FDA.reportPublic FDA data

NDC 70518-3554-01 - Fluoxetine

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
70518-3554
Requested NDC
70518-3554-01
Package NDCs from labels
70518-3554-0, 70518-3554-1, 70518-3554-2, 70518-3554-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-10-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fluoxetine - REMEDYREPACK INC.REMEDYREPACK INC.2026-10-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3554-0Fluoxetine30 in 1 BLISTER PACKCAPSULE308
70518-3554-1Fluoxetine90 in 1 BOTTLE, PLASTICCAPSULE908
70518-3554-2Fluoxetine30 in 1 BOTTLE, PLASTICCAPSULE308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3554FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [REMEDYREPACK INC.]5Current NDC, Legacy NDC, 3 package rows20250507_d121146e-7439-4169-a421-dab7b882b8aa.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 115 of 142 · 2,837 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sheet SPF 30 MineralTITANIUM DIOXIDE, ZINC OXIDEVivier Pharma Inc.bbb5b87c-d641-3ba2-e053-2a95a90a0f702024-02-14WarningsExact identifier
unii: 15FIX9V2JP
sheer tint SPF 45BROAD SPECTRUMCP Skin Health Group, Inc.b7c5cedd-ff68-74de-e053-2a95a90a37962024-02-14WarningsExact identifier
unii: 15FIX9V2JP
FluoxetineFLUOXETINE HYDROCHLORIDENorthStar Rx LLC97960730-432e-4e94-bb4e-62a3157270a82024-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313989
rxcui: 310384
rxcui: 310385
unii: I9W7N6B1KJ
REPAIRWEAR LASER FOCUS SPF 15 LINE SMOOTHING CO/OOCTINOXATE, TITANIUM DIOXIDECLINIQUE LABORATORIES LLC10f7ec01-541b-a15a-e063-6294a90aa9df2024-02-09WarningsExact identifier
unii: 15FIX9V2JP
Perfect SleepADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, UBIDECARENONUM, L-TRYPTOPHAN, MELATONIN, PYRROLE, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUS (BACH)Deseret Biologicals, Inc.6d934960-63c6-4536-bde3-38c26f8083dc2024-02-06WarningsExact identifier
unii: ETJ7Z6XBU4
FluoxetineFLUOXETINE HYDROCHLORIDETIME CAP LABORATORIES, INC.d7a4db7f-cdac-2b36-e053-2995a90a8d642024-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 313989
rxcui: 310384
rxcui: 310385
unii: I9W7N6B1KJ
COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Golden HourTITANIUM DIOXIDECOOLA, LLCedfda0f5-0f72-5cc7-e053-2a95a90ae38d2024-02-02WarningsExact identifier
unii: 15FIX9V2JP
COOLA Mineral Liplux Lip Balm SPF 30 Summer CrushZINC OXIDECOOLA, LLCedc6754e-dabb-5bff-e053-2a95a90a73902024-02-02WarningsExact identifier
unii: 15FIX9V2JP
COOLA Mineral Liplux Lip Balm SPF 30 Skinny DipZINC OXIDECOOLA, LLCee01f936-81a9-a54d-e053-2a95a90a52272024-02-02WarningsExact identifier
unii: 15FIX9V2JP
toty Solaria MineralTITANIUM DIOXIDE, ZINC OXIDEChipican LLCe9d590d8-e71a-0715-e053-2a95a90a5acf2024-02-01WarningsExact identifier
unii: 15FIX9V2JP
SiliceaSILICON DIOXIDESEVENE USA0805d866-ce1a-4f54-8a44-83d4902e8c0d2024-01-30WarningsExact identifier
unii: ETJ7Z6XBU4
ATOMY DERMA CALMING SUNTITANIUM DIOXIDEATOMY CO., LTD.fd5fc3ba-6e7c-4e48-8e65-47c03141df452024-01-30WarningsExact identifier
unii: 15FIX9V2JP
FluoxetineFLUOXETINEAurobindo Pharma Limited5336ce59-7a6c-4db9-8512-299cc5e599c02024-01-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEAurobindo Pharma Limited3daecd20-6a59-44d3-8269-4912214c08b42024-01-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
FluoxetineFLUOXETINEAurobindo Pharma Limited3195db14-0cae-4b49-9fba-49b869fe92a82024-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: I9W7N6B1KJ
Sleep TightADENOSINUM TRIPHOSPHORICUM DINATRUM, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, UBIDECARENONUM, L-TRYPTOPHAN, MELATONIN, PYRROLE, ARSENICUM ALBUM, AVENA SATIVA, CHAMOMILLA, COFFEA CRUDA, MERCURIUS CORROSIVUS, PASSIFLORA INCARNATA, SILICEA, ZINCUM VALERIANICUM, DYSENTERY BACILLUS, GAERTNER BACILLUS (BACH)Dr. Donna Restivo DCb5955fbc-71f8-4fe0-9df0-42f337ab9c7d2024-01-18WarningsExact identifier
unii: ETJ7Z6XBU4
Shunly Radiant Translucent SPF 40TITANIUM DIOXIDE, ZINC OXIDEShunly Skin Care LLC20783833-ee7f-4425-b4ab-ab61cda5b2c82024-01-17WarningsExact identifier
unii: 15FIX9V2JP
Shunly Radiant Translucent Tinted SPF 40TITANIUM DIOXIDE, ZINC OXIDEShunly Skin Care LLC1aeb5e05-730c-4c5c-b164-ad9347b0cd932024-01-17WarningsExact identifier
unii: 15FIX9V2JP
Cerave Developed with Dermatologists Hydrating Sunscreen SPF 50 Body Lightweight, non-greasy feel 3 essential ceramides Mineral SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc4a243c9f-ca88-47fb-8777-1da79c001c732024-01-16WarningsExact identifier
unii: 15FIX9V2JP
MY MEDIC SPF 30 REEF FRIENDLY SUNSCREENHOMOSALATE, TITANIUM DIOXIDE, ETHYLHEXYL SALICYLATE, PHENYLBENZIMIDAZOLE SULFONIC ACIDSled Distribution, LLCec252876-7205-83ec-e053-2a95a90a14632024-01-15WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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