NDC 61269-165 - Sodium Fluoride Drops

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
61269-165
Package NDCs from labels
61269-165-50
Manufacturer
H2-Pharma, LLC
Effective date
2025-09-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sodium Fluoride Drops - H2-Pharma, LLCH2-Pharma, LLC2025-09-16DIETARY SUPPLEMENT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61269-165-50Sodium Fluoride Drops50 mL in 1 BOTTLESOLUTION/ DROPS504
61269-165-50Sodium Fluoride Drops1 in 1 CARTONSOLUTION/ DROPS14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61269-165SODIUM FLUORIDE DROPS (SODIUM FLUORIDE) SOLUTION/ DROPS [H2-PHARMA, LLC]32 package rows20220125_25401aaa-287c-4af0-8628-be30434aee40.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61269-165-50ML - Milliliter61269-16515ce4f32-e06d-46b4-aaa2-84f6d85933ad12017-04-05

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 14 of 64 · 1,273 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
Denti-Care Denti-Rinse Neutral Sodium Fluoride Oral RinseSODIUM FLUORIDEAMD Medicom1da64824-9389-4109-bea9-b91600caf0232026-03-05WarningsExact identifier
unii: 8ZYQ1474W7
PCXX VANILLA ORANGE ONE MINUTE FMSODIUM FLUORIDERoss Healthcare Inc.5e816186-519e-606e-e053-2a91aa0a34602026-03-05Exact identifier
unii: 8ZYQ1474W7
PCXX STRAWBERRY APF FSODIUM FLUORIDERoss Healthcare Inc.5e859333-b798-2dd3-e053-2991aa0af2e32026-03-05Exact identifier
unii: 8ZYQ1474W7
Colgate Maximum Cavity Protection Bubble Fruit FlavorSODIUM FLUORIDEColgate-Palmolive Company0a1389f6-cac9-3d58-0744-c488abb0bbcc2026-03-03WarningsExact identifier
unii: 8ZYQ1474W7
Alcohol-Free AnticavitySODIUM FLUORIDEAmazon.com Services LLC349eca80-2e0c-409b-af29-3235fdc0695b2026-03-03Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Oral AntivavitySODIUM FLUORIDEAmazon.com Services LLC03735abc-d1be-4ca0-a497-0a5c5f2894022026-03-03Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
AnticavitySODIUM FLUORIDEOld East Main Co.f8036e2e-7541-4922-92b9-0d8319f7b64c2026-03-02Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
AnticavitySODIUM FLUORIDEOld East Main Co.64f3d92d-f58c-4bc2-8819-f91492221ddb2026-03-02Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
AnticavitySODIUM FLUORIDEOld East Main Co.c7b9e9cd-3cf7-4657-83c9-e221e1c359772026-03-02Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
PCXX PEPPERMINT NEUTRAL GLSODIUM FLUORIDERoss Healthcare Inc.8287b2de-0289-3eaa-e053-2a91aa0a0bd32026-03-02Exact identifier
unii: 8ZYQ1474W7
PCXX WATERMELON APF GSODIUM FLUORIDERoss Healthcare Inc.8287b2de-028a-3eaa-e053-2a91aa0a0bd32026-03-02Exact identifier
unii: 8ZYQ1474W7
PCXX WATERMELON NEUTRAL GLSODIUM FLUORIDERoss Healthcare Inc.829ac847-27d7-6461-e053-2991aa0a5e9a2026-03-02Exact identifier
unii: 8ZYQ1474W7
PCXX BUBBLEGUM APF GSODIUM FLUORIDERoss Healthcare Inc.827459cc-faf7-3e7c-e053-2a91aa0aa4802026-03-02Exact identifier
unii: 8ZYQ1474W7
PCXX MARSHMALLOW APF GSODIUM FLUORIDERoss Healthcare Inc.827459cc-faf2-3e7c-e053-2a91aa0aa4802026-03-02Exact identifier
unii: 8ZYQ1474W7
AnticavitySODIUM FLUORIDEThe Kroger Co.27a98b64-8369-4f3d-b487-d7ce98abc69f2026-02-27Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
AnticavitySODIUM FLUORIDEThe Kroger Co.390dd1b5-2dd1-4b55-b4b3-e441ada612382026-02-27Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Alcohol-Free AnticavitySODIUM FLUORIDEThe Kroger Co.5459eeee-adf0-4afe-b190-62d4fa1138062026-02-27Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
Oral AntivavitySODIUM FLUORIDEThe Kroger Co.932723b8-9875-4f37-8c11-018c94ae0ae12026-02-27Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7
AnticavitySODIUM FLUORIDEThe Kroger Co.d0c552d8-44ad-4d95-b3fb-17015f44b3342026-02-27Warnings, Adverse reactionsExact identifier
unii: 8ZYQ1474W7

Reported adverse events (FAERS/openFDA)#

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