FDA.reportPublic FDA data

NDC 0555-1056-60 - 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
0555-1056
Requested NDC
0555-1056-60
Package NDCs from labels
0555-1056-60, 0555-1056-86
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
CLARAVIS™ (isotretinoin capsules USP)Physicians Total Care, Inc.2014-01-20HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0555-1056-60Claravis10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED1018
0555-1056-86Claravis3 in 1 CARTONCAPSULE, LIQUID FILLED318

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0555-1056CLARAVIS (ISOTRETINOIN) CAPSULE, LIQUID FILLED [TEVA PHARMACEUTICALS USA, INC.]18Current NDC, Legacy NDC, 2 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
0555-1056-60EA - Each0555-105633129b3f-fc43-4441-8f68-605cdd85ad5912019-07-02
0555-1056-86EA - Each0555-1056dc84ea9a-9fcd-40d7-b6f0-64dc4b2cd18512012-07-24

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
ISOTRETINOINACTIVE INGREDIENTEH28UP18IFCLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]4
ISOTRETINOINACTIVE MOIETYEH28UP18IFCLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]4
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1CLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]4
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933CLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]4
AMMONIAINACTIVE INGREDIENT5138Q19F1XCLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]4
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UCLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]4
COTTONSEED OILINACTIVE INGREDIENTH3E878020NCLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]4
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OCLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KCLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]4
GELATININACTIVE INGREDIENT2G86QN327LCLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HCLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]4
SHELLACINACTIVE INGREDIENT46N107B71OCLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]4
SOYBEAN OILINACTIVE INGREDIENT241ATL177ACLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]4
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FCLARAVIS (ISOTRETINOIN) CAPSULE [PHYSICIANS TOTAL CARE, INC.]4

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 179 · 3,571 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic MultipurposeDIMETHICONEL'Oreal USA Products Inc805cd262-2689-4818-8fed-ddefacbdde232026-09-10WarningsExact identifier
unii: 92RU3N3Y1O
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic MultipurposeDIMETHICONECosmetique Active Productiond19f482c-bec7-45aa-b22f-fe91a3dc717d2026-09-10WarningsExact identifier
unii: 92RU3N3Y1O
Pepto Gas plus BloatingSIMETHICONEThe Procter & Gamble Manufacturing Company3d80a5bb-0ed0-769a-e063-6394a90ac50c2026-09-10WarningsExact identifier
unii: 92RU3N3Y1O
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
MedlineDIMETHICONEMedline Industries, LP5afb3595-f014-153e-e063-6294a90ad34b2026-09-08WarningsExact identifier
unii: 92RU3N3Y1O
MedlineDIMETHICONEMedline Industries, LP5afb59b4-491c-45bb-e063-6294a90a0ae62026-09-08WarningsExact identifier
unii: 92RU3N3Y1O
Gas Relief Mint FlavorSIMETHICONERaritan Pharmaceuticals Inc329388cb-3ca1-4ecb-8b50-b1f9e00525592026-09-08WarningsExact identifier
unii: 92RU3N3Y1O
ISOTRETINOINISOTRETINOINAurobindo Pharma Limited4e8516dc-a3c6-4d8f-aa14-2c37c6c8f6e62026-09-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197844
rxcui: 197845
rxcui: 403930
rxcui: 197843
unii: EH28UP18IF
SimethiconeSIMETHICONESOFTGEL HEALTHCARE PRIVATE LIMITED3205339a-3914-4e25-e063-6394a90a07cd2026-09-04WarningsExact identifier
unii: 92RU3N3Y1O
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
Simethicone 125MG Gas ReliefSIMETHICONE 125 MGOne2Zee Limited Liability Company0df348bf-5a07-4f36-ae70-ca2961a9ce7e2026-09-04WarningsExact identifier
unii: 92RU3N3Y1O
anti diarrheal anti gasLOPERAMIDE HYDROCHLORIDE, SIMETHICONERite Aid Corporation8e954f86-bc15-45e2-9274-ca5d8a7c96872026-09-04WarningsExact identifier
unii: 92RU3N3Y1O
Infants Gas Relief DropsSIMETHICONEDOLGENCORP INC6b132ac0-e8eb-4199-85ad-5976558ee9c82026-09-03WarningsExact identifier
unii: 92RU3N3Y1O
DG HEALTH Liquid Antacid plus Anti GasCALCIUM CARBONATE, MAGNESIUM HYDROXIDE AND SIMETHICONEDOLGENCORP, LLC8ecb4418-e647-49b5-b418-1c63bb3e5a3c2026-09-03WarningsExact identifier
unii: 92RU3N3Y1O
Simethicone DropsSIMETHICONE DROPSEverpharm LLC5a6d2c1f-4067-969f-e063-6394a90aa83f2026-09-02WarningsExact identifier
unii: 92RU3N3Y1O
TEENY TUMMY Gas Relief DropsSIMETHICONEAkron Pharmadcdd0daf-5ef0-4cb2-872d-89ed6e9f6d602026-09-01WarningsExact identifier
unii: 92RU3N3Y1O
Aloetouch Protect Fragrance FreeDIMETHICONEMedline Industries, LP81f0071b-2bf3-455b-9e5d-8f3ca20adcdf2026-09-01WarningsExact identifier
unii: 92RU3N3Y1O
SILICONE SCARDIMETHICONEHaikou Flash Purchase Star Cross-Border Trade Co., Ltd.5a7727d1-09d1-3cb3-e063-6294a90a1bc52026-09-01WarningsExact identifier
unii: 92RU3N3Y1O

Reported adverse events (FAERS/openFDA)#

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