Indications and uses
builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact. aids in the prevention of dental cavities.
SENSODYNE PRONAMEL
- Manufacturer
- Haleon US Holdings LLC
- Effective date
- 2024-01-24
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 21
- Source
- full-release
- Hydrated at
- 2026-06-01 00:07:52
Label at a glance#
ProductSENSODYNE PRONAMEL Gentle Whitening
Active ingredientPOTASSIUM NITRATE, SODIUM FLUORIDE
Label structure15 sections
Dosage and administration
adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristle toothbrush. brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing. children under 12 years of age: Consult...
Storage and handling
do not store above 30°C (86°F)
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients
Potassium nitrate 5%
Sodium fluoride 0.25% (0.15% w/v fluoride ion)
Purpose
Antihypersensitivity
Anticavity
Uses
- builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
- aids in the prevention of dental cavities.
Warnings
Stop use and ask a dentist if
- the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
- pain/sensitivity still persists after 4 weeks of use.
Keep out of reach of children.
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Directions
- adults and children 12 years of age and older:
- apply at least a 1-inch strip of the product onto a soft bristle toothbrush.
- brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.
- children under 12 years of age:Consult a dentist or doctor.
Other information (Gentle Whitening, Daily Protection, Fresh Breath, Multi-Action)
- do not store above 30°C (86°F)
Inactive ingredients (Gentle Whitening)
water, sorbitol, hydrated silica, glycerin, PEG-8, cocamidopropyl betaine, flavor, titanium dioxide, xanthan gum, sodium saccharin, sodium hydroxide
Inactive ingredients (Daily Protection)
water, sorbitol, hydrated silica, glycerin, PEG-8, cocamidopropyl betaine, flavor, xanthan gum, sodium saccharin, titanium dioxide, sodium hydroxide
Inactive ingredients (Fresh Breath)
water, sorbitol, hydrated silica, glycerin, PEG-8, cocamidopropyl betaine, flavor, xanthan gum, sodium saccharin, titanium dioxide, sodium hydroxide
Inactive ingredients (Multi-Action)
water, sorbitol, hydrated silica, glycerin, flavor, cocamidopropyl betaine, xanthan gum, sodium saccharin, mica, titanium dioxide, sodium hydroxide
Questions or comments?
1-866-844-2797
Principal Display Panel
NDC 0135-0484-01
SENSODYNE
PRONAMEL
TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION
Alpine Breeze
GENTLE WHITENING
Specialist Enamel Protection
Rebuilds, Restores, Refreshes
NET WT 4.0 OZ (113g)
ALWAYS FOLLOW THE LABEL
SENSODYNE PRONAMEL
Does not contain: SLS/sulfates • artificial dyes • parabens • triclosan • peroxide
Acidic foods and drinks can cause enamel loss that can lead to yellowing, dullness and sensitivity. Pronamel has a specialty formulation to help rebuild and restore acid weakened enamel, helping prevent enamel loss for strong, healthy teeth.
ACID ATTACKS ENAMEL
WEAKENING THE ENAMEL STRUCTURE
PRONAMEL REBUILDS & RESTORES ENAMEL
FOR STRONG HEALTHY TEETH
Healthy white teeth start with strong enamel.
Pronamel has a proven specialist technology that has been developed to maximize the effect of fluoride on enamel.
With twice-daily brushing,
Pronamel helps to:
- Rebuild enamel strength for strong, healthy teeth
- Protect against the effects of dietary acids
- Relieve sensitive teeth
- Freshen breath
- Protect against cavities
Recycle Carton, Tube and Cap†
Save Water Turn off tap while brushing
†Recycling facilities for this product may not exist in your area
Distributed by:
GSKConsumer Healthcare
Warren, NJ 07059
Trademarks are owned by or licensed to the GSK group of companies.
©2021 GSK group of companies or its licensor.
62000000068970 Front Carton
Principal Display Panel
NDC 0135-0460-01
SENSODYNE
PRONAMEL
TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION
Mint Essence
DAILY PROTECTION
Specialist Enamel Protection
Rebuilds, Restores, Refreshes
NET WT 4.0 OZ (113 g)
ALWAYS FOLLOW THE LABEL
SENSODYNE PRONAMEL
Does not contain: SLS/sulfates • artificial dyes • parabens • triclosan • peroxide
Acidic foods and drinks can cause enamel loss that can lead to yellowing, dullness and sensitivity. Pronamel has a specialty formulation to help rebuild and restore acid weakened enamel, helping prevent enamel loss for strong, healthy teeth.
