FDA.reportPublic FDA data

NDC 85509-1010-06 - Ibuprofen and famotidine

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
85509-1010
Requested NDC
85509-1010-06
Package NDCs from labels
85509-1010-9, 85509-1010-6, 85509-1010-3, 85509-1010-06
Manufacturer
PHOENIX RX LLC
Effective date
2025-07-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ibuprofen and famotidine - PHOENIX RX LLCPHOENIX RX LLC2025-07-11HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85509-1010-3Ibuprofen and famotidine30 in 1 BOTTLETABLET, FILM COATED303
85509-1010-6Ibuprofen and famotidine60 in 1 BOTTLETABLET, FILM COATED603
85509-1010-9Ibuprofen and famotidine90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85509-1010-3EA - Each85509-101091ca5b65-8ef7-4662-8f14-bc1194501e3f12025-09-12
85509-1010-6EA - Each85509-1010c9ff290c-e9a5-4f07-9836-75855ea1f3e012025-09-12
85509-1010-9EA - Each85509-1010c5107af1-483a-4566-8903-7eb27d6af39112025-09-12

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 8 of 214 · 4,264 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DUAL ACTION COMPLETEFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEAmazon.com Services LLC4e8a936c-b876-4923-ad9e-d23537b5d7cf2026-07-28WarningsExact identifier
unii: 5QZO15J2Z8
IbuprofenIBUPROFENH E B21567c0f-abba-4a40-a0b9-5ce49b3d96482026-07-28WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.656658cc-8cf0-42b6-af4f-4e3ab76486252026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
FamotidineFAMOTIDINEAscend Laboratories, LLCb2228be0-472b-4e47-9910-af0bf12fde772026-07-27Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
Pepcid CompleteFAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDEKenvue Brands LLCa2ef8424-7d80-42b0-a01e-f378f629b2b62026-07-24WarningsExact identifier
unii: 5QZO15J2Z8
IbuprofenIBUPROFENREMEDYREPACK INC.a7756b22-73cf-4262-aa8e-0577ddecd03b2026-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENShield Pharmaceuticals Corp1ca722bb-940e-4b3e-9561-d87e2feb1ff82026-07-24WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENShield Pharmaceuticals Corpfc6c29b4-f1b3-4cfe-8c96-564d083be39c2026-07-24WarningsExact identifier
unii: WK2XYI10QM
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-COCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S.A.575fb2c3-e332-8a3b-e063-6394a90a9fd92026-07-24WarningsExact identifier
unii: 15FIX9V2JP
NeutraflushEYEWASH STATION ADDITIVE CONCENTRATEAero Healthcare1d9ff2ef-9c9b-f367-e063-6294a90afa0e2026-07-24WarningsExact identifier
unii: 6DC9Q167V3
childrens ibuprofenIBUPROFENRite Aid Corporation26bccfc1-bc8d-4241-a078-c760048951c92026-07-24WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENHF Acquisition Co LLC, DBA HealthFirst574b6f15-70bc-fca7-e063-6294a90a04552026-07-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENSafeway, Inc.a530d43d-e9c4-4edb-af66-c92860e46f452026-07-23WarningsExact identifier
unii: WK2XYI10QM
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
unii: 15FIX9V2JP
IbuprofenIBUPROFENTWIN MED LLCf03958f8-aeae-edf0-e053-2a95a90a3e9e2026-07-22WarningsExact identifier
unii: WK2XYI10QM
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
unii: 532B59J990
COMPLETE ACID REDUCERFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED962ced24-0fb3-4aba-b32e-2e6fa1c1c5d72026-07-22WarningsExact identifier
unii: 5QZO15J2Z8
Good Sense ibuprofenIBUPROFENL. Perrigo Companyaebae4b3-18c8-4ecf-b578-1fe7cc50076b2026-07-22WarningsExact identifier
unii: WK2XYI10QM
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE571f23e9-1126-e32d-e063-6294a90a99512026-07-21WarningsExact identifier
unii: 15FIX9V2JP
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.d3a7ebef-f7ab-4b34-b62e-278a8deabf782026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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