Colgate

Manufacturer
Colgate-Palmolive Company | Colgate-Palmolive
Effective date
2019-12-11
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 23:52:18

Label at a glance#

ProductColgate Total Clean Mint
Active ingredientSODIUM FLUORIDE, TRICLOSAN
Label structure9 sections

Indications and uses

aids in the prevention of: cavities plaque gingivitis

Dosage and administration

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...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Sodium fluoride 0.24% (0.14% w/v fluoride ion)Anticavity
Triclosan 0.30%Antigingivitis

Uses

INDICATIONS & USAGE SECTION

aids in the prevention of:

  • cavities
  • plaque
  • gingivitis

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

OTC - ASK DOCTOR SECTION

Ask a dentist before use if you have

  • bleeding or redness lasting more than 2 weeks
  • pain, swelling, pus, loose teeth, or more spacing between teeth

These may be signs of periodontitis, a serious form of gum disease.

Directions

DOSAGE & ADMINISTRATION SECTION

supervise children as necessary until capable of using without supervision.

adults and children 6 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a physician
children under 12 yearsinstruct in good brushing and rinsing habits
(to minimize swallowing)
children under 6 yearsdo not use unless directed by a dentist or a physician

Antiplaque and antigingivitis use not proven in children.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, hydrated silica, glycerin, sorbitol, PVM/MA copolymer, sodium lauryl sulfate, cellulose gum, flavor, sodium hydroxide, propylene glycol, carrageenan, sodium saccharin, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call toll-free 1-800-468-6502

SPL UNCLASSIFIED SECTION

Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022

www.colgatetotal.com

PRINCIPAL DISPLAY PANEL - 221 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW
STAND-UP
CAP

Helps Prevent Cavities • Gingivitis • Plaque
Fights Tartar • Freshens Breath • Gently Cleans

Colgate®
Anticavity Fluoride and Antigingivitis Toothpaste

Total®

Clean Mint Paste

ADA
Accepted
American
Dental
Association ®

NET WT 7.8 OZ (221 g)

Principal Display Panel - 221 g Tube Carton
Principal Display Panel - 221 g Tube Carton

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Silicon DioxideACTIVE INGREDIENTETJ7Z6XBU43
Sodium FluorideACTIVE INGREDIENT8ZYQ1474W73
TriclosanACTIVE INGREDIENT4NM5039Y5X3
Fluoride IonACTIVE MOIETYQ80VPU408O3
Silicon DioxideACTIVE MOIETYETJ7Z6XBU43
TriclosanACTIVE MOIETY4NM5039Y5X3
carboxymethylcellulose sodiumINACTIVE INGREDIENTK679OBS3113
carrageenanINACTIVE INGREDIENT5C69YCD2YJ3
glycerinINACTIVE INGREDIENTPDC6A3C0OX3
hydrated silicaINACTIVE INGREDIENTY6O7T4G8P93
propylene glycolINACTIVE INGREDIENT6DC9Q167V33
saccharin sodiumINACTIVE INGREDIENTSB8ZUX40TY3
sodium hydroxideINACTIVE INGREDIENT55X04QC32I3
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141J3
sorbitolINACTIVE INGREDIENT506T60A25R3
titanium dioxideINACTIVE INGREDIENT15FIX9V2JP3
waterINACTIVE INGREDIENT059QF0KO0R3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
35000-02135000-021-85, 35000-021-16, 35000-021-71, 35000-021-60, 35000-021-78, 35000-021-99, 35000-021-34

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML · Source PDF

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.

