Gel-Kam Fruit and Berry

Manufacturer
Colgate Oral Pharmaceuticals, Inc.
Effective date
2024-01-18
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
full-release
Hydrated at
2026-06-01 00:07:34

Label at a glance#

ProductGel-Kam Mint
Active ingredientSTANNOUS FLUORIDE
Label structure11 sections

Indications and uses

helps protect against cavities builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact

Dosage and administration

adults and children 12 years of age or older: use after regular brushing and flossing shake excess water from your toothbrush and cover bristles with gel brush thoroughly keep on your teeth for one minute and then spit out do not swallow do not rinse, eat or drink for 30 minutes use once a day for cavity protection use twice a day (morning and evening) for sensitivity relief or as recommended by a dentist or physi...

Storage and handling

this is a fluoride preventive treatment gel, not a toothpaste. Read directions carefully before use this product may produce surface staining of the teeth Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist do not use if embossed seal on tube is broken or missing to open tube, remove cap and pierce foil seal with point of cap keep tightly closed whe...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Stannous fluoride 0.4% (w/w)

Purposes

OTC - PURPOSE SECTION

Anticavity/Sensitivity Relief

Uses

INDICATIONS & USAGE SECTION

  • helps protect against cavities
  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use this product longer than four weeks for sensitive teeth unless recommended by a dentist or physician.

OTC - STOP USE SECTION

Stop use and ask a doctor if problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years of age or older: use after regular brushing and flossing
  • shake excess water from your toothbrush and cover bristles with gel
  • brush thoroughly
  • keep on your teeth for one minute and then spit out
  • do not swallow
  • do not rinse, eat or drink for 30 minutes
  • use once a day for cavity protection
  • use twice a day (morning and evening) for sensitivity relief or as recommended by a dentist or physician
  • make sure all sensitive areas are covered by using a toothbrush or a cotton swab
  • supervise children until capable of using without supervision
  • children under 12 years of age: consult a dentist or physician

Other information

STORAGE AND HANDLING SECTION

  • this is a fluoride preventive treatment gel, not a toothpaste. Read directions carefully before use
  • this product may produce surface staining of the teeth Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist
  • do not use if embossed seal on tube is broken or missing
  • to open tube, remove cap and pierce foil seal with point of cap
  • keep tightly closed when not in use
  • store at controlled room temperature 68-77°F (20-25°C)

Inactive ingredients

INACTIVE INGREDIENT SECTION

flavor, glycerin, hydroxyethylcellulose

Questions or comments?

OTC - QUESTIONS SECTION

call toll free at 1-800-962-2345

PRINCIPAL DISPLAY PANEL - 122 g Tube Carton - Mint

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0126-0192-93

Colgate®

Gel•Kam®

0.4% Stable Stannous Fluoride
PREVENTATIVE TREATMENT GEL
For Cavity Protection and Sensitive Teeth
MINT

NET WT 4.3 OZ (122 g)

PRINCIPAL DISPLAY PANEL - 122 g Tube Carton - Mint
PRINCIPAL DISPLAY PANEL - 122 g Tube Carton - Mint

PRINCIPAL DISPLAY PANEL - 122 g Tube Carton - Fruit and Berry

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0126-0165-93

Colgate®

Gel•Kam®

0.4% Stable Stannous Fluoride
PREVENTATIVE TREATMENT GEL
For Cavity Protection and Sensitive Teeth
FRUIT & BERRY

NET WT 4.3 OZ (122 g)

PRINCIPAL DISPLAY PANEL - 122 g Tube Carton - Fruit and Berry
PRINCIPAL DISPLAY PANEL - 122 g Tube Carton - Fruit and Berry

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
750088Gel-Kam 0.4 % Oral GelPSN13
237847stannous fluoride 0.4 % Oral GelPSN13
750088stannous fluoride 0.004 MG/MG Oral Gel [Gel-Kam]SBD13
237847stannous fluoride 0.004 MG/MG Oral GelSCD13
750088Gel-Kam 0.004 MG/MG Oral GelSY13
750088Gel-Kam 0.4 % Oral GelSY13
237847stannous fluoride 0.4 % (fluoride ion 0.16 % ) Oral GelSY13

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0126-0165-93Gel-Kam Fruit and Berry122 g in 1 TUBEGEL, DENTIFRICE12213
0126-0165-93Gel-Kam Fruit and Berry1 in 1 CARTONGEL, DENTIFRICE113
0126-0192-93Gel-Kam Mint122 g in 1 TUBEGEL, DENTIFRICE12213
0126-0192-93Gel-Kam Mint1 in 1 CARTONGEL, DENTIFRICE113

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0126-0165GEL-KAM MINT (STANNOUS FLUORIDE) GEL, DENTIFRICE GEL-KAM FRUIT AND BERRY (STANNOUS FLUORIDE) GEL, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.]13Current NDC, Legacy NDC, 2 package rows20240119_8c2c3c5c-ddef-4a4d-8bc3-5a98c577e74c.zip
0126-0192GEL-KAM MINT (STANNOUS FLUORIDE) GEL, DENTIFRICE GEL-KAM FRUIT AND BERRY (STANNOUS FLUORIDE) GEL, DENTIFRICE [COLGATE ORAL PHARMACEUTICALS, INC.]13Current NDC, Legacy NDC, 2 package rows20240119_8c2c3c5c-ddef-4a4d-8bc3-5a98c577e74c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0126-0192-93GM - Gram0126-01922f391b90-6296-499e-97e3-27ef5272ce9512015-10-02
0126-0165-93GM - Gram0126-0165e4d91c1c-ce35-4abb-b0c2-8f5631a0526212015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Stannous FluorideACTIVE INGREDIENT3FTR44B32Q1
FLUORIDE IONACTIVE MOIETYQ80VPU408O1
GlycerinINACTIVE INGREDIENTPDC6A3C0OX1
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)INACTIVE INGREDIENTS38J6RZN161

