NDC 76357-489-02 - 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
Requested NDC: 76357-489-02
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 161 of 189 · 3,765 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Meijer Redness Relief	GLYCERIN, NAPHAZOLINE HCI	Meijer Distribution, Inc.	9fea4e43-7525-bb66-e053-2a95a90acee9	2023-12-22	Warnings	Exact identifier unii: PDC6A3C0OX
Meijer Ultra Lubricant Eye Drops High Performance	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Meijer Distribution, Inc.	a0846e3e-687c-fd55-e053-2995a90a673e	2023-12-22	Warnings	Exact identifier unii: 6DC9Q167V3
Meijer Dry Eye Relief	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Meijer Distribution, Inc.	9feaa5e2-6aca-96e8-e053-2a95a90a54bd	2023-12-22	Warnings	Exact identifier unii: PDC6A3C0OX
Dermoplast Pain relieving	BENZOCAINE, MENTHOL	Advantice Health	dad00c95-4e11-3eec-e053-2a95a90a7a18	2023-12-21	Warnings	Exact identifier unii: L7T10EIP3A
HempNesic	MENTHOL, CAMPHOR	Blaine Labs Inc.	0239ada0-644d-4ef4-a3b8-df70246a3bc2	2023-12-21	Warnings	Exact identifier unii: L7T10EIP3A
HempNesic	MENTHOL, CAMPHOR	Blaine Labs Inc.	a698502d-c1c5-41ca-8142-74338b834c8b	2023-12-21	Warnings	Exact identifier unii: L7T10EIP3A
Valtrum IMMEDIATE ACTION TOPICAL ANALGESIC	CAMPHOR, MENTHOL, METHYL SALICYLATE	LABORATORIOS QUANTIUM LLC	c4efa317-8dd1-49e1-b7ca-9df2147edd3e	2023-12-21	Warnings	Exact identifier unii: L7T10EIP3A
NUMSTAT Antiseptic and Pain Relieving Prep Pad	ALCOHOL, MENTHOL, AND BENZOCAINE PREP PAD	Spectra Medical Devices, LLC	07d20040-9dd9-0aba-e063-6294a90ab7cf	2023-12-20	Warnings	Exact identifier unii: L7T10EIP3A
CVS Cold and Hot Roll-On	COOL AND HEAT PAIN RELIEF	CVS Pharmacy	b8cc578a-be6d-90c0-e053-2995a90a7742	2023-12-20	Warnings	Exact identifier unii: L7T10EIP3A
Walgreens Multi-Symptom Relief Eye Drops	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATE	Walgreen Co.	a03789ce-66bd-7b12-e053-2995a90af85a	2023-12-20	Warnings	Exact identifier unii: PDC6A3C0OX
Walgreens Eye Drops Maximum Redness Relief 15mL	GLYCERIN, NAPHAZOLINE HCI	Walgreen Company	949d4a4d-b0f8-81f8-e053-2995a90a818d	2023-12-20	Warnings	Exact identifier unii: PDC6A3C0OX
Walgreens Lubricant Eye Drops High Performance 15mL and twin pack	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Walgreen Company	94ee8310-1c19-dfd4-e053-2a95a90a8356	2023-12-20	Warnings	Exact identifier unii: 6DC9Q167V3
Walgreens Redness Relief Eye Drops 15mL	GLYCERIN, NAPHAZOLINE HCI	Walgreen Company	94a0d08a-a6db-1088-e053-2995a90ab4fd	2023-12-20	Warnings	Exact identifier unii: PDC6A3C0OX
Walgreens Lubricant Eye Drops Dry Eye 15mL and twin pack	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Walgreen Company	94f6e1cd-073c-61ca-e053-2a95a90ae725	2023-12-20	Warnings	Exact identifier unii: 6DC9Q167V3
Target Eye Drops Maximum Redness Relief Eye	GLYCERIN, NAPHAZOLINE HYDROCHLORIDE	Target Corporation	1b26cd3b-4a05-4623-b320-01f22b3106ff	2023-12-20	Warnings	Exact identifier unii: PDC6A3C0OX
Kroger High Performance Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Kroger	d2aa8963-1922-02f3-e053-2a95a90a7d93	2023-12-20	Warnings	Exact identifier unii: 6DC9Q167V3
TopCare Health Dry Eye Relief Eye Drops	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	Topco Associates LLC	9c617e34-fc66-1a5b-e053-2995a90ace2c	2023-12-20	Warnings	Exact identifier unii: PDC6A3C0OX
Topcare Health Lubricant Eye Drops	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Topco Assoc LLC	9c6284f9-00bb-37b5-e053-2a95a90ae2ee	2023-12-20	Warnings	Exact identifier unii: 6DC9Q167V3
HEB Dry Eye Eye Drops	GLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400	HEB	f80023cf-8e42-780a-e053-6294a90a66cd	2023-12-20	Warnings	Exact identifier unii: PDC6A3C0OX
Topcare Maximum Redness Relief Eye Drops	GLYCERIN, NAPHAZOLINE HYDROCHLORIDE	Topco Assoc LLC	9c6193a6-d824-1b27-e053-2995a90ab3cf	2023-12-20	Warnings	Exact identifier unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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