INDICATIONS
For topical application to aid in the protection against dental caries.
60-Second Fluoride Gel
- Manufacturer
- Patterson Dental Supply Inc
- Effective date
- 2012-10-09
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-05-31 20:16:08
Label at a glance#
Product60-Second Fluoride Mint
Active ingredientSodium Fluoride
Label structure15 sections
Label contents#
Full prescribing information#
CONTAINS
Fluoride (Sodium Fluoride) – 1.23% w/w.
DOSAGE & ADMINISTRATION
Fill fluoride tray with 2-3ml of fluoride gel per arch. Dry tooth surface and insert tray(s) in mouth. Have patient bite down for 60 seconds (or up to 4 minutes). Slight chewing motion provides interproximal coverage. Remove tray(s) and have patient expectorate excess gel. Inform patient not to eat, drink or rinse for 30 minutes.
CAUTION
For Professional Office use only. This product is not intended for home or unsupervised consumer use.
WARNING
Keep out of reach of children. If more than is used for a fluoride application is swallowed, get medical help or contact a Poison Control Center right away.
HOW SUPPLIED SECTION
STORAGE AND HANDLING SECTION
Store at controlled room temperature:
68-77°F (20-25°C). Prevent from freezing.
Shake well before each use.
SPL UNCLASSIFIED SECTION
Made in U.S.A.
PRINCIPAL DISPLAY PANEL - 454 g Mint Bottle Label
PATTERSON
DENTAL
NDC# 50227-3221-6
60-Second
Fluoride Gel
(APF*)
*Acidulated Phosphate Fluoride
1.23% F Ion
MINT
NET WT. 16 OZ
Reorder Number
088-4288
Manufactured for:
PATTERSON
DENTAL
Patterson Dental Supply, Inc.
1031 Mendota Heights Road
Saint Paul, MN 55120
PRINCIPAL DISPLAY PANEL - 454 g Grape Bottle Label
PATTERSON
DENTAL
NDC# 50227-3231-6
60-Second
Fluoride Gel
(APF*)
*Acidulated Phosphate Fluoride
1.23% F Ion
GRAPE
NET WT. 16 OZ
Reorder Number
088-4296
Manufactured for:
PATTERSON
DENTAL
Patterson Dental Supply, Inc.
1031 Mendota Heights Road
Saint Paul, MN 55120
PRINCIPAL DISPLAY PANEL - 454 g Bubble Gum Bottle Label
PATTERSON
DENTAL
NDC# 50227-3251-6
60-Second
Fluoride Gel
(APF*)
*Acidulated Phosphate Fluoride
1.23% F Ion
BUBBLE GUM
NET WT. 16 OZ
Reorder Number
088-4247
Manufactured for:
PATTERSON
DENTAL
Patterson Dental Supply, Inc.
1031 Mendota Heights Road
Saint Paul, MN 55120
PRINCIPAL DISPLAY PANEL - 454 g Strawberry Bottle Label
PATTERSON
DENTAL
NDC# 50227-3281-6
60-Second
Fluoride Gel
(APF*)
*Acidulated Phosphate Fluoride
1.23% F Ion
STRAWBERRY
NET WT. 16 OZ
Reorder Number
088-4270
Manufactured for:
PATTERSON
DENTAL
Patterson Dental Supply, Inc.
1031 Mendota Heights Road
Saint Paul, MN 55120
PRINCIPAL DISPLAY PANEL - 454 g Orange Cream Bottle Label
PATTERSON
DENTAL
NDC# 50227-3271-6
60-Second
Fluoride Gel
(APF*)
*Acidulated Phosphate Fluoride
1.23% F Ion
ORANGE CREAM
NET WT. 16 OZ
Reorder Number
088-4262
Manufactured for:
PATTERSON
DENTAL
Patterson Dental Supply, Inc.
1031 Mendota Heights Road
Saint Paul, MN 55120
PRINCIPAL DISPLAY PANEL - 454 g Marshmallow Bottle Label
PATTERSON
DENTAL
NDC# 50227-3261-6
60-Second
Fluoride Gel
(APF*)
*Acidulated Phosphate Fluoride
1.23% F Ion
MARSHMALLOW
NET WT. 16 OZ
Reorder Number
088-4254
Manufactured for:
PATTERSON
DENTAL
Patterson Dental Supply, Inc.
