FDA.reportPublic FDA data

NDC 62011-0070-01 - Ibuprofen and Pseudoephedrine Hydrochloride

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
62011-0070
Requested NDC
62011-0070-01
Package NDCs from labels
62011-0070-1, 62011-0070-01
Manufacturer
Strategic Sourcing Services LLC | Ohm Laboratories Inc | Ohm Laboratories Inc.
Effective date
2024-11-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ibuprofen and Pseudoephedrine HydrochlorideStrategic Sourcing Services LLC | Ohm Laboratories Inc | Ohm Laboratories Inc.2024-11-22HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62011-0070-1Ibuprofen and Pseudoephedrine Hydrochloride20 in 1 BLISTER PACKTABLET, SUGAR COATED205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62011-0070IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [STRATEGIC SOURCING SERVICES LLC]5Current NDC, Legacy NDC, 1 package rows20241123_d93ae778-e6e9-4d1d-8f46-c04d962a9393.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62011-0070-1EA - Each62011-00704b0fcd92-a6e0-4006-9bc4-f957d8ea9eac12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [HEALTH MART]2
PSEUDOEPHEDRINE HYDROCHLORIDEACTIVE INGREDIENT6V9V2RYJ8NIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [HEALTH MART]2
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [HEALTH MART]2
PSEUDOEPHEDRINEACTIVE MOIETY7CUC9DDI9FIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [HEALTH MART]2
ACACIAINACTIVE INGREDIENT5C5403N26OIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [HEALTH MART]2
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [HEALTH MART]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [HEALTH MART]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [HEALTH MART]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [HEALTH MART]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [HEALTH MART]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [HEALTH MART]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [HEALTH MART]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [HEALTH MART]2
GELATININACTIVE INGREDIENT2G86QN327LIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [HEALTH MART]2
GUAR GUMINACTIVE INGREDIENTE89I1637KEIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [HEALTH MART]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [HEALTH MART]2
KAOLININACTIVE INGREDIENT24H4NWX5COIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [HEALTH MART]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [HEALTH MART]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [HEALTH MART]2
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [HEALTH MART]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [HEALTH MART]2
SHELLACINACTIVE INGREDIENT46N107B71OIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [HEALTH MART]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [HEALTH MART]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [HEALTH MART]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [HEALTH MART]2
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [HEALTH MART]2
SUCROSEINACTIVE INGREDIENTC151H8M554IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [HEALTH MART]2
TALCINACTIVE INGREDIENT7SEV7J4R1UIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [HEALTH MART]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [HEALTH MART]2
TRISTEARININACTIVE INGREDIENTP6OCJ2551RIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [HEALTH MART]2
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, SUGAR COATED [HEALTH MART]2