ACID ATTACKS ENAMEL
WEAKENING THE ENAMEL STRUCTURE
PRONAMEL REBUILDS & RESTORES ENAMEL
FOR STRONG HEALTHY TEETH
Healthy white teeth start with strong enamel.
Pronamel has a proven specialist technology that has been developed to maximize the effect of fluoride on enamel.
With twice-daily brushing,
Pronamel helps to:
- Rebuild enamel strength for strong, healthy teeth
- Protect against the effects of dietary acids
- Relieve sensitive teeth
- Freshen breath
- Protect against cavities
Recycle Carton, Tube and Cap†
Save Water Turn off tap while brushing
†Recycling facilities for this product may not exist in your area
Distributed by:
GSKConsumer Healthcare
Warren, NJ 07059
Trademarks are owned by or licensed to the GSK group of companies.
©2021 GSK group of companies or its licensor.
62000000068992 Front Carton
Principal Display Panel
NDC 0135-0520-01
SENSODYNE
PRONAMEL
TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION
Fresh Wave
FRESH BREATH
Specialist Enamel Protection
Rebuilds, Restores, Refreshes
NET WT 4.0 OZ (113 g)
ALWAYS FOLLOW THE LABEL
SENSODYNE PRONAMEL
Does not contain: SLS/sulfates • artificial dyes • parabens • triclosan • peroxide
Acidic foods and drinks can cause enamel loss that can lead to yellowing, dullness and sensitivity. Pronamel has a specialty formulation to help rebuild and restore acid weakened enamel, helping prevent enamel loss for strong, healthy teeth.
ACID ATTACKS ENAMEL
WEAKENING THE ENAMEL STRUCTURE
PRONAMEL REBUILDS & RESTORES ENAMEL
FOR STRONG HEALTHY TEETH
Healthy white teeth start with strong enamel.
Pronamel has a proven specialist technology that has been developed to maximize the effect of fluoride on enamel.
With twice-daily brushing,
Pronamel helps to:
- Rebuild enamel strength for strong, healthy teeth
- Protect against the effects of dietary acids
- Relieve sensitive teeth
- Freshen breath
- Protect against cavities
Recycle Carton, Tube and Cap†
Save Water Turn off tap while brushing
†Recycling facilities for this product may not exist in your area
Distributed by:
GSK Consumer Healthcare
Warren, NJ 07059
Trademarks are owned by or licensed to the GSK group of companies.
©2021 GSK group of companies or its licensor.
62000000068910 Front Carton
Principal Display Panel
NDC 0135-0568-04
SENSODYNE
PRONAMEL
TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION
Cleansing Mint
MULTI-ACTION
Specialist Enamel Protection
Rebuilds, Restores, Refreshes
NET WT 4.0 OZ (113 g)
ALWAYS FOLLOW THE LABEL
SENSODYNE PRONAMEL
Does not contain: SLS/sulfates • artificial dyes • parabens • triclosan • peroxide
Acidic foods and drinks can cause enamel loss that can lead to yellowing, dullness and sensitivity. Pronamel has a specialty formulation to help rebuild and restore acid weakened enamel, helping prevent enamel loss for strong, healthy teeth.
ACID ATTACKS ENAMEL
WEAKENING THE ENAMEL STRUCTURE
PRONAMEL REBUILDS & RESTORES ENAMEL
FOR STRONG HEALTHY TEETH
Healthy white teeth start with strong enamel.
Pronamel has a proven specialist technology that has been developed to maximize the effect of fluoride on enamel.
With twice-daily brushing,
Pronamel helps to:
- Rebuild enamel strength for strong, healthy teeth
- Protect against the effects of dietary acids
- Relieve sensitive teeth
- Freshen breath
- Protect against cavities
Recycle Carton, Tube and Cap†
Save Water Turn off tap while brushing
Distributed by:
GSKConsumer Healthcare
Warren, NJ 07059
Trademarks are owned by or licensed to the GSK group of companies.
©2021 GSK group of companies or its licensor.