1031 Mendota Heights Road
Saint Paul, MN 55120
PRINCIPAL DISPLAY PANEL - 454 g Cherry Bottle Label
PATTERSON
DENTAL
NDC# 50227-3211-6
60-Second
Fluoride Gel
(APF*)
*Acidulated Phosphate Fluoride
1.23% F Ion
CHERRY
NET WT. 16 OZ
Reorder Number
088-4353
Manufactured for:
PATTERSON
DENTAL
Patterson Dental Supply, Inc.
1031 Mendota Heights Road
Saint Paul, MN 55120
PRINCIPAL DISPLAY PANEL - 454 g Piña Colada Bottle Label
PATTERSON
DENTAL
NDC# 50227-3241-6
60-Second
Fluoride Gel
(APF*)
*Acidulated Phosphate Fluoride
1.23% F Ion
PIÑA COLADA
NET WT. 16 OZ
Reorder Number
088-4346
Manufactured for:
PATTERSON
DENTAL
Patterson Dental Supply, Inc.
1031 Mendota Heights Road
Saint Paul, MN 55120
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50227-3211-6 | 2019-11-27 | C162847 | 48780-1 | 9855d018-ecd5-cd31-e053-dbdaa90ab51a | 60-Second Fluoride Gel |
| 50227-3221-6 | 2019-11-27 | C162847 | 48780-1 | 9855d018-ecd5-cd31-e053-dbdaa90ab51a | 60-Second Fluoride Gel |
| 50227-3241-6 | 2019-11-27 | C162847 | 48780-1 | 9855d018-ecd5-cd31-e053-dbdaa90ab51a | 60-Second Fluoride Gel |
| 50227-3251-6 | 2019-11-27 | C162847 | 48780-1 | 9855d018-ecd5-cd31-e053-dbdaa90ab51a | 60-Second Fluoride Gel |
| 50227-3271-6 | 2019-11-27 | C162847 | 48780-1 | 9855d018-ecd5-cd31-e053-dbdaa90ab51a | 60-Second Fluoride Gel |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50227-3211-6 | 60-Second Fluoride Cherry | 454 g in 1 BOTTLE, PLASTIC | GEL | 454 | 3 | |
| 50227-3221-6 | 60-Second Fluoride Mint | 454 g in 1 BOTTLE, PLASTIC | GEL | 454 | 3 | |
| 50227-3231-6 | 60-Second Fluoride Grape | 454 g in 1 BOTTLE, PLASTIC | GEL | 454 | 3 | |
| 50227-3241-6 | 60-Second Fluoride Pina Colada | 454 g in 1 BOTTLE, PLASTIC | GEL | 454 | 3 | |
| 50227-3251-6 | 60-Second Fluoride Bubble Gum | 454 g in 1 BOTTLE, PLASTIC | GEL | 454 | 3 | |
| 50227-3261-6 | 60-Second Fluoride Marshmallow | 454 g in 1 BOTTLE, PLASTIC | GEL | 454 | 3 | |
| 50227-3271-6 | 60-Second Fluoride Orange Cream | 454 g in 1 BOTTLE, PLASTIC | GEL | 454 | 3 | |
| 50227-3281-6 | 60-Second Fluoride Strawberry | 454 g in 1 BOTTLE, PLASTIC | GEL | 454 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50227-3211 | 60-SECOND FLUORIDE MINT (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE GRAPE (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE BUBBLE GUM (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE STRAWBERRY (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE ORANGE CREAM (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE MARSHMALLOW (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE CHERRY (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE PINA COLADA (SODIUM FLUORIDE) GEL [PATTERSON DENTAL SUPPLY INC] | 3 | Legacy NDC, 1 package rows | 20121017_ad3685e0-c6f0-49dd-b638-eec7ec7be795.zip |
| 50227-3221 | 60-SECOND FLUORIDE MINT (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE GRAPE (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE BUBBLE GUM (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE STRAWBERRY (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE ORANGE CREAM (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE MARSHMALLOW (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE CHERRY (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE PINA COLADA (SODIUM FLUORIDE) GEL [PATTERSON DENTAL SUPPLY INC] | 3 | Legacy NDC, 1 package rows | 20121017_ad3685e0-c6f0-49dd-b638-eec7ec7be795.zip |
| 50227-3231 | 60-SECOND FLUORIDE MINT (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE GRAPE (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE BUBBLE GUM (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE STRAWBERRY (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE ORANGE CREAM (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE MARSHMALLOW (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE CHERRY (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE PINA COLADA (SODIUM FLUORIDE) GEL [PATTERSON DENTAL SUPPLY INC] | 3 | 1 package rows | 20121017_ad3685e0-c6f0-49dd-b638-eec7ec7be795.zip |
