FDA.reportPublic FDA data

NDC 0555-1054-60 - Claravis

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
0555-1054
Requested NDC
0555-1054-60
Package NDCs from labels
0555-1054-60, 0555-1054-86, 0555-1054-56
Manufacturer
Teva Pharmaceuticals USA, Inc.
Effective date
2026-07-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Claravis - Teva Pharmaceuticals USA, Inc.Teva Pharmaceuticals USA, Inc.2026-07-22HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0555-1054-56Claravis10 in 1 CARTONCAPSULE, LIQUID FILLED1018
0555-1054-60Claravis10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1018
0555-1054-86Claravis3 in 1 CARTONCAPSULE, LIQUID FILLED318

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0555-1054CLARAVIS (ISOTRETINOIN) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA, INC.]18Current NDC, Legacy NDC, 3 package rows20220908_a31fd109-d0fd-4ab9-ba98-a3d64333c18d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0555-1054-56EA - Each0555-1054a9acbe08-a1c6-41e1-bb53-9e1d9202c21312012-07-24
0555-1054-60EA - Each0555-1054f8bdf419-4836-4944-83fd-ca9a604082a812019-07-02
0555-1054-86EA - Each0555-105479b7e708-2eef-4586-820a-caa99506f76712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ISOTRETINOINACTIVE INGREDIENTEH28UP18IFCLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
ISOTRETINOINACTIVE MOIETYEH28UP18IFCLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1CLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933CLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
AMMONIAINACTIVE INGREDIENT5138Q19F1XCLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UCLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
COTTONSEED OILINACTIVE INGREDIENTH3E878020NCLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
D&C RED NO. 7INACTIVE INGREDIENTECW0LZ41X8CLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OCLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
ETHYLENE GLYCOL MONOETHYL ETHERINACTIVE INGREDIENTIDK7C2HS09CLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
GELATININACTIVE INGREDIENT2G86QN327LCLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
INDIGOTINDISULFONATE SODIUMINACTIVE INGREDIENTD3741U8K7LCLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
SHELLACINACTIVE INGREDIENT46N107B71OCLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
SOYBEAN OILINACTIVE INGREDIENT241ATL177ACLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FCLARAVIS (ISOTRETINOIN) CAPSULE [BARR LABORATORIES, INC.]8

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 1 of 114 · 2,268 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
ISOTRETINOINISOTRETINOINAurobindo Pharma Limited4e8516dc-a3c6-4d8f-aa14-2c37c6c8f6e62026-09-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197844
rxcui: 197845
rxcui: 403930
rxcui: 197843
unii: EH28UP18IF
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
IsotretinoinISOTRETINOINAmneal Pharmaceuticals LLCc2917c3d-3499-48a0-ba53-120cb979195d2026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197844
rxcui: 197845
rxcui: 403930
rxcui: 197843
unii: EH28UP18IF
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Smelling SaltsAMMONIAShenzhen Finona Information Technology Co., Ltd3874ec89-0f1d-87b9-e063-6394a90a300a2026-08-24WarningsExact identifier
unii: 5138Q19F1X
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
IsotretinoinISOTRETINOINZydus Pharmaceuticals USA Inc.31f62a49-4c6d-4ce3-a0ca-d159562370b12026-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197844
rxcui: 197845
rxcui: 403930
rxcui: 197843
unii: EH28UP18IF
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: 6DC9Q167V3
Rohto Max StrengthNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companye4b49550-1ca3-4bd7-854d-409b53fa5e262026-08-20WarningsExact identifier
unii: 6OZP39ZG8H
Smelling SaltsAMMONIA INHALANT, SMELLING SALTSHodayfa Abu Alkian524e002c-f509-9395-e063-6394a90acd9e2026-08-20WarningsExact identifier
unii: 5138Q19F1X
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
IsotretinoinISOTRETINOINActavis Pharma, Inc.1cf11710-f966-4529-8e08-02175f588bca2026-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197844
rxcui: 197845
rxcui: 403930
rxcui: 197843
unii: EH28UP18IF
Smelling SaltsAMMONIA INHALANT, SMELLING SALTSShenzhen Leadtop E-commerce Co.,Ltd.558e8629-6a8d-198d-e063-6294a90ac5fc2026-08-19WarningsExact identifier
unii: 5138Q19F1X
Absorica LDISOTRETINOINSun Pharmaceutical Industries, Inc.3ef0cff8-19c1-4441-b780-fca6c7ee16152026-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197844
rxcui: 197845
rxcui: 403930
rxcui: 197843
unii: EH28UP18IF

Reported adverse events (FAERS/openFDA)#

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