62000000069352 Front Carton
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1086243 | potassium nitrate 5 % / sodium fluoride 0.25 % Toothpaste | PSN | 21 |
| 1086243 | potassium nitrate 0.05 MG/MG / sodium fluoride 0.0025 MG/MG Toothpaste | SCD | 21 |
| 1086243 | K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG Toothpaste | SY | 21 |
| 1086243 | Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG Toothpaste | SY | 21 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0135-0460-01 | SENSODYNE PRONAMELDaily Protection | 1 in 1 CARTON | PASTE | 1 | 21 | |
| 0135-0460-01 | SENSODYNE PRONAMELDaily Protection | 113 g in 1 TUBE | PASTE | 113 | 21 | |
| 0135-0460-03 | SENSODYNE PRONAMELDaily Protection | 1 in 1 CARTON | PASTE | 1 | 21 | |
| 0135-0460-03 | SENSODYNE PRONAMELDaily Protection | 184.3 g in 1 TUBE | PASTE | 184.3 | 21 | |
| 0135-0460-06 | SENSODYNE PRONAMELDaily Protection | 2 in 1 CARTON | PASTE | 2 | 21 | |
| 0135-0460-06 | SENSODYNE PRONAMELDaily Protection | 113 g in 1 TUBE | PASTE | 113 | 21 | |
| 0135-0484-01 | SENSODYNE PRONAMELGentle Whitening | 1 in 1 CARTON | PASTE | 1 | 21 | |
| 0135-0484-01 | SENSODYNE PRONAMELGentle Whitening | 113 g in 1 TUBE | PASTE | 113 | 21 | |
| 0135-0484-02 | SENSODYNE PRONAMELGentle Whitening | 1 in 1 CARTON | PASTE | 1 | 21 | |
| 0135-0484-02 | SENSODYNE PRONAMELGentle Whitening | 76.5 g in 1 TUBE | PASTE | 76.5 | 21 | |
| 0135-0484-03 | SENSODYNE PRONAMELGentle Whitening | 22.6 g in 1 TUBE | PASTE | 22.6 | 21 | |
| 0135-0484-04 | SENSODYNE PRONAMELGentle Whitening | 1 in 1 CARTON | PASTE | 1 | 21 | |
| 0135-0484-04 | SENSODYNE PRONAMELGentle Whitening | 184.3 g in 1 TUBE | PASTE | 184.3 | 21 | |
| 0135-0484-05 | SENSODYNE PRONAMELGentle Whitening | 2 in 1 CARTON | PASTE | 2 | 21 | |
| 0135-0484-05 | SENSODYNE PRONAMELGentle Whitening | 113 g in 1 TUBE | PASTE | 113 | 21 | |
| 0135-0484-06 | SENSODYNE PRONAMELGentle Whitening | 184.3 g in 1 TUBE | PASTE | 184.3 | 21 | |
| 0135-0484-06 | SENSODYNE PRONAMELGentle Whitening | 4 in 1 CARTON | PASTE | 4 | 21 | |
| 0135-0520-01 | SENSODYNE PRONAMELFresh Breath | 1 in 1 CARTON | PASTE | 1 | 21 | |
| 0135-0520-01 | SENSODYNE PRONAMELFresh Breath | 113 g in 1 TUBE | PASTE | 113 | 21 | |
| 0135-0520-02 | SENSODYNE PRONAMELFresh Breath | 23 g in 1 TUBE | PASTE | 23 | 21 | |
| 0135-0520-05 | SENSODYNE PRONAMELFresh Breath | 2 in 1 CARTON | PASTE | 2 | 21 | |
| 0135-0520-05 | SENSODYNE PRONAMELFresh Breath | 113 g in 1 TUBE | PASTE | 113 | 21 | |
| 0135-0520-06 | SENSODYNE PRONAMELFresh Breath | 1 in 1 CARTON | PASTE | 1 | 21 | |
| 0135-0520-06 | SENSODYNE PRONAMELFresh Breath | 77 g in 1 TUBE | PASTE | 77 | 21 | |
| 0135-0568-04 | SENSODYNE PRONAMELMulti Action | 113 g in 1 TUBE | PASTE | 113 | 21 | |
| 0135-0568-04 | SENSODYNE PRONAMELMulti Action | 1 in 1 CARTON | PASTE | 1 | 21 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0135-0460 | SENSODYNE PRONAMEL GENTLE WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE PRONAMEL DAILY PROTECTION (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE PRONAMEL FRESH BREATH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE PRONAMEL MULTI ACTION (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC] | 21 | Current NDC, Legacy NDC, 6 package rows | 20240125_edffce4d-108b-4ffd-9adf-e12cb42ffddd.zip |