| 50227-3241 | 60-SECOND FLUORIDE MINT (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE GRAPE (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE BUBBLE GUM (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE STRAWBERRY (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE ORANGE CREAM (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE MARSHMALLOW (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE CHERRY (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE PINA COLADA (SODIUM FLUORIDE) GEL [PATTERSON DENTAL SUPPLY INC] | 3 | Legacy NDC, 1 package rows | 20121017_ad3685e0-c6f0-49dd-b638-eec7ec7be795.zip |
| 50227-3251 | 60-SECOND FLUORIDE MINT (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE GRAPE (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE BUBBLE GUM (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE STRAWBERRY (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE ORANGE CREAM (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE MARSHMALLOW (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE CHERRY (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE PINA COLADA (SODIUM FLUORIDE) GEL [PATTERSON DENTAL SUPPLY INC] | 3 | Legacy NDC, 1 package rows | 20121017_ad3685e0-c6f0-49dd-b638-eec7ec7be795.zip |
| 50227-3261 | 60-SECOND FLUORIDE MINT (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE GRAPE (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE BUBBLE GUM (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE STRAWBERRY (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE ORANGE CREAM (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE MARSHMALLOW (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE CHERRY (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE PINA COLADA (SODIUM FLUORIDE) GEL [PATTERSON DENTAL SUPPLY INC] | 3 | 1 package rows | 20121017_ad3685e0-c6f0-49dd-b638-eec7ec7be795.zip |
| 50227-3271 | 60-SECOND FLUORIDE MINT (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE GRAPE (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE BUBBLE GUM (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE STRAWBERRY (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE ORANGE CREAM (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE MARSHMALLOW (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE CHERRY (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE PINA COLADA (SODIUM FLUORIDE) GEL [PATTERSON DENTAL SUPPLY INC] | 3 | Legacy NDC, 1 package rows | 20121017_ad3685e0-c6f0-49dd-b638-eec7ec7be795.zip |
| 50227-3281 | 60-SECOND FLUORIDE MINT (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE GRAPE (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE BUBBLE GUM (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE STRAWBERRY (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE ORANGE CREAM (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE MARSHMALLOW (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE CHERRY (SODIUM FLUORIDE) GEL 60-SECOND FLUORIDE PINA COLADA (SODIUM FLUORIDE) GEL [PATTERSON DENTAL SUPPLY INC] | 3 | 1 package rows | 20121017_ad3685e0-c6f0-49dd-b638-eec7ec7be795.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Sodium Fluoride | ACTIVE INGREDIENT | 8ZYQ1474W7 | 3 | |
| Fluoride Ion | ACTIVE MOIETY | Q80VPU408O | 3 | |
| Anhydrous Citric Acid | INACTIVE INGREDIENT | XF417D3PSL | 3 | |
| Hydrofluoric Acid | INACTIVE INGREDIENT | RGL5YE86CZ | 3 | |
| MAGNESIUM ALUMINUM SILICATE | INACTIVE INGREDIENT | 6M3P64V0NC | 3 | |
| Phosphoric Acid | INACTIVE INGREDIENT | E4GA8884NN | 3 | |
| Polysorbate 20 | INACTIVE INGREDIENT | 7T1F30V5YH | 3 | |
| SACCHARIN SODIUM DIHYDRATE | INACTIVE INGREDIENT | SB8ZUX40TY | 3 | |
| Sodium Benzoate | INACTIVE INGREDIENT | OJ245FE5EU | 3 | |
| Titanium Dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | 3 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 3 | |
| Xanthan Gum | INACTIVE INGREDIENT | TTV12P4NEE | 3 | |
| Xylitol | INACTIVE INGREDIENT | VCQ006KQ1E | 3 |
Products#
Every source-derived product name is available through these pages.
