FDA.reportPublic FDA data

NDC 85509-1315-09 - 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
85509-1315
Requested NDC
85509-1315-09
Package NDCs from labels
85509-1315-9, 85509-1315-3, 85509-1315-6, 85509-1315-09
Manufacturer
PHOENIX RX LLC
Effective date
2025-10-15
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 LLC2025-10-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85509-1315-3IBUPROFEN AND FAMOTIDINE30 in 1 BOTTLETABLET301
85509-1315-6IBUPROFEN AND FAMOTIDINE60 in 1 BOTTLETABLET601
85509-1315-9IBUPROFEN AND FAMOTIDINE90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85509-1315-3EA - Each85509-1315528a400e-c262-4e87-a4e6-f50be04c575512025-12-16
85509-1315-6EA - Each85509-1315e0501a27-bfc0-48b2-96d1-60f64457b75312025-12-16
85509-1315-9EA - Each85509-1315975714dd-75b6-449e-98d9-0fa06518ab8212025-12-16

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 1 of 125 · 2,484 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
dual actionACETAMINOPHEN, IBUPROFENRite Aid Corporation54b08d24-d5e9-4111-9d97-329896e8309d2026-09-09WarningsExact identifier
unii: WK2XYI10QM
Leader Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDECardinal Healthaee4bbe2-4f11-4c54-be8b-df48b3ba4f3a2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
IbuprofenIBUPROFENLidl US LLC0ca02f8b-4413-4e7c-a67b-8c67c53e13432026-09-09WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENGOODSENSE596a1007-08ea-00ec-e063-6394a90a5eb22026-09-09WarningsExact identifier
unii: WK2XYI10QM
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
FamotidineFAMOTIDINEREMEDYREPACK INC.669fbd46-cae5-4477-884e-8eca893d2e052026-09-09Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
ibuprofen childrensIBUPROFENRite Aid Corporationc6e68886-edcb-414d-9cba-0d97772ef8b62026-09-09WarningsExact identifier
unii: WK2XYI10QM
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
COMPLETE ACID REDUCERFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDb023cd92-eabb-474b-9b5a-4b46cf48256b2026-09-08WarningsExact identifier
unii: 5QZO15J2Z8
Ibuprofen minisIBUPROFENThe Kroger Co.15709fa7-114b-453c-b63d-f1c4f28f0f952026-09-08WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENREMEDYREPACK INC.2144eff0-d7ab-486d-b116-a4ff3ae2afe22026-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Clear Eyes NighttimeGLYCERINPrestige Brands Holdings, Inc.af75e2f7-81dd-43e0-a390-b52bbfbebf622026-09-08WarningsExact identifier
unii: PDC6A3C0OX
IbuprofenIBUPROFENThe Kroger Co.a7789f7f-3356-463b-9fd7-2d7f7eba27992026-09-08WarningsExact identifier
unii: WK2XYI10QM
FamotidineFAMOTIDINEAurohealth LLC5b161f25-c578-4ff4-a931-ff3a1e681c502026-09-04WarningsExact identifier
unii: 5QZO15J2Z8
IBUPROFENIBUPROFENAmazon.com Services LLC90659e83-d989-46a5-9680-3a4f616125112026-09-04WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENDirect_Rx40071818-5bf0-095b-e063-6294a90ad58a2026-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMCVS Pharmacy3167c918-a7d3-46a1-a85b-64f9c22916f22026-09-04WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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