Indications and uses
Aids in the prevention of: cavities plaque gingivitis
Aids in the prevention of: cavities plaque gingivitis
supervise children as necessary until capable of using without supervision. adults and children 6 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a physician children under 12 years instruct in good brushing and rinsing habits (to minimize swallowing) children under 6 years do not use unless directed by a dentist or a physician Antip...
Sodium Fluoride 0.24% (0.14% W/V Fluoride Ion)
Triclosan 0.30%
Anticavity
Antigingivitis
Aids in the prevention of:
Keep out of the reach of children under 6 years of age.
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Ask a dentist before use if you have
These may be signs of peridontitis , a serious form of gum disease.
supervise children as necessary until capable of using without supervision.
| adults and children 6 years of age and older | brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a physician |
| children under 12 years | instruct in good brushing and rinsing habits
(to minimize swallowing) |
| children under 6 years | do not use unless directed by a dentist or a physician
|
Antiplaque and antigingivitis use not proven in children.
water, hydrated silica, glycerin, sorbitol, PVM/MA copolymer, sodium lauryl sulfate, cellulose gum, flavor, sodium hydroxide, carrageenan, propylene glycol, sodium saccharin, titanium dioxide.
Call toll-free
1-800-468-6502 or visit
www.colgate.com
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| SODIUM FLUORIDE | ACTIVE INGREDIENT | 8ZYQ1474W7 | 4 | |
| TRICLOSAN | ACTIVE INGREDIENT | 4NM5039Y5X | 4 | |
| FLUORIDE ION | ACTIVE MOIETY | Q80VPU408O | 4 | |
| TRICLOSAN | ACTIVE MOIETY | 4NM5039Y5X | 4 | |
| CARBOXYMETHYLCELLULOSE SODIUM | INACTIVE INGREDIENT | K679OBS311 | 4 | |
| CARRAGEENAN | INACTIVE INGREDIENT | 5C69YCD2YJ | 4 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | 4 | |
| HYDRATED SILICA | INACTIVE INGREDIENT | Y6O7T4G8P9 | 4 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 4 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | 4 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | 4 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | 4 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 4 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 4 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 67751-131 | 67751-131-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| HYDRATED SILICA | Y6O7T4G8P9 | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| SORBITOL | 506T60A25R | IACT |
| SODIUM LAURYL SULFATE | 368GB5141J | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| CARRAGEENAN | 5C69YCD2YJ | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| SODIUM FLUORIDE | 8ZYQ1474W7 | ACTIM |
| TRICLOSAN | 4NM5039Y5X | ACTIB |
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 |
|---|---|---|---|---|---|---|
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / TOPICAL | 4522 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / DENTAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SOLUTION / INTRADISCAL | ADJ PH | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | SHAMPOO, SUSPENSION / TOPICAL | 3 %w/v | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SOLUTION / INTRATHECAL | ADJ PH | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, DELAYED RELEASE / ORAL | 1.7 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INFILTRATION | ADJ PH | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | TABLET / PERIODONTAL | 0.53 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | CAPSULE, EXTENDED RELEASE / ORAL | 265 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / INTRAMUSCULAR | 7459 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION, CONCENTRATE / INTRAVENOUS | 50.33 %w/v | ||