- 60-Second Fluoride Mint
- Sodium Fluoride
- Fluoride Ion
- Water
- MAGNESIUM ALUMINUM SILICATE
- Phosphoric Acid
- Hydrofluoric Acid
- Anhydrous Citric Acid
- Xanthan Gum
- Xylitol
- Polysorbate 20
- SACCHARIN SODIUM DIHYDRATE
- Sodium Benzoate
- Titanium Dioxide
- 60-Second Fluoride Grape
- 60-Second Fluoride Bubble Gum
- 60-Second Fluoride Strawberry
- 60-Second Fluoride Orange Cream
- 60-Second Fluoride Marshmallow
- 60-Second Fluoride Cherry
- 60-Second Fluoride Pina Colada
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50227-3221 | 50227-3221-6 |
| 50227-3231 | 50227-3231-6 |
| 50227-3251 | 50227-3251-6 |
| 50227-3281 | 50227-3281-6 |
| 50227-3271 | 50227-3271-6 |
| 50227-3261 | 50227-3261-6 |
| 50227-3211 | 50227-3211-6 |
| 50227-3241 | 50227-3241-6 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Phosphoric Acid | PHOSPHORIC ACID | E4GA8884NN | TABLET, ORALLY DISINTEGRATING / ORAL | 4 mg | ||
| Phosphoric Acid | PHOSPHORIC ACID | E4GA8884NN | GEL / TOPICAL | ADJ PH | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | GEL / TOPICAL | 0.06 %w/w | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | GEL / RECTAL | 406 mg | ||
| Xylitol | XYLITOL | VCQ006KQ1E | SUSPENSION / ORAL | 1500 mg | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | SUSPENSION / RECTAL | 14480 mg | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | SYRUP / ORAL | 80 mg | ||
| Phosphoric Acid | PHOSPHORIC ACID | E4GA8884NN | INJECTION / INTRA-ARTICULAR | ADJ PH | ||
| Anhydrous Citric Acid | ANHYDROUS CITRIC ACID | XF417D3PSL | AEROSOL, FOAM / TOPICAL | 6 mg | ||
| Xylitol | XYLITOL | VCQ006KQ1E | TABLET, EXTENDED RELEASE / ORAL | 2752 mg | ||
| Polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | TABLET / ORAL | 17 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | POWDER, FOR SUSPENSION / ORAL | 600 mg | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | INJECTION, SOLUTION / INTRAMUSCULAR | 4.8 %w/v | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | TROCHE / ORAL | 948 mg | ||
| Polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | SUPPOSITORY / VAGINAL | NA | ||
| Polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | CLOTH / TOPICAL | NA | ||
| SACCHARIN SODIUM DIHYDRATE | SACCHARIN SODIUM | SB8ZUX40TY | AEROSOL, METERED / RESPIRATORY (INHALATION) | 0.05 %w/w | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | SUSPENSION / ORAL | 320 mg | ||
| SACCHARIN SODIUM DIHYDRATE | SACCHARIN SODIUM | SB8ZUX40TY | SUSPENSION / ORAL | 5000 mg/5ml | ||
| Polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | AEROSOL, FOAM / VAGINAL | 3 %w/w | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | SYRUP / ORAL | 100 mg/1ml | ||
| Anhydrous Citric Acid | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET, EXTENDED RELEASE / ORAL | 312 mg | ||
| Xylitol | XYLITOL | VCQ006KQ1E | SPRAY / SUBLINGUAL | 22 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | SOAP / TOPICAL | 1 %w/w | ||
| Phosphoric Acid | PHOSPHORIC ACID | E4GA8884NN | PASTE, DENTIFRICE / DENTAL | ADJ PH | ||
| Anhydrous Citric Acid | ANHYDROUS CITRIC ACID | XF417D3PSL | SPRAY / TOPICAL | 0.01 %w/w | ||
| Anhydrous Citric Acid | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION, SOLUTION / INTRAMUSCULAR | 25 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | TABLET, CHEWABLE, EXTENDED RELEASE / ORAL | 6 mg | ||