Inactive ingredient links page 1 of 10 · 544 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
sodium hydroxideSODIUM HYDROXIDE55X04QC32ILIQUID / ORAL2 mg/5mlExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / RECTALNAExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRALESIONALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUPPOSITORY / RECTAL440 mgExact identifier — unii candidate
75 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JSHAMPOO / TOPICAL65 %w/wExact identifier — unii candidate
42 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXMOUTHWASH / BUCCAL100 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ICAPSULE, DELAYED RELEASE / ORAL0.25 mgExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISPRAY, METERED / NASALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SOLUTION/ DROPS / OPHTHALMIC2 mgExact identifier — unii candidate
44 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
sorbitolSORBITOL506T60A25RGUM, CHEWING / BUCCAL5110 mgExact identifier — unii candidate
44 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / INTRAVITREALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IGEL, METERED / TRANSDERMAL350 mgExact identifier — unii candidate
174 equally ranked IID candidates
sorbitolSORBITOL506T60A25RPASTE / DENTAL14.6 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JGEL / DENTAL1.47 %w/wExact identifier — unii candidate
42 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JCAPSULE, EXTENDED RELEASE / ORAL166 mgExact identifier — unii candidate
42 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3TABLET, COATED / ORAL16 mgExact identifier — unii candidate
81 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3INJECTION / INTRAVENOUS16624 mgExact identifier — unii candidate
81 equally ranked IID candidates
sorbitolSORBITOL506T60A25RINJECTION / INTRASYNOVIAL45 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRACAUDALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPOINTMENT / TOPICAL5 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JTABLET, CHEWABLE / ORAL6 mgExact identifier — unii candidate
42 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / INTRAOCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / SUBCUTANEOUS1 %w/vExact identifier — unii candidate
174 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3PASTE / DENTAL0.5 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32ICREAM / VAGINAL0.19 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IPOWDER, FOR SUSPENSION / ORAL9 mgExact identifier — unii candidate
174 equally ranked IID candidates
saccharin sodiumSACCHARIN SODIUMSB8ZUX40TYWAFER / ORAL8 mgExact identifier — unii candidate
34 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPSHAMPOO, SUSPENSION / TOPICAL3 %w/vExact identifier — unii candidate
40 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii candidate
75 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IEMULSION / OPHTHALMIC0.02 %w/vExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311SYRUP / ORAL26.5 mgExact identifier — unii candidate
44 equally ranked IID candidates
sorbitolSORBITOL506T60A25RTABLET, DELAYED RELEASE / ORAL0.01 mgExact identifier — unii candidate
44 equally ranked IID candidates
carrageenanCARRAGEENAN5C69YCD2YJCAPSULE / ORAL3 mgExact identifier — unii candidate
10 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSHAMPOO / TOPICAL5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / INTRA-ARTERIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
saccharin sodiumSACCHARIN SODIUMSB8ZUX40TYOINTMENT / DENTALNAExact identifier — unii candidate
34 equally ranked IID candidates
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMK679OBS311INJECTION, SUSPENSION / SOFT TISSUE15 mgExact identifier — unii candidate
44 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JGRANULE / ORAL12 mgExact identifier — unii candidate
42 equally ranked IID candidates
titanium dioxideTITANIUM DIOXIDE15FIX9V2JPTABLET, ORALLY DISINTEGRATING / ORAL6 mgExact identifier — unii candidate
40 equally ranked IID candidates
saccharin sodiumSACCHARIN SODIUMSB8ZUX40TYOINTMENT / TOPICALNAExact identifier — unii candidate
34 equally ranked IID candidates
saccharin sodiumSACCHARIN SODIUMSB8ZUX40TYTABLET, FOR SUSPENSION / ORAL6 mgExact identifier — unii candidate
34 equally ranked IID candidates
saccharin sodiumSACCHARIN SODIUMSB8ZUX40TYTABLET / SUBLINGUAL7 mgExact identifier — unii candidate
34 equally ranked IID candidates
sorbitolSORBITOL506T60A25RINJECTION / SUBCUTANEOUS4.7 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3DROPS / ORAL200 mg/1mlExact identifier — unii candidate
81 equally ranked IID candidates
sorbitolSORBITOL506T60A25RLOTION / TOPICAL10.7 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
propylene glycolPROPYLENE GLYCOL6DC9Q167V3EMULSION / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SOLUTION / INTRATHECALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, SUSPENSION / INTRAMUSCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUSPENSION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRADERMALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IGEL / TRANSDERMAL472 mgExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / SUBCUTANEOUS31.45 mgExact identifier — unii candidate
174 equally ranked IID candidates
sodium hydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR0.35 %w/vExact identifier — unii candidate
174 equally ranked IID candidates
sorbitolSORBITOL506T60A25RCONCENTRATE / ORAL600 mg/1mlExact identifier — unii candidate
44 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020231-001COLGATE TOTALSODIUM FLUORIDE; TRICLOSAN0.24%;0.3%PASTE / DENTALRLD1997-07-11

Observed Orange Book product history#

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-1184e616aacf4f…
2026-08-18 06:07:402026-07N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-1187673890dc5c…
2021-03-12 10:30 UTC2021-03N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-118869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-11c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-113f01610625f2…
2019-09-15 20:21 UTC2019-09N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-11b00525d2431f…
2019-07-19 19:46 UTC2019-07N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-111c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-113f0d92c62455…
2023-05-13 08:27 UTC2023-05N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-11053a50430f4f…
2023-01-26 05:58 UTC2023-01N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020231-001COLGATE TOTAL0.24%;0.3%PASTE / DENTALRLD1997-07-11f41ea6bd6efb…

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
10f69d8b-de0d-4a74-ba9c-04f1ffd44f01319fc2ff-b86f-4162-acf6-a53716f4fe1e2019-12-11WarningsExact identifier
spl set id: 319fc2ff-b86f-4162-acf6-a53716f4fe1e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.