FDA.reportPublic FDA data

NDC 85534-0040-01 - Amoxicillin

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
85534-0040
Requested NDC
85534-0040-01
Package NDCs from labels
85534-0040-0, 85534-0040-1, 85534-0040-2, 85534-0040-3, 85534-0040-4, 85534-0040-5, 85534-0040-6, 85534-0040-7, 85534-0040-01
Manufacturer
HAWAII REPACK, INC. | ASCLEMED USA INC. DBA ENOVACHEM
Effective date
2026-07-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Amoxicillin - HAWAII REPACK, INC. | ASCLEMED USA INC. DBA ENOVACHEMHAWAII REPACK, INC. | ASCLEMED USA INC. DBA ENOVACHEM2026-07-17HUMAN PRESCRIPTION DRUG LABEL

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 70 of 119 · 2,365 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smoothing Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEDANIEL BEHROOZAN MD A MEDICAL CORPORATION327246c2-9d7a-2d34-e063-6294a90a5fb72025-04-10Exact identifier
unii: 15FIX9V2JP
Clarity Rx Physical Skin Defense SPF 50ZINC OXIDE AND TITANIUM DIOXIDETopiderm, Inc.b5111012-97b9-4908-95a0-d09595f9c4d92025-04-10WarningsExact identifier
unii: 15FIX9V2JP
Tinted Mineral Sunscreen SPF 50ZINC OXIDE AND TITANIUM DIOXIDETopiderm, Inc.13e5085f-df2b-46b2-b063-e58ce43799052025-04-09WarningsExact identifier
unii: 15FIX9V2JP
AMOXICILLINAMOXICILLINRedpharm Drug0a100e76-513c-98d3-e063-6294a90adf472025-04-09Warnings, Adverse reactionsExact identifier
rxcui: 308191
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutionse58a65d7-d813-446d-b70b-7465809a5d2c2025-04-09Warnings, Adverse reactionsExact identifier
application number: ANDA065271
rxcui: 308191
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutions641ec2a8-368a-4c5c-8c11-37366a06ce932025-04-08Warnings, Adverse reactionsExact identifier
application number: ANDA065271
rxcui: 308191
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutions9d56f34f-c025-4e97-8f5e-4d93f1ab00552025-04-08Warnings, Adverse reactionsExact identifier
application number: ANDA065271
rxcui: 308191
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMNorthStar Rx LLCdf4136c0-9efd-42c3-a487-e728e8b912752025-04-03Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINA-S Medication Solutions4b15c5b4-460c-449f-9e48-99870b3828262025-04-02Warnings, Adverse reactionsExact identifier
application number: ANDA065271
rxcui: 308191
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMNuCare Pharmaceuticals, Inc.31d00820-1c20-d52b-e063-6394a90ac3122025-04-02Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINProficient Rx LP577d8a00-c538-4089-b788-01b4b92d22f22025-04-01Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMProficient Rx LPb0d7eb3e-706a-482b-b106-9c137be55bb62025-04-01Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
AmoxicillinAMOXICILLINNuCare Pharmaceuticals,Inc.54c1d2a4-fe96-6efb-e054-00144ff88e882025-03-31Warnings, Adverse reactionsExact identifier
unii: 804826J2HU
ALEX MD PHD Sheer Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDEPHYSICIAN LABORATORIES INC8f64c4fa-92ee-4af0-ab1b-6c3673f9a6222025-03-28WarningsExact identifier
unii: 15FIX9V2JP
ALEX MD PHD Tinted Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDEPHYSICIAN LABORATORIES INC93873c34-5c72-43c8-b6c2-c65b596191d72025-03-28WarningsExact identifier
unii: 15FIX9V2JP
City Skin Age Defense Broad Spectrum SPF 50TITANIUM DIOXIDE AND ZINC OXIDEMurad, LLCf8c572a2-b4bc-49e9-95df-359f05bd69b72025-03-28WarningsExact identifier
unii: 15FIX9V2JP
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Deep FairLight Neutral Tan Rich Honey LightMedium and Neutral MediumTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCe17dc640-30e9-441b-a212-ef1508af79442025-03-25WarningsExact identifier
unii: 15FIX9V2JP
it cosmetics Your Skin But Better CC Plus Oil Free Matte Poreless Finish Full Coverage Broad Spectrum SPF 40 Sunscreen All ShadesTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCb7d184fb-4a9a-4720-9b00-bf0caa257a8c2025-03-25WarningsExact identifier
unii: 15FIX9V2JP
DOMINAS DARK SPOT TINTED SUNSCREENOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDELG H&H CO., LTD.2b6140cf-7e34-1658-e063-6394a90a32712025-03-24WarningsExact identifier
unii: 15FIX9V2JP
AmoxicillinAMOXICILLINPreferred Pharmaceuticals Inc.992d7829-34d1-4c88-8a5c-1a92d001d1942025-03-24Warnings, Adverse reactionsExact identifier
unii: 804826J2HU

Reported adverse events (FAERS/openFDA)#

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