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 38 of 243 · 4,860 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLCardinal Health5c5d6c13-9b51-48f0-8627-b60b0f707fd32026-03-12WarningsExact identifier
unii: FZ989GH94E
CHILDRENS IBUPROFENIBUPROFENAdvagen Pharma Ltd.4b8b06f3-8557-4645-af27-c0819e163b792026-03-12WarningsExact identifier
unii: WK2XYI10QM
Pepcid CompleteFAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDEKenvue Brands LLCe874118f-b4fe-4c80-aece-99ea20e7e8052026-03-12WarningsExact identifier
unii: H0G9379FGK
ADVILIBUPROFENHaleon US Holdings LLC1a665e64-9f30-be37-4a83-38789f1f1e892026-03-12WarningsExact identifier
unii: WK2XYI10QM
Alka-Seltzer Heartburn Plus Gas ReliefChews Tropical PunchCALCIUM CARBONATE AND SIMETHICONEBayer HealthCare LLC.41d17406-3653-4889-81df-6270b7b5d3c72026-03-12WarningsExact identifier
unii: H0G9379FGK
AMAZON Ultra Strength Tropical FruitANTACID TABLETS (CALCIUM CARBONATE)AMAZON.COM SERVICES LLCdd93a70e-8b43-495e-bda3-526e5d6de9532026-03-12WarningsExact identifier
unii: H0G9379FGK
complete dual actionFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEHyVee Inc237efe92-b302-4e11-93fe-7b0f727a00aa2026-03-12WarningsExact identifier
unii: H0G9379FGK
IbuprofenIBUPROFENWalgreen Company86818ad6-fd45-4635-9ce8-eac986f008aa2026-03-11WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENDiscount Drug Martd0ebf2a7-551b-4acd-be60-2d0b936dd7032026-03-11WarningsExact identifier
unii: WK2XYI10QM
Neutrogena Healthy Skin Liquid Makeup Broad Spectrum SPF 20 - Cool Bronze 440CTITANIUM DIOXIDEKenvue Brands LLC4c335d9c-40ca-c0ce-e063-6394a90ac20a2026-03-11WarningsExact identifier
unii: 15FIX9V2JP
Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLHEB3fb6c1e5-f877-2cd0-e063-6294a90ae6542026-03-11WarningsExact identifier
unii: WK2XYI10QM
BASIC CARE IBUPROFENIBUPROFENAmazon.com Services LLCae50a548-dc32-4c5b-b133-c6537267127b2026-03-11WarningsExact identifier
unii: WK2XYI10QM
Lower GI and Probiotic RestorationAETHUSA CYNAPIUM, ALLIUM SATIVUM, BAPTISIA TINCTORIA, CAPSICUM ANNUUM, CARBO VEGETABILIS, CHAMOMILLA, CINCHONA OFFICINALIS, COLLINSONIA CANADENSIS, COLOCYNTHIS, CONDURANGO, GAMBOGIA, GRATIOLA OFFICINALIS, LAC VACCINUM, LACTICUM ACIDUM, NATRUM CARBONICUM, NUX VOMICA, PODOPHYLLUM PELTATUM, SEPIA AND SILICEA.King Bio Inc.2e1f3ca1-9036-4f14-bd3c-d0eed9a9ff932026-03-10WarningsExact identifier
unii: ETJ7Z6XBU4
Acetaminophen 250 mg and Ibuprofen 125 mgACETAMINOPHEN 250 MG AND IBUPROFEN 125 MG TABLETSSun Pharmaceutical Industries, Inc.2a31a975-72f9-2a16-e063-6394a90a81492026-03-10WarningsExact identifier
unii: WK2XYI10QM
Constitutional EnhancerACONITUM NAPELLUS, ARSENICUM ALBUM, BARYTA CARBONICA, BRYONIA, CALCAREA CARBONICA, CANTHARIS, GELSEMIUM SEMPERVIRENS, GRAPHITES, HYDRASTIS CANADENSIS, KALI IODATUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, RHUS TOX, SEPIA, SILICEA AND SULPHUR.King Bio Inc.448becd7-58aa-40ae-9b4b-39f48a8f13dd2026-03-10WarningsExact identifier
unii: ETJ7Z6XBU4
Sinus Pressure and Congestion Relief Maximum StrengthPSEUDOEPHEDRINE HCLRite Aid Corporationd86140ab-1117-4d14-a380-f5cc375775a12026-03-10WarningsExact identifier
unii: 6V9V2RYJ8N
VermiclearGRANATUM, RHAMNUS PURSHIANA, JUGLANS REGIA, FILIX MAS, ABSINTHIUM, AESCULUS HIPPOCASTANUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, CINA, CINCHONA OFFICINALIS, CUPRUM METALLICUM, IPECACUANHA, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, NUX VOMICA, PODOPHYLLUM PELTATUM, PULSATILLA (VULGARIS), RATANHIA, RHUS TOX, SABADILLA, SILICEA, SPIGELIA ANTHELMIA, TEREBINTHINA, TEUCRIUM MARUMEnergique, Inc.f7cf3edd-2451-4a4f-b1f2-1b3db2bb4dca2026-03-09WarningsExact identifier
unii: ETJ7Z6XBU4
IbuprofenIBUPROFENBryant Ranch Prepack0550fa2f-f25e-4abb-b10e-a3d05bdb32172026-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBryant Ranch Prepackc38a03fa-6b9a-4737-a848-063ca5c580b92026-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
RYNEX PSEBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDEEDWARDS PHARMACEUTICALS, INC.2f2d9b5a-f66b-4928-8d43-402ef9efcfdf2026-03-05WarningsExact identifier
unii: 6V9V2RYJ8N

Reported adverse events (FAERS/openFDA)#

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