FDA.reportPublic FDA data

GRAFCO

Product NDC
12165-100
Requested package NDC
12165-100-01
11-digit product format
121650100
Labeler code
12165
Product ID
12165-100_2649734d-3624-4cf6-9fa7-b0cec914c214
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Silver Nitrate
Dosage form
STICK
Route
TOPICAL
Labeler
GF Health Products, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
1949-04-19
Substance
SILVER NITRATE; POTASSIUM NITRATE
Active strength
38.21; 12.74 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
GRAFCO
Brand name suffix
APPLICATOR 15 CM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILVER NITRATE38.21 mg/1
POTASSIUM NITRATE12.74 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
95IT3W8JZEInternal UNII lookup
RU45X2JN0ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1117536Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
41a82a8c-9a4a-4610-a115-8d8c72a25b1eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12165-100-01GRAFCOAPPLICATOR 15 CM100 in 1 TUBESTICK1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
12165-100-01EA - Each12165-1004dfd0c3e-fde0-4008-9609-4b6d6d5aeb3212019-04-11
12165-100-03EA - Each12165-100d56d8ef5-c62c-4095-8b03-90bb229b78f112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Potassium NitrateACTIVE INGREDIENTRU45X2JN0ZGRAFCO APPLICATOR 15 CM (SILVER NITRATE) STICK GRAFCO APPLICATOR 30 CM (SILVER NITRATE) STICK GRAFCO APPLICATOR 45 CM (SILVER NITRATE) STICK [GF HEALTH PRODUCTS, INC.]7
Silver NitrateACTIVE INGREDIENT95IT3W8JZEGRAFCO APPLICATOR 15 CM (SILVER NITRATE) STICK GRAFCO APPLICATOR 30 CM (SILVER NITRATE) STICK GRAFCO APPLICATOR 45 CM (SILVER NITRATE) STICK [GF HEALTH PRODUCTS, INC.]7
Potassium CationACTIVE MOIETY295O53K152GRAFCO APPLICATOR 15 CM (SILVER NITRATE) STICK GRAFCO APPLICATOR 30 CM (SILVER NITRATE) STICK GRAFCO APPLICATOR 45 CM (SILVER NITRATE) STICK [GF HEALTH PRODUCTS, INC.]7
Silver CationACTIVE MOIETY57N7B0K90AGRAFCO APPLICATOR 15 CM (SILVER NITRATE) STICK GRAFCO APPLICATOR 30 CM (SILVER NITRATE) STICK GRAFCO APPLICATOR 45 CM (SILVER NITRATE) STICK [GF HEALTH PRODUCTS, INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12165-100GRAFCO APPLICATOR 15 CM (SILVER NITRATE) STICK [GF HEALTH PRODUCTS, INC.]6Current NDC, Legacy NDC, 1 package rows20210121_41a82a8c-9a4a-4610-a115-8d8c72a25b1e.zip

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
GRAFCO APPLICATOR 15 CMSILVER NITRATEGF Health Products, Inc.41a82a8c-9a4a-4610-a115-8d8c72a25b1e2021-01-19WarningsExact identifier
ndc (package): 12165-100-01
ndc (product): 12165-100
ndc11 (package): 12165010001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1117536potassium nitrate 25 % / silver nitrate 75 % Medicated PadPSN41a82a8c-9a4a-4610-a115-8d8c72a25b1e6
1117536potassium nitrate 250 MG/ML / silver nitrate 750 MG/ML Medicated PadSCD41a82a8c-9a4a-4610-a115-8d8c72a25b1e6
1117536K+ nitrate 250 MG/ML / AgNO3 750 MG/ML Medicated PadSY41a82a8c-9a4a-4610-a115-8d8c72a25b1e6
1117536Pot nitrate 250 MG/ML / AgNO3 750 MG/ML Medicated PadSY41a82a8c-9a4a-4610-a115-8d8c72a25b1e6
1117536potassium nitrate 25 % / silver nitrate 75 % Topical SpongeSY41a82a8c-9a4a-4610-a115-8d8c72a25b1e6
1117536potassium nitrate 25 % / silver nitrate 75 % Topical StickSY41a82a8c-9a4a-4610-a115-8d8c72a25b1e6
1117536potassium nitrate 25 % / silver nitrate 75 % Topical SwabSY41a82a8c-9a4a-4610-a115-8d8c72a25b1e6
1117536potassium nitrate 25 % / silver nitrate 75 % Medicated PadPSNe5ebf7aa-fbe5-45b1-e053-2a95a90a5cbf2
1117536potassium nitrate 250 MG/ML / silver nitrate 750 MG/ML Medicated PadSCDe5ebf7aa-fbe5-45b1-e053-2a95a90a5cbf2
1117536K+ nitrate 250 MG/ML / AgNO3 750 MG/ML Medicated PadSYe5ebf7aa-fbe5-45b1-e053-2a95a90a5cbf2
1117536Pot nitrate 250 MG/ML / AgNO3 750 MG/ML Medicated PadSYe5ebf7aa-fbe5-45b1-e053-2a95a90a5cbf2
1117536potassium nitrate 25 % / silver nitrate 75 % Topical SpongeSYe5ebf7aa-fbe5-45b1-e053-2a95a90a5cbf2
1117536potassium nitrate 25 % / silver nitrate 75 % Topical StickSYe5ebf7aa-fbe5-45b1-e053-2a95a90a5cbf2
1117536potassium nitrate 25 % / silver nitrate 75 % Topical SwabSYe5ebf7aa-fbe5-45b1-e053-2a95a90a5cbf2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
12165-100-0112165010001100 STICK in 1 TUBE (12165-100-01) 100 stick1949-04-190000-00-00NoNoCurrent