FDA.reportPublic FDA data

NDC 70710-1641-01 - Lubiprostone

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
70710-1641
Requested NDC
70710-1641-01
Package NDCs from labels
70710-1641-6, 70710-1641-1, 70710-1641-01
Manufacturer
Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM
Effective date
2025-02-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Lubiprostone - Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEMAsclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM2025-02-06HUMAN PRESCRIPTION DRUG LABEL
Lubiprostone - Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences LimitedZydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited2023-03-27HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-1641-1Lubiprostone100 in 1 BOTTLECAPSULE1001
70710-1641-6Lubiprostone60 in 1 BOTTLECAPSULE601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1641LUBIPROSTONE CAPSULE [ZYDUS PHARMACEUTICALS USA INC.]1Current NDC, 2 package rows20230328_6c11a204-6831-4269-a3c4-1702ed83f74b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1641-6EA - Each70710-164179a1fbe8-ccab-408f-a0af-228071c2b41512023-12-05

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 117 of 118 · 2,344 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cover Recover SPF 30 IvoryZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Incfe207b88-8eb8-424d-89b4-8d5b188dd2c32017-12-05WarningsExact identifier
unii: 15FIX9V2JP
Cover Recover SPF 30 TawnyZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Inc94d604d4-b0bf-4f3e-888c-b6104241925b2017-12-05WarningsExact identifier
unii: 15FIX9V2JP
Cover Recover SPF 30 CocoaZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Inc9f6a5740-174c-4244-b291-6ab6367ce5122017-12-05WarningsExact identifier
unii: 15FIX9V2JP
SkinPerfect Primer SPF 30TITANIUM DIOXIDE AND ZINC OXIDEDermalogica, Inc.5fc75cef-5b76-44ab-891a-7b90c04a06812017-12-05WarningsExact identifier
unii: 15FIX9V2JP
Cover Recover SPF 30 TaupeZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Inc46e1dc9c-acb8-4a61-8503-065d18c9eb302017-12-05WarningsExact identifier
unii: 15FIX9V2JP
Cover Recover SPF 30 CreamZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Inc5096ab46-879c-49ec-b0f0-18462814adec2017-12-05WarningsExact identifier
unii: 15FIX9V2JP
Cover Recover SPF 30 Warm BeigeZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Incd8cab2e9-02fd-451c-b0e0-70ba0fc274d52017-12-05WarningsExact identifier
unii: 15FIX9V2JP
Cover Recover SPF 30 SandZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Ince5e8d83e-b3e6-470f-b521-4d7e96ecd1b62017-12-05WarningsExact identifier
unii: 15FIX9V2JP
Cover Recover SPF 30 BeigeZINC OXIDE AND TITANIUM DIOXIDEAllure Labs, Incec6749b7-377b-4ac5-8992-ac709bd0204e2017-12-05WarningsExact identifier
unii: 15FIX9V2JP
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
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
Age Renewal Firming and Hydrating Moisturizer SPF 30OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDECVS Health5f6f677d-2404-4e56-a48f-4263314afd9b2017-03-14WarningsExact identifier
unii: 15FIX9V2JP
Your Name Cosmetics Brightening CC Cream Broad Spectrum SPF 20YOUR NAME COSMETICS BRIGHTENING CC CREAM BROAD SPECTRUM SPF 20Mana Productsae6a86d2-a95b-4fa8-9676-233ef9fdc3b02017-02-22WarningsExact identifier
unii: 15FIX9V2JP
Nuance Salma Hayek Renewed Radiance Brightening BB Cream Broad Spectrum SPF 30 SunscreenNUANCE SALMA HAYEK RENEWED RADIANCE BRIGHTENING BB CREAM BROAD SPECTRUM SPF 30 SUNSCREENCVS Pharmacy, Inc7795e651-838e-41f8-b48d-bd2e0dd1beec2017-01-18WarningsExact identifier
unii: 15FIX9V2JP
DERMAdoctor DD Cream Dermatologically Defining BB Cream Broad Spectrum SPF 30DERMADOCTOR DD CREAM DERMATOLOGICALLY DEFINING BB CREAM BROAD SPECTRUM SPF 30Mana Productscec89a7e-1670-4d3c-b48c-28ed1ea7f9572016-12-07WarningsExact identifier
unii: 15FIX9V2JP
Age Renewal FirmingOCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDEAMCOL Health & Beauty Solutions, Inc. DBA6cb27f87-40a3-4049-aded-eb788509c5752016-10-07WarningsExact identifier
unii: 15FIX9V2JP
Nuance Salma Hayek Renewed Radiance Brightening BB Cream Broad Spectrum SPF 30 SunscreenNUANCE SALMA HAYEK RENEWED RADIANCE BRIGHTENING BB CREAM BROAD SPECTRUM SPF 30 SUNSCREENMana Productsd0e00d97-dbf4-46af-aeda-bdfd6f49b5ab2016-09-08WarningsExact identifier
unii: 15FIX9V2JP
Meijer Kids Tear Free SPF 50TITANIUM DIOXIDE, ZINC OXIDEMeijer Distribution, Inc.7415511e-1ecf-4646-b64b-267fbf7d116b2016-06-02WarningsExact identifier
unii: 15FIX9V2JP
Meijer Baby Tear Free SPF 50TITANIUM DIOXIDE, ZINC OXIDEMeijer Distributing Inc.2434de23-bcc9-4a83-9945-16fc3f2b8c612016-06-01WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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