| Anhydrous Citric Acid | ANHYDROUS CITRIC ACID | XF417D3PSL | SUSPENSION / RESPIRATORY (INHALATION) | 1 mg | ||
| Phosphoric Acid | PHOSPHORIC ACID | E4GA8884NN | SPONGE / TOPICAL | ADJ PH | ||
| Anhydrous Citric Acid | ANHYDROUS CITRIC ACID | XF417D3PSL | ELIXIR / ORAL | 90 mg | ||
| Polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 60 mg | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | SOLUTION / ORAL | 660 mg | ||
| Anhydrous Citric Acid | ANHYDROUS CITRIC ACID | XF417D3PSL | LIQUID / INTRAVENOUS | 18 mg | ||
| Anhydrous Citric Acid | ANHYDROUS CITRIC ACID | XF417D3PSL | SPRAY, METERED / NASAL | 1.2 mg/1ml | ||
| SACCHARIN SODIUM DIHYDRATE | SACCHARIN SODIUM | SB8ZUX40TY | PASTE, DENTIFRICE / DENTAL | 0.2 %w/w | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | SOLUTION / TOPICAL | 0.1 %w/v | ||
| Anhydrous Citric Acid | ANHYDROUS CITRIC ACID | XF417D3PSL | GRANULE, FOR SUSPENSION / ORAL | 30 mg | ||
| Sodium Benzoate | SODIUM BENZOATE | OJ245FE5EU | TABLET, FILM COATED / ORAL | 1 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | POWDER, FOR SUSPENSION / ORAL | 297 mg | ||
| SACCHARIN SODIUM DIHYDRATE | SACCHARIN SODIUM | SB8ZUX40TY | POWDER, FOR SUSPENSION / ORAL | 85 mg | ||
| Phosphoric Acid | PHOSPHORIC ACID | E4GA8884NN | LOTION, AUGMENTED / TOPICAL | 1 mg | ||
| SACCHARIN SODIUM DIHYDRATE | SACCHARIN SODIUM | SB8ZUX40TY | SYRUP / ORAL | 24 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING / ORAL | 6 mg | ||
| Anhydrous Citric Acid | ANHYDROUS CITRIC ACID | XF417D3PSL | CONCENTRATE / ORAL | 84 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | GRANULE, FOR SUSPENSION / ORAL | 143 mg | ||
| Polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | SOAP / TOPICAL | 0.02 %w/w | ||
| Polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | INJECTION / SUBCUTANEOUS | NA | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | SUSPENSION / ORAL | 5000 mg/5ml | ||
| Anhydrous Citric Acid | ANHYDROUS CITRIC ACID | XF417D3PSL | INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS | 81 mg | ||
| Anhydrous Citric Acid | ANHYDROUS CITRIC ACID | XF417D3PSL | CREAM / TOPICAL | 1 mg | ||
| MAGNESIUM ALUMINUM SILICATE | MAGNESIUM ALUMINUM SILICATE | 6M3P64V0NC | SHAMPOO / TOPICAL | 1.25 %w/w | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | LOZENGE / ORAL | 1264 mg | ||
| Xanthan Gum | XANTHAN GUM | TTV12P4NEE | LOTION / TOPICAL | 0.3 %w/v | ||
| Anhydrous Citric Acid | ANHYDROUS CITRIC ACID | XF417D3PSL | CONCENTRATE / INTRAVENOUS | ADJ PH | ||
| Anhydrous Citric Acid | ANHYDROUS CITRIC ACID | XF417D3PSL | TABLET, ORALLY DISINTEGRATING / ORAL | 46 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| Anhydrous Citric Acid | ANHYDROUS CITRIC ACID | XF417D3PSL | SYRUP / ORAL | 268 mg | ||
| SACCHARIN SODIUM DIHYDRATE | SACCHARIN SODIUM | SB8ZUX40TY | TABLET, ORALLY DISINTEGRATING / ORAL | 10 mg | ||
| Titanium Dioxide | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / RESPIRATORY (INHALATION) | NA |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| ea05caa6-a1b7-41f7-8c4a-8b0458dfbfc3 | ad3685e0-c6f0-49dd-b638-eec7ec7be795 | 2012-10-09 | Warnings | ea05caa6-a1b7-41f7-8c4a-8b0458dfbfc3 ad3685e0-c6f0-49dd-b638-eec7ec7be795 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.