| 0135-0484 | SENSODYNE PRONAMEL GENTLE WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE PRONAMEL DAILY PROTECTION (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE PRONAMEL FRESH BREATH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE PRONAMEL MULTI ACTION (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC] | 21 | Current NDC, Legacy NDC, 11 package rows | 20240125_edffce4d-108b-4ffd-9adf-e12cb42ffddd.zip |
| 0135-0520 | SENSODYNE PRONAMEL GENTLE WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE PRONAMEL DAILY PROTECTION (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE PRONAMEL FRESH BREATH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE PRONAMEL MULTI ACTION (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC] | 21 | Current NDC, Legacy NDC, 7 package rows | 20240125_edffce4d-108b-4ffd-9adf-e12cb42ffddd.zip |
| 0135-0568 | SENSODYNE PRONAMEL GENTLE WHITENING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE PRONAMEL DAILY PROTECTION (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE PRONAMEL FRESH BREATH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE SENSODYNE PRONAMEL MULTI ACTION (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC] | 21 | Current NDC, Legacy NDC, 2 package rows | 20240125_edffce4d-108b-4ffd-9adf-e12cb42ffddd.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0135-0484-02 | GM - Gram | 0135-0484 | 66d6ea4d-2c37-4d94-86ec-bf5e3493d44a | 1 | 2025-09-12 |
| 0135-0484-03 | GM - Gram | 0135-0484 | 724e25a8-6f21-4997-af71-c3dcc76b0fca | 1 | 2024-09-09 |
| 0135-0460-01 | GM - Gram | 0135-0460 | 941b8275-1b21-4ad5-8675-3fb9141a592f | 1 | 2024-04-05 |
| 0135-0460-06 | GM - Gram | 0135-0460 | b9f84b83-39fd-42e0-a6d3-9446f436c531 | 1 | 2025-07-08 |
| 0135-0520-01 | GM - Gram | 0135-0520 | c2190fd7-ded1-4129-bfa5-02973c82f4f1 | 1 | 2024-04-05 |
| 0135-0520-02 | GM - Gram | 0135-0520 | 50f8a8c0-580c-4557-97bf-559cd008aedb | 1 | 2024-04-05 |
| 0135-0520-05 | GM - Gram | 0135-0520 | 6fce3414-6b80-48bd-9898-34b66c7bff9f | 1 | 2024-04-05 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| POTASSIUM NITRATE | ACTIVE INGREDIENT | RU45X2JN0Z | 10 | |
| SODIUM FLUORIDE | ACTIVE INGREDIENT | 8ZYQ1474W7 | 10 | |
| FLUORIDE ION | ACTIVE MOIETY | Q80VPU408O | 10 | |
| NITRATE ION | ACTIVE MOIETY | T93E9Y2844 | 10 | |
| COCAMIDOPROPYL BETAINE | INACTIVE INGREDIENT | 5OCF3O11KX | 10 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 10 | |
| HYDRATED SILICA | INACTIVE INGREDIENT | Y6O7T4G8P9 | 10 | |
| MICA | INACTIVE INGREDIENT | V8A1AW0880 | 10 | |
| POLYETHYLENE GLYCOL 400 | INACTIVE INGREDIENT | B697894SGQ | 10 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | 10 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | 10 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 10 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 10 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 10 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | 10 |
Products#
Every source-derived product name is available through these pages.
