Home NDC 51206-302 Opalescence Whitening
Product NDC 51206-302
11-digit product format 512060302
Labeler code 51206
Product ID 51206-302_5b14d90f-23ec-372b-e063-6294a90a2066
Type HUMAN OTC DRUG
Nonproprietary name Sodium Fluoride
Dosage form GEL, DENTIFRICE
Route DENTAL
Labeler Ultradent Products, Inc
Application M021
Marketing category OTC MONOGRAPH DRUG
Marketing start 1994-07-01
Marketing end 2030-09-30
Substance SODIUM FLUORIDE
Active strength 1.1 mg/g
NDC exclude flag No
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 Opalescence Whitening Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM FLUORIDE 1.1 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 8ZYQ1474W7 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1044547 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51206-302-06 Opalescence Whitening 133 g in 1 TUBE GEL, DENTIFRICE 133 9 51206-302-06 Opalescence Whitening 1 in 1 BOX GEL, DENTIFRICE 1 9 51206-302-07 Opalescence Whitening 1 in 1 BOX GEL, DENTIFRICE 1 9 51206-302-07 Opalescence Whitening 28.35 g in 1 TUBE GEL, DENTIFRICE 28.35 9 51206-302-08 Opalescence Whitening 1 in 1 BOX GEL, DENTIFRICE 1 9 51206-302-08 Opalescence Whitening 3 in 1 PACKAGE, COMBINATION GEL, DENTIFRICE 3 9 51206-302-09 Opalescence Whitening 1 in 1 BOX GEL, DENTIFRICE 1 9 51206-302-09 Opalescence Whitening 12 in 1 PACKAGE, COMBINATION GEL, DENTIFRICE 12 9 51206-302-10 Opalescence Whitening 24 in 1 PACKAGE, COMBINATION GEL, DENTIFRICE 24 9 51206-302-10 Opalescence Whitening 1 in 1 BOX GEL, DENTIFRICE 1 9 51206-302-11 Opalescence Whitening 1 in 1 BOX GEL, DENTIFRICE 1 9 51206-302-11 Opalescence Whitening 6 in 1 PACKAGE, COMBINATION GEL, DENTIFRICE 6 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Sodium Fluoride ACTIVE INGREDIENT 8ZYQ1474W7 OPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 1 Fluoride Ion ACTIVE MOIETY Q80VPU408O OPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 1 FD&C Blue No. 1 INACTIVE INGREDIENT H3R47K3TBD OPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 1 FD&C Yellow No. 5 INACTIVE INGREDIENT I753WB2F1M OPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 1 Glycerin INACTIVE INGREDIENT PDC6A3C0OX OPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 1 Methyl Salicylate INACTIVE INGREDIENT LAV5U5022Y OPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 1 Saccharin Sodium INACTIVE INGREDIENT SB8ZUX40TY OPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 1 Silicon Dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 OPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 1 Sodium Benzoate INACTIVE INGREDIENT OJ245FE5EU OPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 1 Sodium Lauryl Sulfate INACTIVE INGREDIENT 368GB5141J OPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 1 Sorbitol INACTIVE INGREDIENT 506T60A25R OPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 1 Water INACTIVE INGREDIENT 059QF0KO0R OPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 1 Xanthan Gum INACTIVE INGREDIENT TTV12P4NEE OPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 1 Xylitol INACTIVE INGREDIENT VCQ006KQ1E OPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51206-302 OPALESCENCE WHITENING (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC] 7 Current NDC, Legacy NDC, 12 package rows 20240224_d07f842e-b6f1-4ae1-b576-f542ecd02dd4.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 50 · 995 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join HISMILE SODIUM FLUORIDE HISMILE PTY LTD 1de591d9-9cab-e63d-e063-6394a90ac8eb 2026-01-15 Warnings Exact identifier application number: M021 Ice Pop Flavor Sodium Fluoride Anticavity Toothpast SODIUM FLUORIDE HISMILE PTY LTD 20e1603e-bcd1-6a5e-e063-6294a90ad1db 2026-01-15 Warnings Exact identifier application number: M021 Hismile CANDY CANE FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE HISMILE PTY LTD 1e725b7e-accc-f51c-e063-6394a90a455c 2026-01-15 Warnings Exact identifier application number: M021 Enamelon Preventive Treatment STANNOUS FLUORIDE Premier Dental Products Company 04c3f178-7905-404d-9ac2-67c453287ddf 2026-01-13 Warnings Exact identifier application number: M021 Enamelon STANNOUS FLUORIDE Premier Dental Products Company 1626375a-f78b-4192-b7f3-ca932acab7fb 2026-01-13 Warnings Exact identifier application number: M021 ARU CAVITY PROTECTION SODIUM FLUORIDE Ashtel Studios, Inc. 97bd2934-4bff-4fdb-9199-fcdc0f77fada 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
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51206-302-06 51206030206 1 TUBE in 1 BOX (51206-302-06) / 133 g in 1 TUBE 1 tube 1994-07-01 2030-09-30 No No Current 51206-302-07 51206030207 1 TUBE in 1 BOX (51206-302-07) / 28.35 g in 1 TUBE 1 tube 1994-07-01 2030-09-30 No No Current 51206-302-08 51206030208 3 BOX in 1 PACKAGE, COMBINATION (51206-302-08) / 1 TUBE in 1 BOX / 133 g in 1 TUBE 3 box 2016-06-01 2030-09-30 No No Current 51206-302-09 51206030209 12 BOX in 1 PACKAGE, COMBINATION (51206-302-09) / 1 TUBE in 1 BOX / 133 g in 1 TUBE 12 box 2016-06-01 2030-09-30 No No Current 51206-302-10 51206030210 24 BOX in 1 PACKAGE, COMBINATION (51206-302-10) / 1 TUBE in 1 BOX / 28.35 g in 1 TUBE 24 box 2016-06-01 2030-09-03 No No Current 51206-302-11 51206030211 6 BOX in 1 PACKAGE, COMBINATION (51206-302-11) / 1 TUBE in 1 BOX / 133 g in 1 TUBE 6 box 2020-08-24 2030-09-30 No No Current