Home NDC 48878-3315 PerioMed
Product NDC 48878-3315
11-digit product format 488783315
Labeler code 48878
Product ID 48878-3315_928be263-9602-4672-b460-8f840da667b9
Type HUMAN OTC DRUG
Nonproprietary name Stannous Fluoride
Dosage form RINSE
Route ORAL
Labeler Solventum US LLC
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 1967-07-01
Substance STANNOUS FLUORIDE
Active strength 1.53 mg/g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base PerioMed
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength STANNOUS FLUORIDE 1.53 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3FTR44B32Q Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 48878-3315-0 PerioMed 283.5 g in 1 BOTTLE, PLASTIC RINSE 283.5 9 48878-3315-0 PerioMed 1 in 1 BOX RINSE 1 9 48878-3315-2 PerioMed 85 g in 1 BOTTLE, PLASTIC RINSE 85 9 48878-3315-2 PerioMed 1 in 1 BOX RINSE 1 9
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 48878-3315 PERIOMED (STANNOUS FLUORIDE) RINSE [SOLVENTUM US LLC] 9 Current NDC, Legacy NDC, 4 package rows 20240808_7f79eb00-86df-4284-b415-47f45e4849da.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 21 of 49 · 974 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Enamelon STANNOUS FLUORIDE Premier Dental Products Company 1626375a-f78b-4192-b7f3-ca932acab7fb 2026-01-13 Warnings Exact identifier application number: M021 ACT Anticavity Fluoride Cinnamon SODIUM FLUORIDE Chattem, Inc. f2952ca5-c1c3-42fc-82a4-08662286be44 2026-01-12 Warnings Exact identifier application number: M021 ACT Anticavity Fluoride Kids Wild Watermelon SODIUM FLUORIDE 0.24 (0.14 W/V FLUORIDE ION) Chattem, Inc. bc578c6e-0186-4ac7-ad3a-e8d1e0dcb8a8 2026-01-12 Warnings Exact identifier application number: M021 ACT Kids Anticavity Fluoride Pineapple Punch SODIUM FLUORIDE Chattem, Inc. 2bb69826-12e5-4a4e-8d4a-23a9da6b4b9b 2026-01-12 Warnings Exact identifier application number: M021 Botao Kids Strawberry Flavored with Fluoride BOTAO KIDS STRAWBERRY FLAVORED TOOTHPASTE WITH FLUORIDE Peer Pharm Ltd. 48b8d884-5e15-4145-8521-ae9ee482e392 2026-01-12 Warnings Exact identifier application number: M021 ACT Total Care Anticavity Fluoride Fresh Mint SODIUM FLUORIDE Chattem, Inc. 4ee6a478-afcf-4540-b427-ba08c942ccb3 2026-01-12 Warnings Exact identifier application number: M021 ACT Anticavity Fluoride Mint SODIUM FLUORIDE Chattem, Inc. e81c83a2-363a-442f-8731-2598a4f4c21e 2026-01-12 Warnings Exact identifier application number: M021 ACT Total Care Anticavity Fluoride Icy Clean Mint SODIUM FLUORIDE Chattem, Inc. 258b78b4-55e7-410c-90f8-a3e456c02579 2026-01-12 Warnings Exact identifier application number: M021 ACT Total Care Dry Mouth Anticavity Mouth SODIUM FLUORIDE Chattem, Inc. 06684b82-aaa0-4ca6-8d56-4f9866269000 2026-01-12 Warnings Exact identifier application number: M021 ACT Anticavity Fluoride Kids Groovy Grape SODIUM FLUORIDE Chattem, Inc. cd167c0b-2086-4204-b0ac-90df404bd4bb 2026-01-12 Warnings Exact identifier application number: M021 ACT Total Care Anticavity Fluoride Icy Clean Mint SODIUM FLUORIDE Chattem, Inc. beded786-bb55-4ba3-82fe-9e9d1b5e2979 2026-01-12 Warnings Exact identifier application number: M021 ACT Kids Pure Protect Anticavity- Simply Strawberry SODIUM FLUORIDE Chattem, Inc. 2fc80727-57c7-4a33-80e0-ab9f9487390d 2026-01-12 Warnings Exact identifier application number: M021 ACT Kids Anticavity Fluoride Groovy Grape SODIUM FLUORIDE Chattem, Inc. 310a3c11-1c66-4dac-99f4-5fdc15d0f77c 2026-01-12 Warnings Exact identifier application number: M021 ACT Anticavity Fluoride Kids Bubblegum SODIUM FLUORIDE Chattem, Inc. fbbccd58-a816-4a93-a658-f28246c11e80 2026-01-12 Warnings Exact identifier application number: M021 ACT Whitening Anticavity Gentle Mint SODIUM FLUORIDE 0.02 (0.009 W/V FLUORIDE ION) Chattem, Inc. cd45a0b8-9ab3-4aed-8214-a6dcc4cdaf49 2026-01-12 Warnings Exact identifier application number: M021 ACT Restoring Anticavity Fluoride Cool Mint SODIUM FLUORIDE Chattem, Inc. ef63e193-5804-4b35-bae7-cad29cf4e8bc 2026-01-12 Warnings Exact identifier application number: M021 Prime Tooth Care Blueberry SODIUM FLUORIDE Prime Tooth Care LLC 86642110-4572-4b8b-88f1-8d25fe05701e 2026-01-09 Warnings Exact identifier application number: M021 Prime Tooth Care Juicy Peach SODIUM FLUORIDE Prime Tooth Care LLC 142f1610-3494-459f-a956-760e82169b87 2026-01-09 Warnings Exact identifier application number: M021 Prime Tooth Care Coconut Whip SODIUM FLUORIDE Prime Tooth Care LLC 55e95657-9415-4d9c-ac9b-d021aa14e64d 2026-01-09 Warnings Exact identifier application number: M021 Prime Tooth Care Hami Melon SODIUM FLUORIDE Prime Tooth Care LLC 0028f88d-a9fe-4cfa-a6c6-168f9689b5f6 2026-01-09 Warnings Exact identifier application number: M021
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 48878-3315-0 48878331500 1 BOTTLE, PLASTIC in 1 BOX (48878-3315-0) / 283.5 g in 1 BOTTLE, PLASTIC 1967-07-01 0000-00-00 No No Current 48878-3315-2 48878331502 1 BOTTLE, PLASTIC in 1 BOX (48878-3315-2) / 85 g in 1 BOTTLE, PLASTIC 2016-02-01 0000-00-00 No No Current