FDA.reportPublic FDA data

NDC 62776-003 - Made by Dentists Enamel Rebuilding Professional

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
62776-003
Package NDCs from labels
62776-003-01
Manufacturer
Fulijaya Manufacturing Sdn. Bhd
Effective date
2025-06-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
POTASSIUM NITRATE, SODIUM FLUORIDE - Fulijaya Manufacturing Sdn. BhdFulijaya Manufacturing Sdn. Bhd2025-06-23HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62776-003-01Made by Dentists Enamel Rebuilding Professional120 g in 1 TUBEPASTE1202
62776-003-01Made by Dentists Enamel Rebuilding Professional1 in 1 CARTONPASTE12

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 94 of 190 · 3,798 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Hawaiian Tropic Mineral Face Skin Nourishing Tinted Milk Coconut Oil SPF30TITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands LLCeeb3c173-b280-76e4-e053-2995a90a0e792025-11-06WarningsExact identifier
unii: 15FIX9V2JP
Hawaiian Tropic Mineral Skin Nourishing Milk Coconut Oil SPF 50TITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands LLCefcd52c2-4208-46a1-e053-2a95a90a857d2025-11-06WarningsExact identifier
unii: 15FIX9V2JP
PCXX CREME DE MENTHE APF GSODIUM FLUORIDERoss Healthcare Inc.8281bc97-3816-8653-e053-2991aa0a0f502025-11-06Exact identifier
unii: 8ZYQ1474W7
Teething-ColicCHAMOMILLA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, APIS MELLIFICA, BAPTISIA TINCTORIA, BELLADONNA, BORAX, BRYONIA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, CHELIDONIUM MAJUS, COFFEA CRUDA, COLLINSONIA CANADENSIS, COLOCYNTHIS, KREOSOTUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PODOPHYLLUM PELTATUM, RHEUM, SCUTELLARIA LATERIFLORA, SILICEA, TEREBINTHINA, ZINGIBER OFFICINALENewton Laboratories, Inc.9db30229-3031-ff10-e053-2995a90aff752025-11-06WarningsExact identifier
unii: 91D9GV0Z28
Teething-ColicCHAMOMILLA, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, APIS MELLIFICA, BAPTISIA TINCTORIA, BELLADONNA, BORAX, BRYONIA, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, CHELIDONIUM MAJUS, COFFEA CRUDA, COLLINSONIA CANADENSIS, COLOCYNTHIS, KREOSOTUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PODOPHYLLUM PELTATUM, RHEUM, SCUTELLARIA LATERIFLORA, SILICEA, TEREBINTHINA, ZINGIBER OFFICINALENewton Laboratories, Inc.9db4790e-28c2-2dce-e053-2a95a90ae7922025-11-06WarningsExact identifier
unii: 91D9GV0Z28
PCXX GRAPE APF GSODIUM FLUORIDERoss Healthcare Inc.82872a07-04b7-5263-e053-2a91aa0aa2c22025-11-06Exact identifier
unii: 8ZYQ1474W7
PCXX VANILLA ORANGE NEUTRAL GLSODIUM FLUORIDERoss Healthcare Inc.82978289-4943-83b1-e053-2991aa0a63652025-11-06Exact identifier
unii: 8ZYQ1474W7
Stream2Sea Broad Spectrum 20TITANIUM DIOXIDEStream2Sea, LLC1775d07d-6914-6928-e054-00144ff88e882025-11-06WarningsExact identifier
unii: 15FIX9V2JP
PCXX NEUTRAL RNS GRAPEFLUORIDE TREATMENTRoss Healthcare Inc.9c40dff1-ff82-44b3-98e5-7f9cbfd1dad62025-11-06WarningsExact identifier
unii: 8ZYQ1474W7
PCXX NEUTRAL RMS BUBBLEGUMFLUORIDE TREATMENTRoss Healthcare Inc.37f90a0f-2c67-456b-997e-8a8a4f5f09d32025-11-06WarningsExact identifier
unii: 8ZYQ1474W7
PCXX NEUTRAL RNS PEPPERMINTFLUORIDE TREATMENTRoss Healthcare Inc.8532d4d9-c960-0051-e053-2a91aa0ad1a62025-11-06WarningsExact identifier
unii: 8ZYQ1474W7
PHYSICAL TINTED MOISTURIZER SPF44ZINC OXIDE, TITANIUM DIOXIDEDrmtlgy, LLC483d0d28-56f3-4b37-af03-0331e1653d732025-11-06WarningsExact identifier
unii: 15FIX9V2JP
Sodium BicarbonateSODIUM BICARBONATEHospira, Inc.ea20a5eb-641e-48cd-bcfa-74c04c45dfda2025-11-06Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Perricone MD Cold Plasma Plus Neck and Chest Broad Spectrum SPF 25TITANIUM DIOXIDETHG Beauty USA LLC23a55301-2277-6e4f-e063-6394a90af1712025-11-05WarningsExact identifier
unii: 15FIX9V2JP
CEO-TWOLAXATIVEBeutlich Pharmaceuticals, LLC08670636-5795-4db0-e063-6294a90afa4b2025-11-05WarningsExact identifier
unii: 8MDF5V39QO
Omeprazole and sodium bicarbonateOMEPRAZOLE, SODIUM BICARBONATEWalgreen Company8753a131-f8b1-48e1-993b-73c1ee635fef2025-11-04WarningsExact identifier
unii: 8MDF5V39QO
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DentisseSODIUM FLUORIDEDentisse, Inc.326b290a-9bd2-468e-e054-00144ff8d46c2025-11-04WarningsExact identifier
unii: 8ZYQ1474W7
Alpha-ProSODIUM FLUORIDE AND HYDROFLUORIC ACIDDental Technologies, Inc.a86ec65f-f6e1-474d-aeff-412a4716a92c2025-11-04Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7

Reported adverse events (FAERS/openFDA)#

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