FDA.reportPublic FDA data

NDC 70518-4348-00 - Fluticasone Propionate and Salmeterol DISKUS

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
70518-4348
Requested NDC
70518-4348-00
Package NDCs from labels
70518-4348-0, 70518-4348-00
Manufacturer
REMEDYREPACK INC.
Effective date
2026-09-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fluticasone Propionate and Salmeterol DISKUS - REMEDYREPACK INC.REMEDYREPACK INC.2026-09-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4348-0Fluticasone Propionate and SalmeterolDISKUS1 in 1 CARTONPOWDER11
70518-4348-0Fluticasone Propionate and SalmeterolDISKUS60 in 1 INHALERPOWDER601

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 7 of 9 · 178 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fluticasone PropionateFLUTICASONE PROPIONATEProficient Rx LPab8c172b-c369-4372-95f9-dd1a28b3982b2024-10-01Warnings, Adverse reactionsExact identifier
unii: O2GMZ0LF5W
Dairy Allergen MixADENOSINUM TRIPHOSPHORICUM DINATRUM, BENZOICUM ACIDUM, CHOLINUM, CINNAMIC ACID, EUGENOL, FOLIC ACID, FORMALINUM, HISTAMINUM HYDROCHLORICUM, L-ASPARAGINE (MONOHYDRATE), LAC DEFLORATUM, LAC VACCINUM, MENADIONE, OOPHORINUM (SUIS), PETROSELINUM SATIVUM, PHENYL ISOTHIOCYANATE, QUERCETIN, RUTIN, SACCHARUM LACTIS, ILEUM (SUIS), JEJUNUM (SUIS), STOMACH (SUIS), COUMARINUM, FOLLICULINUM, GABA (GAMMA-AMINOBUTYRIC ACID), SARCOLACTICUM ACIDUM, LAC CANINUM, LAC FELINUM, LAC HUMANUM, PIPERINE, CALCAREA CARBONICA,Deseret Biologicals, Inc.e03d8463-287a-4509-a9f4-0ad38a98377c2024-09-11WarningsExact identifier
unii: J2B2A4N98G
Dairy Allergen MixADENOSINUM TRIPHOSPHORICUM DINATRUM, BENZOICUM ACIDUM, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCIUM CITRATE, CALCIUM GLUCONATE, CARBO VEGETABILIS, CHAMOMILLA, CHOLINUM, CINNAMIC ACID, COUMARINUM, EUGENOL, FOLIC ACID, FOLLICULINUM, FORMALINUM, GABA (GAMMA-AMINOBUTYRIC ACID), GAERTNER BACILLUS (BACH), HISTAMINUM HYDROCHLORICUM, ILEUM (SUIS), JEJUNUM (SUIS), L-ASPARAGINE (MONOHYDRATE), LAC CANINUM, LAC DEFLORATUM, LAC FELINUM, LAC HUMANUM, LAC VACCINUM, MENADIONE,Deseret Biologicals, Inc.e2bc26d2-1719-40c5-a6f9-8ff1f364c3cf2024-09-06WarningsExact identifier
unii: J2B2A4N98G
FluticasoneFLUTICASONE PROPIONATENuCare Pharmaceuticals,Inc.549ff4f2-fa68-3dd8-e054-00144ff8d46c2024-07-15Warnings, Adverse reactionsExact identifier
unii: O2GMZ0LF5W
Fluticasone PropionateFLUTICASONE PROPIONATENuCare Pharmaceuticals,Inc.8761a5e1-a9cb-0622-e053-2a95a90a35042024-06-14Warnings, Adverse reactionsExact identifier
unii: O2GMZ0LF5W
CHILDRENS ALLERGYFLUTICASONE PROPIONATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDb9b3efe4-2f5c-4d22-80a4-d15fb266fb232024-06-12WarningsExact identifier
unii: O2GMZ0LF5W
Fluticasone Propionate and Salmeterol HFAFLUTICASONE PROPIONATE AND SALMETEROL XINAFOATEPrasco Laboratories666c5b12-a4f7-4c53-8261-4742b5e5a6df2024-05-29Warnings, Adverse reactionsExact identifier
unii: 6EW8Q962A5
unii: O2GMZ0LF5W
ADVAIR HFAFLUTICASONE PROPIONATE AND SALMETEROL XINAFOATEGlaxoSmithKline LLCdfaca6f9-3277-47b2-319d-1377917cb54c2024-05-23Warnings, Adverse reactionsExact identifier
unii: 6EW8Q962A5
unii: O2GMZ0LF5W
AllergiesAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUMNewton Laboratories, Inc.9d5dea47-5103-21a3-e053-2995a90aee782024-05-20WarningsExact identifier
unii: J2B2A4N98G
fluticasone propionateFLUTICASONE PROPIONATEPadagis Israel Pharmaceuticals Ltdc4d361d4-d480-4fb2-8cc7-4cc3e57838dc2024-05-01Warnings, Adverse reactionsExact identifier
unii: O2GMZ0LF5W
Fluticasone PropionateFLUTICASONE PROPIONATEAllegiant Health4250d331-17b0-46be-a779-fb4f09bade162024-04-11WarningsExact identifier
unii: O2GMZ0LF5W
Fluticasone PropionateFLUTICASONE PROPIONATEBryant Ranch Prepack96e0681d-3788-49cc-8c0e-3185675b8da12024-04-04Warnings, Adverse reactionsExact identifier
unii: O2GMZ0LF5W
Fluticasone Propionate and SalmeterolFLUTICASONE PROPIONATE AND SALMETEROLBryant Ranch Prepack84654ac7-e2b4-4fa1-b127-69aee03aecc02024-04-04Warnings, Adverse reactionsExact identifier
unii: 6EW8Q962A5
unii: O2GMZ0LF5W
Fluticasone PropionateFLUTICASONE PROPIONATEBryant Ranch Prepackaed4ac53-cf6e-489e-bb7e-b8c444e4339e2024-04-04Warnings, Adverse reactionsExact identifier
unii: O2GMZ0LF5W
Fluticasone PropionateFLUTICASONE PROPIONATEBryant Ranch Prepackf6aca9a9-0310-4c11-84b2-eacd19c45a1d2024-04-04Warnings, Adverse reactionsExact identifier
unii: O2GMZ0LF5W
Fluticasone PropionateFLUTICASONE PROPIONATEBryant Ranch Prepack8204a0c2-bd24-409a-b848-b3b369df642f2024-03-11Warnings, Adverse reactionsExact identifier
unii: O2GMZ0LF5W
AllergiesAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUMNewton Laboratories, Inc.9d4c4d88-43da-49dd-e053-2995a90af18d2024-03-07WarningsExact identifier
unii: J2B2A4N98G
CHILDRENS FLONASE ALLERGY RELIEFFLUTICASONE PROPIONATEHaleon US Holdings LLCfab7a1f4-75e0-416f-9644-07aff08e6ab02024-03-05WarningsExact identifier
unii: O2GMZ0LF5W
CHILDRENS FLONASE ALLERGY RELIEFFLUTICASONE PROPIONATEHaleon US Holdings LLC3adff80f-fca7-4cc5-b106-0f68f71c85b02024-02-08WarningsExact identifier
unii: O2GMZ0LF5W
ADVAIR DISKUSFLUTICASONE PROPIONATE AND SALMETEROLA-S Medication Solutions7c9c722b-68ac-4bda-ad99-50e3fb1c58c82024-01-30Warnings, Adverse reactionsExact identifier
application number: NDA021077
rxcui: 896184
unii: 6EW8Q962A5
unii: O2GMZ0LF5W

Reported adverse events (FAERS/openFDA)#

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