FDA.reportPublic FDA data

NDC 68210-0200-01 - IBUPROFEN

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
68210-0200
Requested NDC
68210-0200-01
Package NDCs from labels
68210-0200-1, 68210-0200-01
Manufacturer
SPIRIT PHARMACEUTICALS,LLC
Effective date
2024-12-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
IBUPROFEN - SPIRIT PHARMACEUTICALS,LLCSPIRIT PHARMACEUTICALS,LLC2024-12-30HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68210-0200-1IBUPROFEN10 in 1 BOTTLECAPSULE, LIQUID FILLED108
68210-0200-1IBUPROFEN1 in 1 CARTONCAPSULE, LIQUID FILLED18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-0200IBUPROFEN CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS,LLC]8Current NDC, Legacy NDC, 2 package rows20250101_2810122e-3c89-49a2-8dac-db3714cb7b45.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 73 of 74 · 1,461 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IBUPROFEN, DIPHENHYDRAMINE HCLIBUPROFEN, DIPHENHYDRAMINE HCLBionpharma Inc.59a97c31-db90-48e1-ac1b-0f7026c8ec942018-11-09WarningsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENContract Pharmacal Corp.237bcb87-64a0-415b-bd53-e9d3b8bf33b62018-11-07WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLPremier Value Alliance LLC21afce91-afbe-4b38-a8a5-8775148835e82018-10-30WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENGeritrex LLCca9498ec-755d-4a09-9504-210dd48d6fed2018-10-12WarningsExact identifier
unii: WK2XYI10QM
Childrens IbuprofenIBUPROFENGuardian Drug Company694866ce-c419-4b4c-bfb2-4175703d89f12018-09-07WarningsExact identifier
unii: WK2XYI10QM
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
IBUPROFENIBUPROFEN 200MGADVANCED FIRST AID, INC.564e9910-b491-4129-a4f1-68216267623b2018-07-23WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen ChildrensIBUPROFENH E B0a9a54ce-572f-4a96-922f-cc136d2d4aad2018-06-07WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBreeden Brothers, LLCe4314153-479d-4c0f-ba49-4d4efded304b2018-04-06WarningsExact identifier
unii: WK2XYI10QM
First Aid Only Ammonia InhalantsAMMONIA INHALANTSAcme United Corporation6595a2a5-f2d7-85cf-e053-2991aa0a9b522018-02-19WarningsExact identifier
unii: 5138Q19F1X
Ibuprofen Fast relief medicine for painIBUPROFEN 200 MGAllegiant Healthdd63b011-0573-4374-9669-8d29146e5fc92017-11-17WarningsExact identifier
unii: WK2XYI10QM
Sound Body IbuprofenIBUPROFEN 200 MGAllegiant Health73af6385-3081-49cc-83de-f872a47c31dc2017-11-15WarningsExact identifier
application number: ANDA079205
rxcui: 310964
unii: WK2XYI10QM
Ibuprofen 200mgIBUPROFEN 200MGAthlete's Needs, Inc.2db10105-6fd3-420d-8889-7cfd6f396e5f2017-11-14WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPuraCap Pharmaceutical LLCacc4cbc8-085d-42f3-ad93-113e0b55631c2017-11-09WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCVS PHARMACY, INC.cdd5a402-df90-4a16-a38c-78eab71899982017-11-09WarningsExact identifier
unii: WK2XYI10QM
Homeoplex DGLYCERINUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (SUIS), LITHIUM CARBONICUM, THYROIDINUM (SUIS), SALICYLICUM ACIDUM, ADRENOCORTICOTROPHIN, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM,Supplement Clinic, LLC.cd6b48ab-3566-484d-8deb-15ef6f8e7e8f2017-11-01WarningsExact identifier
unii: 506T60A25R
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Fast Pain ReliefIBUPROFENHealthLife of USA LLCa3fcd34a-6aa9-477c-bbfb-2f6b36e06b652017-06-05WarningsExact identifier
unii: WK2XYI10QM
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
Dye Free IbuprofenIBUPROFENBreeden Brothers, LLCba106f6f-2c6b-4c98-a10e-d27622b08b252017-02-15WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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