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 128 of 239 · 4,762 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dg Health IbuprofenIBUPROFENDolgencorp, LLC9022e393-084e-499b-ac84-f35360d795922025-07-17WarningsExact identifier
unii: WK2XYI10QM
Dual Back Pain RelieverACETAMINOPHEN, IBUPROFENWalgreen Company9831f374-658a-47ec-8a7e-4ff8359570be2025-07-16WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENDemoulas Super Markets, Inc39802e26-1028-d2fe-e063-6394a90a24c72025-07-16WarningsExact identifier
unii: WK2XYI10QM
Aller-Chord FACETALDEHYDE, ACETICUM AC, ARG NIT, CAFFEINUM, CALC SULPH, CITRICUM AC, CORTISONE ACETICUM, ECHINACEA PURP, FOLLICULINUM, FRAGARIA, FUMARICUM AC, GALLICUM AC, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRANGEA, LAC VAC, LECITHIN, LIMULUS, LYCOPERSICUM, LYCOPODIUM, NAT BICARB, NAT MUR, NUX VOM, PARAFFINUM, PHOSPHORICUM AC, SACCHARUM OFF, SILICEA, TARTARICUM AC, TORULA CEREVISIAE.Energetix Corporationff4eb7b2-8272-4bd3-99a9-7e589b30d59a2025-07-15WarningsExact identifier
unii: C151H8M554
unii: ETJ7Z6XBU4
IbuprofenIBUPROFENAMERIFOODS TRADING COMPANYf6dc62db-f728-66fc-e053-6394a90a96b32025-07-15WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENMARC GLASSMAN, INC.7f366669-9d31-46c7-932d-02fa64b11f302025-07-15WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENMarc Glassman, Inc.9714e804-fadb-103d-e053-2a95a90ad7652025-07-15WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENAMERIFOODS TRADING COMPANYf6dc2a73-046b-6b93-e053-6294a90ab2952025-07-15WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENMARC GLASSMAN, INC.9714de6b-068b-d6b9-e053-2995a90a3b272025-07-15WarningsExact identifier
unii: WK2XYI10QM
DENTAL-CHORDACETICUM ACIDUM, AMMONIUM MURIATICUM, ARGENTUM METALLICUM, AURUM METALLICUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CARBOLICUM ACIDUM, CITRUS LIMONUM, CUPRUM METALLICUM, FERRUM METALLICUM, GLYCYRRHIZA GLABRA, LAPPA MAJOR, MEDULLA OSSIS SUIS, MERCURIUS SOLUBILIS, MYRRHA, NATRUM FLUORATUM, PALLADIUM METALLICUM, PHOSPHORICUM ACIDUM, PHYTOLACCA DECANDRA, SELENIUM METALLICUM, SILICEA, STANNUM METALLICUM, STAPHYSAGRIA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, X-RAY, ZINCUM OXYDATUMEnergetix Corporation6c9ba926-7c35-49fd-94d8-988ca0bb772c2025-07-15WarningsExact identifier
unii: ETJ7Z6XBU4
Gas-X Total Relief Maximum StrengthCALCIUM CARBONATE, SIMETHICONEHaleon US Holdings LLCedb0f11a-bdb7-484d-9257-09ff47b0fca42025-07-15WarningsExact identifier
unii: H0G9379FGK
Amarte ULTRA VEIL DailySUNSCREENAmarte USA LLC39e9ca98-d0e8-6b8f-e063-6394a90aa3662025-07-15WarningsExact identifier
unii: 15FIX9V2JP
Amarte ULTRA VEIL BB FairSUNSCREENAmarte USA LLC39e87950-4103-c2eb-e063-6394a90a05522025-07-15WarningsExact identifier
unii: 15FIX9V2JP
EndocrinpathALFALFA, BORAGO OFFICINALIS, CALCAREA CARBONICA, CEANOTHUS AMERICANUS, CITRICUM ACIDUM, FUCUS VESICULOSUS, GINKGO BILOBA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HYDROCOTYLE ASIATICA, HYPOTHALAMUS (BOVINE), KALI PHOSPHORICUM, PANCREAS SUIS, PHYTOLACCA DECANDRA, PITUITARUM POSTERIUM (BOVINE), SARSAPARILLA (SMILAX REGELII), SILICEA, SYZYGIUM JAMBOLANUM, TARAXACUM OFFICINALE, THYROIDINUM (BOVINE)Energetix Corporation70f84941-b8a1-48f4-9c05-554e554f00492025-07-11WarningsExact identifier
unii: ETJ7Z6XBU4
Motrin PMIBUPROFEN AND DIPHENHYDRAMINE CITRATEKenvue Brands LLC55403f19-58ae-450b-8a7b-0bc544088f202025-07-11WarningsExact identifier
unii: WK2XYI10QM
Childrens IbuprofenIBUPROFENKroger Company91da5b64-db7f-4954-89e8-977b31247f9c2025-07-11WarningsExact identifier
unii: WK2XYI10QM
Childrens IbuprofenIBUPROFENRite Aid Corporation70eb40b8-5862-4eb9-adc8-8a9d6bca7c7d2025-07-11WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEPHOENIX RX LLC397f1f23-10c2-569e-e063-6394a90a71642025-07-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Childrens IbuprofenIBUPROFENSafeway0fe94b11-f7c9-4e32-976f-e5f11d01bd642025-07-09WarningsExact identifier
unii: WK2XYI10QM
Nasal Decongestant Non-DrowsyPSEUDOEPHEDRINE HCLCVS Pharmacy3330b077-dab7-45c6-acbb-0f91f22712322025-07-09WarningsExact identifier
unii: 6V9V2RYJ8N

Reported adverse events (FAERS/openFDA)#

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