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0126-01920126-0192-93
0126-01650126-0165-93

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Source Document#

Source XML

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 2 · 72 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16POWDER, FOR SUSPENSION / ORAL560 mgExact identifier — unii candidate
60 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SUSPENSION / ORAL100 mgExact identifier — unii candidate
60 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16TABLET, EXTENDED RELEASE / ORAL350 mgExact identifier — unii candidate
60 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16POWDER, FOR SUSPENSION / ORAL560 mgExact identifier — unii candidate
60 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16TABLET, EXTENDED RELEASE / ORAL350 mgExact identifier — unii candidate
60 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SUSPENSION / OPHTHALMIC0.25 %w/vExact identifier — unii candidate
60 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
60 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SPRAY / NASAL0.1 mg/0.2mlExact identifier — unii candidate
60 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SUSPENSION / ORAL100 mgExact identifier — unii candidate
60 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii+route
12 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii+route
12 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii+route
12 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SOLUTION / ORAL3 mgExact identifier — unii candidate
60 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii+route
12 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16TABLET, CHEWABLE / ORAL5.9 mgExact identifier — unii candidate
60 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16POWDER, FOR SUSPENSION / ORAL560 mgExact identifier — unii candidate
60 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16TABLET, CHEWABLE / ORAL5.9 mgExact identifier — unii candidate
60 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SUSPENSION / AURICULAR (OTIC)1 mgExact identifier — unii candidate
60 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16GEL / TOPICAL4 mgExact identifier — unii candidate
60 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SOLUTION / TOPICAL0.21 %w/vExact identifier — unii candidate
60 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SYRUP / ORAL2 mg/5mlExact identifier — unii candidate
60 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SOLUTION / TOPICAL0.21 %w/vExact identifier — unii candidate
60 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SOLUTION / ORAL3 mgExact identifier — unii candidate
60 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii+route
12 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SUSPENSION / OPHTHALMIC0.25 %w/vExact identifier — unii candidate
60 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SOLUTION/ DROPS / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
60 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SOLUTION / TOPICAL0.21 %w/vExact identifier — unii candidate
60 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16LOTION / TOPICAL0.2 %w/vExact identifier — unii candidate
60 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
60 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16LOTION / TOPICAL0.2 %w/vExact identifier — unii candidate
60 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SOLUTION/ DROPS / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
60 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SUSPENSION / ORAL100 mgExact identifier — unii candidate
60 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SUSPENSION / AURICULAR (OTIC)1 mgExact identifier — unii candidate
60 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
60 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16TABLET, CHEWABLE / ORAL5.9 mgExact identifier — unii candidate
60 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16TABLET, EXTENDED RELEASE / ORAL350 mgExact identifier — unii candidate
60 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16LOTION / TOPICAL0.2 %w/vExact identifier — unii candidate
60 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii+route
12 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii+route
12 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16LOTION / TOPICAL0.2 %w/vExact identifier — unii candidate
60 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SYRUP / ORAL2 mg/5mlExact identifier — unii candidate
60 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SYRUP / ORAL2 mg/5mlExact identifier — unii candidate
60 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii+route
12 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SOLUTION / TOPICAL0.21 %w/vExact identifier — unii candidate
60 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii+route
12 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SUSPENSION / TOPICAL0.69 %w/vExact identifier — unii candidate
60 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SPRAY / NASAL0.1 mg/0.2mlExact identifier — unii candidate
60 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SUSPENSION / AURICULAR (OTIC)1 mgExact identifier — unii candidate
60 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SUSPENSION / AURICULAR (OTIC)1 mgExact identifier — unii candidate
60 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16TABLET, EXTENDED RELEASE / ORAL350 mgExact identifier — unii candidate
60 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SUSPENSION / TOPICAL0.69 %w/vExact identifier — unii candidate
60 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SUSPENSION / ORAL100 mgExact identifier — unii candidate
60 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SUSPENSION / OPHTHALMIC0.25 %w/vExact identifier — unii candidate
60 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16POWDER, FOR SUSPENSION / ORAL560 mgExact identifier — unii candidate
60 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii+route
12 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16GEL / TOPICAL4 mgExact identifier — unii candidate
60 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SOLUTION / ORAL3 mgExact identifier — unii candidate
60 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16SOLUTION/ DROPS / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
60 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16GEL / TOPICAL4 mgExact identifier — unii candidate
60 equally ranked IID candidates
Hydroxyethyl Cellulose (2000 MPA.S AT 1%)HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)S38J6RZN16GEL / TOPICAL4 mgExact identifier — unii candidate
60 equally ranked IID candidates

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
Gel-Kam Fruit and BerrySTANNOUS FLUORIDEColgate Oral Pharmaceuticals, Inc.8c2c3c5c-ddef-4a4d-8bc3-5a98c577e74c2024-01-18WarningsExact identifier
ndc (package): 0126-0165-93
ndc (package): 0126-0192-93
ndc (product): 0126-0165
ndc (product): 0126-0192
ndc11 (package): 00126019293
ndc11 (package): 00126016593
spl id: d11d1acf-71a3-433a-8845-31d9a40bdfbd
spl set id: 8c2c3c5c-ddef-4a4d-8bc3-5a98c577e74c

Reported adverse events (FAERS/openFDA)#

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