| SORBITOL | SORBITOL | 506T60A25R | PASTE / DENTAL | 14.6 %w/w | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | PELLET / ORAL | 2 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS | ADJ PH | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | LOTION / TOPICAL | 111 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LOTION / TOPICAL | 3990 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / VAGINAL | 750 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION, EXTENDED RELEASE / INTRASYNOVIAL | ADJ PH | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | CAPSULE / ORAL | 600 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | FILM, EXTENDED RELEASE / BUCCAL | 34 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | FILM / BUCCAL | 18 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | EMULSION / INTRAVENOUS | 2.2 %w/v | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | DISC / TOPICAL | ADJ PH | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | POWDER / VAGINAL | 3 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | TABLET / RECTAL | 0.6 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | SOLUTION/ DROPS / OPHTHALMIC | 12 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | FILM / BUCCAL | 3 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION / OPHTHALMIC | ADJ PH | ||
| SORBITOL | SORBITOL | 506T60A25R | GUM, CHEWING / ORAL | 6168 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | GEL / DENTAL | 0.4 %w/w | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SOLUTION / RECTAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / NASAL | 20 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | AEROSOL, FOAM / TOPICAL | 21 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | ELIXIR / ORAL | 5621 mg | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 3 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| SODIUM LAURYL SULFATE | SODIUM LAURYL SULFATE | 368GB5141J | TABLET / BUCCAL | 5.18 mg | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | SYSTEM / TOPICAL | 1680 mg | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | LIQUID / ORAL | 2400 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | LIQUID / TOPICAL | ADJ PH | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRASYNOVIAL | 45 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / TRANSDERMAL | 500 mg | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | PASTE, DENTIFRICE / DENTAL | 0.2 %w/w | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | MOUTHWASH / BUCCAL | 2 mg/1ml | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION/ DROPS / OPHTHALMIC | ADJ PH | ||
| GLYCERIN | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / INTRAMUSCULAR | 15 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / OPHTHALMIC | 0.44 %w/w | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRABURSAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRADERMAL | ADJ PH | ||
| SACCHARIN SODIUM | SACCHARIN SODIUM | SB8ZUX40TY | TABLET, CHEWABLE / ORAL | 84 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | GEL / TRANSDERMAL | 472 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SPONGE / TOPICAL | ADJ PH | ||
| SORBITOL | SORBITOL | 506T60A25R | INJECTION / INTRAVENOUS | 1276 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / EPIDURAL | ADJ PH | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE / ORAL | 72 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION / AURICULAR (OTIC) | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRAVASCULAR | ADJ PH | ||
| CARRAGEENAN | CARRAGEENAN | 5C69YCD2YJ | POWDER / NASAL | NA | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION/ DROPS / AURICULAR (OTIC) | ADJ PH | ||
| CARBOXYMETHYLCELLULOSE SODIUM | CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | INJECTION, SUSPENSION / INTRAMUSCULAR | 30 mg |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020231-001 | COLGATE TOTAL | SODIUM FLUORIDE; TRICLOSAN | 0.24%;0.3% | PASTE / DENTAL | RLD | 1997-07-11 |
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N020231-001 | COLGATE TOTAL | 0.24%;0.3% | PASTE / DENTAL | RLD | 1997-07-11 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N020231-001 | COLGATE TOTAL | 0.24%;0.3% | PASTE / DENTAL | RLD | 1997-07-11 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N020231-001 | COLGATE TOTAL | 0.24%;0.3% | PASTE / DENTAL | RLD | 1997-07-11 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020231-001 | COLGATE TOTAL | 0.24%;0.3% | PASTE / DENTAL | RLD | 1997-07-11 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020231-001 | COLGATE TOTAL | 0.24%;0.3% | PASTE / DENTAL | RLD | 1997-07-11 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020231-001 | COLGATE TOTAL | 0.24%;0.3% | PASTE / DENTAL | RLD | 1997-07-11 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020231-001 | COLGATE TOTAL | 0.24%;0.3% | PASTE / DENTAL | RLD | 1997-07-11 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020231-001 | COLGATE TOTAL | 0.24%;0.3% | PASTE / DENTAL | RLD | 1997-07-11 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020231-001 | COLGATE TOTAL | 0.24%;0.3% | PASTE / DENTAL | RLD | 1997-07-11 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020231-001 | COLGATE TOTAL | 0.24%;0.3% | PASTE / DENTAL | RLD | 1997-07-11 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020231-001 | COLGATE TOTAL | 0.24%;0.3% | PASTE / DENTAL | RLD | 1997-07-11 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020231-001 | COLGATE TOTAL | 0.24%;0.3% | PASTE / DENTAL | RLD | 1997-07-11 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020231-001 | COLGATE TOTAL | 0.24%;0.3% | PASTE / DENTAL | RLD | 1997-07-11 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020231-001 | COLGATE TOTAL | 0.24%;0.3% | PASTE / DENTAL | RLD | 1997-07-11 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020231-001 | COLGATE TOTAL | 0.24%;0.3% | PASTE / DENTAL | RLD | 1997-07-11 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020231-001 | COLGATE TOTAL | 0.24%;0.3% | PASTE / DENTAL | RLD | 1997-07-11 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020231-001 | COLGATE TOTAL | 0.24%;0.3% | PASTE / DENTAL | RLD | 1997-07-11 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020231-001 | COLGATE TOTAL | 0.24%;0.3% | PASTE / DENTAL | RLD | 1997-07-11 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020231-001 | COLGATE TOTAL | 0.24%;0.3% | PASTE / DENTAL | RLD | 1997-07-11 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020231-001 | COLGATE TOTAL | 0.24%;0.3% | PASTE / DENTAL | RLD | 1997-07-11 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020231-001 | COLGATE TOTAL | 0.24%;0.3% | PASTE / DENTAL | RLD | 1997-07-11 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N020231-001 | COLGATE TOTAL | 0.24%;0.3% | PASTE / DENTAL | RLD | 1997-07-11 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N020231-001 | COLGATE TOTAL | 0.24%;0.3% | PASTE / DENTAL | RLD | 1997-07-11 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020231-001 | COLGATE TOTAL | 0.24%;0.3% | PASTE / DENTAL | RLD | 1997-07-11 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N020231-001 | COLGATE TOTAL | 0.24%;0.3% | PASTE / DENTAL | RLD | 1997-07-11 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N020231-001 | COLGATE TOTAL | 0.24%;0.3% | PASTE / DENTAL | RLD | 1997-07-11 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N020231-001 | COLGATE TOTAL | 0.24%;0.3% | PASTE / DENTAL | RLD | 1997-07-11 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N020231-001 | COLGATE TOTAL | 0.24%;0.3% | PASTE / DENTAL | RLD | 1997-07-11 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N020231-001 | COLGATE TOTAL | 0.24%;0.3% | PASTE / DENTAL | RLD | 1997-07-11 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N020231-001 | COLGATE TOTAL | 0.24%;0.3% | PASTE / DENTAL | RLD | 1997-07-11 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N020231-001 | COLGATE TOTAL | 0.24%;0.3% | PASTE / DENTAL | RLD | 1997-07-11 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N020231-001 | COLGATE TOTAL | 0.24%;0.3% | PASTE / DENTAL | RLD | 1997-07-11 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N020231-001 | COLGATE TOTAL | 0.24%;0.3% | PASTE / DENTAL | RLD | 1997-07-11 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N020231-001 | COLGATE TOTAL | 0.24%;0.3% | PASTE / DENTAL | RLD | 1997-07-11 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N020231-001 | COLGATE TOTAL | 0.24%;0.3% | PASTE / DENTAL | RLD | 1997-07-11 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N020231-001 | COLGATE TOTAL | 0.24%;0.3% | PASTE / DENTAL | RLD | 1997-07-11 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N020231-001 | COLGATE TOTAL | 0.24%;0.3% | PASTE / DENTAL | RLD | 1997-07-11 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N020231-001 | COLGATE TOTAL | 0.24%;0.3% | PASTE / DENTAL | RLD | 1997-07-11 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N020231-001 | COLGATE TOTAL | 0.24%;0.3% | PASTE / DENTAL | RLD | 1997-07-11 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N020231-001 | COLGATE TOTAL | 0.24%;0.3% | PASTE / DENTAL | RLD | 1997-07-11 | 3a93d1ddd44b… |
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 |
|---|---|---|---|---|---|---|
| 97521927-60ac-6b20-e053-2a95a90ae353 | 91b607d3-43e9-4256-8ec0-42c2fd25106a | 2019-11-14 | Warnings | 97521927-60ac-6b20-e053-2a95a90ae353 91b607d3-43e9-4256-8ec0-42c2fd25106a |
Adverse event summaries are temporarily unavailable. Other product information remains available.