- SENSODYNE PRONAMEL Gentle Whitening
- potassium nitrate and sodium fluoride
- WATER
- SORBITOL
- HYDRATED SILICA
- GLYCERIN
- POLYETHYLENE GLYCOL 400
- COCAMIDOPROPYL BETAINE
- TITANIUM DIOXIDE
- XANTHAN GUM
- SACCHARIN SODIUM
- SODIUM HYDROXIDE
- POTASSIUM NITRATE
- NITRATE ION
- SODIUM FLUORIDE
- FLUORIDE ION
- SENSODYNE PRONAMEL Daily Protection
- SENSODYNE PRONAMEL Fresh Breath
- SENSODYNE PRONAMEL Multi Action
- MICA
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0135-0484 | 0135-0484-01, 0135-0484-05, 0135-0484-02, 0135-0484-03, 0135-0484-04, 0135-0484-06 |
| 0135-0460 | 0135-0460-01, 0135-0460-06, 0135-0460-03 |
| 0135-0520 | 0135-0520-01, 0135-0520-02, 0135-0520-05, 0135-0520-06 |
| 0135-0568 | 0135-0568-04 |
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 |
|---|---|---|---|---|---|---|
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED / ORAL | 17 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED PELLETS / ORAL | 4.4 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE / ORAL | 3822 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, COATED / ORAL | 49 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET / ORAL | 193 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 11 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | PASTE / ORAL | 3 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | PASTE / ORAL | 3822 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SUSPENSION / ORAL | 45000 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | CAPSULE / ORAL | 60 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, DELAYED RELEASE / ORAL | 0.01 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | CAPSULE, LIQUID FILLED / ORAL | 1122 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, FILM COATED / ORAL | 5 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | DROPS / ORAL | NA | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | PASTE / DENTAL | 0.6 %w/w | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | FILM, SOLUBLE / ORAL | 11 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE / ORAL | 55 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, FILM COATED / ORAL | 36 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | CAPSULE / ORAL | 1111 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SYRUP / ORAL | 4370 mg/5ml | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | EMULSION / ORAL | ADJ PH | ||
| XANTHAN GUM | XANTHAN GUM | TTV12P4NEE | PASTE / ORAL | 1050 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | TABLET, COATED / ORAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING / ORAL | 6 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET, ORALLY DISINTEGRATING / ORAL | 2 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 24 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | SUSPENSION / ORAL | 45000 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUSPENSION / ORAL | 113 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SOLUTION, CONCENTRATE / ORAL | 2813 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / ORAL | 72 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | POWDER, FOR SUSPENSION / ORAL | 9 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | TABLET, COATED / ORAL | NA | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | FILM, SOLUBLE / ORAL | 29 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, LIQUID FILLED / ORAL | 12 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, ORALLY DISINTEGRATING / ORAL | 7 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | CAPSULE, DELAYED RELEASE / ORAL | 26 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION / ORAL | 400 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | PASTE / ORAL | 3 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | TABLET, DELAYED RELEASE / ORAL | 4 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, FILM COATED / ORAL | 5 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | GRANULE, FOR SUSPENSION / ORAL | 143 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | CAPSULE, DELAYED RELEASE / ORAL | 26 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET, EXTENDED RELEASE / ORAL | 60 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | DROPS / ORAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SUSPENSION / ORAL | 113 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION / ORAL | 400 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | PASTE / DENTAL | 14.6 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | DROPS / ORAL | NA | ||
| SORBITOL | SORBITOL | 506T60A25R | LIQUID / ORAL | 53460 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | PASTE / DENTAL | 14.6 %w/w | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | POWDER, FOR SOLUTION / ORAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | CAPSULE, COATED PELLETS / ORAL | 0.01 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SUSPENSION / ORAL | 400 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | SOLUTION / ORAL | 70200 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, FILM COATED / ORAL | 5 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | GRANULE, FOR SUSPENSION / ORAL | ADJ PH | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | CAPSULE / ORAL | 13440 mg | ||
| SORBITOL | SORBITOL | 506T60A25R | TABLET, EXTENDED RELEASE / ORAL | 428 mg | ||
| POLYETHYLENE GLYCOL 400 | POLYETHYLENE GLYCOL 400 | B697894SGQ | TABLET, DELAYED RELEASE / ORAL | 35 mg |
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 |
|---|---|---|---|---|---|---|
| SENSODYNE PRONAMEL Daily Protection | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | edffce4d-108b-4ffd-9adf-e12cb42ffddd | 2024-01-24 | Warnings | 0135-0460-03 0135-0484-02 0135-0520-02 0135-0520-06 0135-0484-05 0135-0484-03 0135-0460-01 0135-0484-06 0135-0520-05 0135-0520-01 0135-0484-04 0135-0460-06 0135-0484-01 0135-0568-04 0135-0460 0135-0568 0135-0484 0135-0520 00135048403 00135048405 00135048404 00135052001 00135056804 00135048402 00135046001 00135052005 00135046003 00135046006 00135052006 00135052002 00135048401 00135048406 0fb8d5cd-17d5-f0ac-e063-6394a90ab28d edffce4d-108b-4ffd-9adf-e12cb42ffddd |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.