Sodium Fluoride	ACTIVE INGREDIENT	8ZYQ1474W7	1
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

AMHEALER
Sodium Fluoride
FLUORIDE ION
Water

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69890-010	69890-010-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Sodium Fluoride	8ZYQ1474W7	ACTIM
Water	059QF0KO0R	IACT

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
fdc7b831-f053-41f5-b013-3b5bee4444e6			81817163-a5b5-4eaa-b014-085c6098d022	2015-06-23	Warnings	Exact identifier spl id: fdc7b831-f053-41f5-b013-3b5bee4444e6 spl set id: 81817163-a5b5-4eaa-b014-085c6098d022

Reported adverse events (FAERS/openFDA)#

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