FDA.reportPublic FDA data

NDC 21091-269-01 - 0.1% Ketoconazole, 0.15% Salicylic Acid

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
21091-269
Requested NDC
21091-269-01
Package NDCs from labels
21091-269-01
Manufacturer
Sergeant's Pet Care Products LLC | SV Labs Prescott Corporation | Sharon Bio-Medicine Limited | Sigma-Aldrich Manufacturing LLC
Effective date
2024-04-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PetArmor Ear Rinse for dogs and catsSergeant's Pet Care Products LLC | SV Labs Prescott Corporation | Sharon Bio-Medicine Limited | Sigma-Aldrich Manufacturing LLC2024-04-19OTC ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21091-269-010.1% Ketoconazole, 0.15% Salicylic Acid1 in 1 CONTAINERSOLUTION, GEL FORMING / DROPS12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21091-2690.1% KETOCONAZOLE, 0.15% SALICYLIC ACID (EAR RINSE) SOLUTION, GEL FORMING / DROPS [SERGEANT'S PET CARE PRODUCTS LLC]21 package rows20240420_52fdfba8-1a6b-4b59-90de-14c5160cf6fe.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 89 of 102 · 2,040 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clear Acne Face MoisturizerACNE FACE MOISTURIZERKamedisb9304cde-1778-40c7-889f-f7647820f44f2024-02-07WarningsExact identifier
unii: O414PZ4LPZ
CLEAR IMPROVEMENT ACNE CLEARING HYDRATING LTNSALICYLIC ACIDORIGINS NATURAL RESOURCES INC.10a4bae1-bbbb-0bf3-e063-6294a90a4af62024-02-05WarningsExact identifier
unii: O414PZ4LPZ
CLEAR IMPROVEMENT BLACKHEAD CLEARING MASK TO SCRUBSALICYLIC ACIDORIGINS NATURAL RESOURCES INC.10a54180-5ad9-d4af-e063-6394a90a26f92024-02-05WarningsExact identifier
unii: O414PZ4LPZ
Sterile WaterSTERILE WATERChartwell RX, LLC3681eeaa-807a-47ca-9fbc-61c2b682800a2024-02-01Exact identifier
unii: 059QF0KO0R
Ear RingingACONITUM NAP., BARYTA CARB., BARYTA MUR., CAPSICUM, CAUSTICUM, CHENOPODIUM ANTHELMINTICUM, CHININUM SULPHURICUM, CINCHONA, GLONOINUM, GRAPHITES, HYDRASTIS, KALI BIC., KALI MUR., LYCOPODIUM, PHOSPHORUS, PULSATILLA, SALICYLICUM AC., TABACUM, THIOSINAMINUM, VIOLA ODORATANewton Laboratories, Inc.1043debe-8787-a2f5-e063-6294a90a2a662024-01-31WarningsExact identifier
unii: O414PZ4LPZ
Ear RingingACONITUM NAP., BARYTA CARB., BARYTA MUR., CAPSICUM, CAUSTICUM, CHENOPODIUM ANTHELMINTICUM, CHININUM SULPHURICUM, CINCHONA, GLONOINUM, GRAPHITES, HYDRASTIS, KALI BIC., KALI MUR., LYCOPODIUM, PHOSPHORUS, PULSATILLA, SALICYLICUM AC., TABACUM, THIOSINAMINUM, VIOLA ODORATANewton Laboratories, Inc.1045ab27-c4d5-fcbd-e063-6294a90a51762024-01-31WarningsExact identifier
unii: O414PZ4LPZ
TinnitusACONITUM NAP., BARYTA CARB., BARYTA MUR., CAPSICUM, CAUSTICUM, CHENOPODIUM ANTHELMINTICUM, CHININUM SULPHURICUM, CINCHONA, GLONOINUM, GRAPHITES, HYDRASTIS, KALI BIC., KALI MUR., LYCOPODIUM, PHOSPHORUS, PULSATILLA, SALICYLICUM AC., TABACUM, THIOSINAMINUM, VIOLA ODORATANewton Laboratories, Inc.10462aaa-96d4-4ba3-e063-6294a90a79152024-01-31WarningsExact identifier
unii: O414PZ4LPZ
Sterile WaterWATERA-S Medication Solutionsdba87371-31d2-47c2-ab83-89aabce4b1842024-01-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
No More ProductsGLYCERIN, KAOLIN, CALAMINE, MENTHOLSarati International, Inc102e7dbb-06dc-f4d1-e063-6394a90aa3eb2024-01-26WarningsExact identifier
unii: PDC6A3C0OX
Pranicura 5GLYCERIN, KAOLIN, CALAMINE, MENTHOLSarati International, Inc.0fe10710-ac59-4fc5-e063-6294a90a48fc2024-01-26WarningsExact identifier
unii: PDC6A3C0OX
GENTEAL TEARSDEXTRAN 70, GLYCERIN, HYPROMELLOSEA-S Medication Solutionsa2b715e9-332d-4f0b-b8e5-ebc0006815862024-01-21WarningsExact identifier
unii: PDC6A3C0OX
Hydro GelGLYCERIN 20%Trifecta Pharmaceuticals USA LLC02e8e5d0-7844-39fe-e063-6394a90a57e12024-01-19WarningsExact identifier
unii: PDC6A3C0OX
Samsali Wart RemoverWART REMOVERShenzhen Xinxin Yunhai Technology Co., Ltd.0f32eb6d-0174-59aa-e063-6394a90a70872024-01-18WarningsExact identifier
unii: O414PZ4LPZ
Ulensy Corn Callus and Wart RemoverCORN CALLUS AND WART REMOVERShenzhen Xinxin Yunhai Technology Co., Ltd.0f3353ef-e105-7bd4-e063-6394a90a25622024-01-18WarningsExact identifier
unii: O414PZ4LPZ
KetoconazoleKETOCONAZOLEBryant Ranch Prepack02a348b0-1325-4298-8813-83970da32c7a2024-01-11Warnings, Adverse reactionsExact identifier
unii: R9400W927I
Salicylic AcidSALICYLIC ACIDAcella Pharmaceuticals, LLC996ad0d5-d635-4ed4-8263-d7f7732604212024-01-11Warnings, Adverse reactionsExact identifier
unii: O414PZ4LPZ
KetoconazoleKETOCONAZOLEBryant Ranch Prepackdc635682-170d-46ad-a9ba-6a75c6e0950e2024-01-11Warnings, Adverse reactionsExact identifier
unii: R9400W927I
Prosoria ScalpSALICYLIC ACIDNuvothera, Inc.52a98715-3e57-4b86-b91e-0ce433dc22bd2024-01-10WarningsExact identifier
unii: O414PZ4LPZ
Prosoria Psoriasis TreatmentSALICYLIC ACIDNuvothera, Inc.f94f4481-c58e-4555-9863-cbaa2c4cdd072024-01-10WarningsExact identifier
unii: O414PZ4LPZ
B05 GLUCO BALANCEADRENALINUM, ARGENTUM NITRICUM, BOS TAURUS PITUITARUM POSTERIUM, GLYCERINUM, GLYCYRRHIZA GLABRA, KALI CARBONICUM, LACTICUM ACIDUM, MAGNESIA SULPHURICA, NICCOLUM METALLICUM, PANCREATINUM, PHOSPHORICUM ACIDUM, SACCHARINUM, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, SELENIUM METALLICUM, SYZYGIUM JAMBOLANUM, THYROIDINUM, ZINCUM METALLICUMApex Energetics Inc.bae9ff7e-eb69-c61d-e053-2995a90a26272024-01-08WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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