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 142 of 238 · 4,744 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENCare One (Retail Business Services, LLC.)a6ce7484-7a32-4985-80bc-883c31be35252025-03-12WarningsExact identifier
unii: WK2XYI10QM
Se-Natal 19 ChewableVITAMINS AND MINERALSSeton Pharmaceuticalsa54dd642-8884-415a-a082-cd9fb544e4002025-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: H0G9379FGK
AddiclenzASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, BETA VULGARIS, BISPHENOL A, BOLDO, CHELIDONIUM MAJUS, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PETROSELINUM SATIVUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, TARAXACUM OFFICINALE, ZINCUM METALLICUMDeseret Biologicals, Inc.25036c26-1c21-4e5a-b4db-b8e1774583412025-03-11WarningsExact identifier
unii: OJ245FE5EU
unii: 15FIX9V2JP
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.8afc0167-17bf-4ccd-91c9-8fb9c4e241c12025-03-11WarningsExact identifier
unii: 6V9V2RYJ8N
Sudafed PE Head Congestion Plus PainIBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC76513fb2-7323-4f1f-8a10-92f8f603cf972025-03-10WarningsExact identifier
unii: WK2XYI10QM
HISTEX-DM New FormulationDEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCI, AND TRIPROLIDINE HCIAllegis Pharmaceuticals, LLC30010401-e5b4-2bd9-e063-6394a90a0b0b2025-03-10WarningsExact identifier
unii: 6V9V2RYJ8N
Ultra Strength Antacid Assorted FruitCALCIUM CARBONATEDeMoulas Market Basketa7257be7-bef3-4fe7-8789-cc3da45168752025-03-05WarningsExact identifier
unii: H0G9379FGK
Extra Strength Antacid Tropical FruitCALCIUM CARBONATEDeMoulas Market Basket28bb40b6-8803-413e-846f-dedc3c0532762025-03-04WarningsExact identifier
unii: H0G9379FGK
Redicare Antacid Mint FlavoredREDICARE ANTACID MINT FLAVOREDRedicare LLC2f259f79-d321-5566-e063-6294a90a15222025-03-04WarningsExact identifier
unii: H0G9379FGK
Redicare Ibuprofen 200mgIBUPROFEN 200MGRedicare LLC2f0db953-33e2-1729-e063-6294a90af0742025-03-04Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
MINERAL TINTED SPF 30TITANIUM DIOXIDE, ZINC OXIDEBOTANICAL SCIENCE, INC.2f9e2252-fb54-363f-e063-6294a90aa7c92025-03-04WarningsExact identifier
unii: 15FIX9V2JP
Extra Strength Assorted Berry AntacidCALCIUM CARBONATEDeMoulas Market Basket726c5e9f-55e6-416a-b001-0b56b05d7d1d2025-03-04WarningsExact identifier
unii: H0G9379FGK
Extra Strength Antacid Assorted FruitCALCIUM CARBONATEDeMoulas Market Basket9b07ad97-3f0f-401b-a855-6474b3dbdb692025-03-04WarningsExact identifier
unii: H0G9379FGK
LEADER CHILDRENS IBUPROFENIBUPROFENCardinal Health 110, LLC. dba Leader913a4bd0-0784-45b4-b05e-3e7c016bbb862025-03-03WarningsExact identifier
unii: WK2XYI10QM
CoTZ Kids Mineral Sun StickTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD2f7225d0-ddfa-e19a-e063-6294a90a52a82025-03-03WarningsExact identifier
unii: 15FIX9V2JP
equate ibuprofenIBUPROFENWal-Mart Stores Inc2daee8c1-d05e-406b-af65-b81bbbaa244d2025-03-03WarningsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENPadagis Israel Pharmaceuticals Ltd02889717-204c-463b-8506-4c5cf18c77d32025-03-03WarningsExact identifier
unii: WK2XYI10QM
Sun Defense Minerals (Fair)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e21c9f9-acf8-997b-e063-6394a90ada3f2025-03-01WarningsExact identifier
unii: 15FIX9V2JP
Sun Defense Minerals (Medium)ZINC OXIDE, TITANIUM DIOXIDEEminence Organic Skin Care2e232e8d-4274-68bc-e063-6394a90a942b2025-03-01WarningsExact identifier
unii: 15FIX9V2JP
Extra Strength Smooth Antacid Assorted FruitsCALCIUM CARBONATEGood Sense (Geiss, Destin & Dunn, Inc.)2595385c-60ad-44e5-b3e3-1b9ac53044032025-02-28WarningsExact identifier
unii: H0G9379FGK

Reported adverse events (FAERS/openFDA)#

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