NDC 76357-489 - SmartMouth Mouthwash SmartMouth Mouth Sore Zinc Activated Formula

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 76357-489
Package NDCs from labels: 76357-489-02
Manufacturer: Triumph Pharmaceuticals, Inc.
Effective date: 2024-12-18
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
SmartMouth™ Mouthwash Mouth Sore Solution 1	Triumph Pharmaceuticals, Inc.	2024-12-18	HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76357-489-02	SmartMouth Mouthwash SmartMouth Mouth Sore Zinc Activated Formula	237 mL in 1 BOTTLE	LIQUID	237 mL	10 mg in 20mL	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76357-489	SMARTMOUTH MOUTHWASH SMARTMOUTH MOUTH SORE ZINC ACTIVATED FORMULA (MENTHOL, UNSPECIFIED FORM) KIT [TRIUMPH PHARMACEUTICALS, INC.]	1	Unmatched	20250101_f1e5f1e0-ad3f-4bc6-a2ca-5ec71f081815.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 125 of 189 · 3,765 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TREE ANTIGEN	POPULUS TRISTIS POLLEN, JUGLANS NIGRA POLLEN, ACER NEGUNDO POLLEN, ALNUS RUBRA POLLEN, JUNIPERUS VIRGINIANA POLLEN, ULMUS RUBRA POLLEN, ACER PSEUDOPLANUS POLLEN, FRAXINUS AMERICANA POLLEN, CARYA TOMENTOSA POLLEN, ONION, ARSENIC TRIOXIDE, ATROPA BELLADONNA, ACTIVATED CHARCOAL, EUPHRASIA OFFICINALIS, LYCOPODIUM CLAVITUM SPORE, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PULSITILLA VULGARIS WHOLE	Natural Creations, Inc	8040ab36-90eb-4076-a478-9b82ccfa4ec9	2024-12-23	Warnings	Exact identifier unii: 451W47IQ8X
Sterile Hypertonic Saline Solution 7 Sodium Chloride	SODIUM CHLORIDE	JOONEM LLC	e7110525-9f9b-5b68-e053-2995a90ac034	2024-12-23	Warnings	Exact identifier unii: 451W47IQ8X
GNP Anti Itch	CAMPHOR, MENTHOL	AMERISOURCEBERGEN DRUG CORPORATION	b4f2d6f7-2287-47d8-e053-2995a90ae335	2024-12-23	Warnings	Exact identifier unii: L7T10EIP3A
Base Laboratories Saline	SODIUM CHLORIDE	Joonem LLC	49309411-9af4-4f19-a3bf-dbeabc106827	2024-12-23	Warnings	Exact identifier unii: 451W47IQ8X
Base Laboratories Saline	SODIUM CHLORIDE	Joonem LLC	ba0868f6-d3de-40e2-bcb3-144fa53062c7	2024-12-23	Warnings	Exact identifier unii: 451W47IQ8X
Base Laboratories Saline	SODIUM CHLORIDE	Joonem LLC	9d83f477-ebbc-4248-8445-769178181d4f	2024-12-23	Warnings	Exact identifier unii: 451W47IQ8X
cool and heat pain relieving liquid	MENTHOL	Bionpharma Inc.	ec6f59d8-45c5-46a0-e053-2995a90a239f	2024-12-23	Warnings	Exact identifier unii: L7T10EIP3A
Pedia-Lax	GLYCERIN	C.B. Fleet Company, Inc.	4e15f6ca-a40c-485f-be3f-07c2ed7cb498	2024-12-23	Warnings	Exact identifier unii: PDC6A3C0OX
OASIS Tears Preservative-Free Lubricant Eye	GLYCERIN	OASIS Medical, Inc.	d9d71b1d-82a6-42e7-9ef2-2d041daef936	2024-12-23	Warnings	Exact identifier unii: PDC6A3C0OX
Household Antigens	ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PROPYLPARABEN, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUR, PARAFFINUM	Energique, Inc.	f3db63df-62a4-48d6-92e7-94e4a5701552	2024-12-20	Warnings	Exact identifier unii: 6DC9Q167V3
Muscle Rub Cream	MENTHOL 10%, METHYL SALICYLATE 15%	Trifecta Pharmaceuticals USA, LLC.	44d3638d-f29b-0e01-e054-00144ff88e88	2024-12-20	Warnings	Exact identifier unii: L7T10EIP3A
Rhuli Gel	CAMPHOR, MENTHOL	Trifecta Pharmaceuticals USA, LLC.	4fbb3c23-ed47-336e-e054-00144ff8d46c	2024-12-20	Warnings	Exact identifier unii: L7T10EIP3A
Halls Honey Vanilla	MENTHOL	Mondelez Global LLC	8e94a1b8-8915-4595-b097-8a0a319d54aa	2024-12-20	Warnings	Exact identifier unii: L7T10EIP3A
Halls Sugar Free Mentho-Lyptus	MENTHOL	Mondelez Global LLC	96046858-c57b-426e-8279-91b35e05bcdb	2024-12-20	Warnings	Exact identifier unii: L7T10EIP3A
DCH Cooling Pain Relief	MENTHOL 10.5%	Derma Care Research Labs, LLC	00dcdae0-c744-8402-e063-6294a90a12f8	2024-12-20	Warnings	Exact identifier unii: L7T10EIP3A
Outback Pain Relief	CAMPHOR 6%, MENTHOL 16%	Derma Care Research Labs, LLC	c238c930-2012-2d48-e053-2a95a90a8a4a	2024-12-20	Warnings	Exact identifier unii: L7T10EIP3A
Meijer Pain Relief	MENTHOL 10.5%	Meijer	bed81975-bd63-cf5b-e053-2995a90ac5fa	2024-12-20	Warnings	Exact identifier unii: L7T10EIP3A
Vaporising Chest Rub	CAMPHOR, MENTHOL, EUCALYPTUS OIL	New Pride Corp	f66476d5-036b-0b1c-e053-2a95a90a0a07	2024-12-19	Warnings	Exact identifier unii: L7T10EIP3A
Medicated Body Powder	MENTHOL	New Pride Corp	f0f0e332-cb93-42a7-e053-2995a90ac4ae	2024-12-19	Warnings	Exact identifier unii: L7T10EIP3A
Health Smart Medicated Body	MENTHOL AND ZINC OXIDE	International Wholesale Inc dba Home Smart Products	044870e2-ebac-a095-e063-6294a90a2751	2024-12-19	Warnings	Exact identifier unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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