FDA.reportPublic FDA data

NDC 51672-4074-01 - Hydrocortisone Butyrate

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
51672-4074
Requested NDC
51672-4074-01
Package NDCs from labels
51672-4074-5, 51672-4074-7, 51672-4074-1, 51672-4074-2, 51672-4074-6, 51672-4074-01
Manufacturer
Sun Pharmaceutical Industries, Inc. | Taro Pharmaceutical Industries Ltd.
Effective date
2026-07-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hydrocortisone Butyrate Ointment, 0.1% Hydrocortisone Butyrate Cream USP, 0.1% Hydrocortisone Butyrate Topical Solution, 0.1%Sun Pharmaceutical Industries, Inc. | Taro Pharmaceutical Industries Ltd.2026-07-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-4074-1Hydrocortisone Butyrate1 in 1 CARTONCREAM15
51672-4074-1Hydrocortisone Butyrate15 g in 1 TUBECREAM155
51672-4074-2Hydrocortisone Butyrate30 g in 1 TUBECREAM305
51672-4074-2Hydrocortisone Butyrate1 in 1 CARTONCREAM15
51672-4074-5Hydrocortisone Butyrate5 g in 1 TUBECREAM55
51672-4074-6Hydrocortisone Butyrate45 g in 1 TUBECREAM455
51672-4074-6Hydrocortisone Butyrate1 in 1 CARTONCREAM15
51672-4074-7Hydrocortisone Butyrate1 in 1 CARTONCREAM15
51672-4074-7Hydrocortisone Butyrate10 g in 1 TUBECREAM105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4074HYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]5Current NDC, Legacy NDC, 9 package rows20210409_51176835-598d-4da7-8a00-6bd36f52aa82.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4074-1GM - Gram51672-4074e175c1af-8333-4d53-bdc8-9d48bb0de46f12012-07-24
51672-4074-6GM - Gram51672-40744eeceb59-6e4f-4111-8f59-ee88a7b420e912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Hydrocortisone ButyrateACTIVE INGREDIENT05RMF7YPWNHYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
HydrocortisoneACTIVE MOIETYWI4X0X7BPJHYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLHYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
anhydrous trisodium citrateINACTIVE INGREDIENTRS7A450LGAHYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
butylparabenINACTIVE INGREDIENT3QPI1U3FV8HYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
ceteth-20INACTIVE INGREDIENTI835H2IHHXHYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1SHYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPHYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
glycerinINACTIVE INGREDIENTPDC6A3C0OXHYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
high density polyethyleneINACTIVE INGREDIENTUG00KM4WR7HYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
isopropyl alcoholINACTIVE INGREDIENTND2M416302HYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
light mineral oilINACTIVE INGREDIENTN6K5787QVPHYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
mineral oilINACTIVE INGREDIENTT5L8T28FGPHYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
petrolatumINACTIVE INGREDIENT4T6H12BN9UHYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
povidonesINACTIVE INGREDIENTFZ989GH94EHYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHHYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
trisodium citrate dihydrateINACTIVE INGREDIENTB22547B95KHYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3
waterINACTIVE INGREDIENT059QF0KO0RHYDROCORTISONE BUTYRATE SOLUTION HYDROCORTISONE BUTYRATE CREAM HYDROCORTISONE BUTYRATE OINTMENT [TARO PHARMACEUTICALS U.S.A., INC.]3

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 59 of 93 · 1,855 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VaselineBABY HEALING JELLYConopco Inc. d/b/a Unileverbca3176f-86fe-5969-e053-2995a90a24192025-03-31WarningsExact identifier
unii: 4T6H12BN9U
SaniiswabISOPROPYL ALCOHOLPOLLEY MED LLC303b1ad5-a104-3479-e063-6294a90abcde2025-03-20WarningsExact identifier
unii: ND2M416302
Dr. Butler Hemorrhoid and PerinealMINERAL OIL 59.8%,PETROLATUM 36%Beyond Health P.A.d17b6f16-6893-ce0a-e053-2a95a90aa23a2025-03-19WarningsExact identifier
unii: T5L8T28FGP
Mineral OilMINERAL OILKesin Pharma Corporation30a11cc9-e407-23b7-e063-6294a90a7d6e2025-03-18WarningsExact identifier
unii: T5L8T28FGP
Leader Nighttime Relief Lubricant EyeLIGHT MINERAL OIL, WHITE PETROLATUMLEADER/Cardinal Health 110, Inc.308772fc-d6f6-da9f-e063-6394a90a41db2025-03-12WarningsExact identifier
unii: N6K5787QVP
Alka-Seltzer Heartburn Relief Extra StrengthANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED)Bayer Healthcare LLCdc1641f8-54c2-0d86-e053-2995a90a1dce2025-03-11WarningsExact identifier
unii: 2968PHW8QP
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: Z8IX2SC1OH
Bestmade Natural Products Field of Flowers FormulaAESCULUS CAR, AESCULUS HIP, AGRIMONIA EUP, BROMUS RAM, CALLUNA VULG, CARPINUS BET, CASTANEA SAT, CENTAURIUM UMB, CERATOSTIGMA WILLM, CICHORIUM INT, CLEMATIS VIT, FAGUS SYLV, GENTIANELLA AMARELLA, HELIANTHEMUM NUMMULARIUM, ILEX AQUIFOLIUM, IMPATIENS GLAND, LARIX DECIDUA, LONICERA CAPRIFOLIUM, MALUS, MIMULUS GUT, OLEA EUROP, ORNITHOGALUM UMB, PINUS SYL, POPULUS TREM, PRUNUS CERA, QUERCUS ROB, ROCK WATER, ROSA CAN, SALIX VIT, SCLERANTHUS ANNNUS, SINAPIS ARV, ULEX EURO, ULMUS PROC, VERBENA, VITIS VINBestmade Natural Products2fbf9b7c-e54f-589d-e063-6394a90a14a72025-03-07WarningsExact identifier
unii: 059QF0KO0R
Winco Medicated Lip BalmPETROLATUMWincoc81cd9f7-f23a-4873-8542-1926497d39ce2025-03-07WarningsExact identifier
unii: 4T6H12BN9U
AD Skin ProtectantAD SKIN PROTECTANTWellSpring Pharmaceutical Corporationd26f1312-2e1b-4106-bc48-a336d4e034ad2025-03-07WarningsExact identifier
unii: 4T6H12BN9U
Curist Hemorrhoid Fissure ReliefLIDOCAINELittle Pharma, Inc2fb02b00-acdb-5184-e063-6294a90ae1c82025-03-06WarningsExact identifier
unii: 4T6H12BN9U
unii: PDC6A3C0OX
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLUniversal Distribution Center LLC2f982aef-4f46-aa85-e063-6394a90a52b12025-03-05WarningsExact identifier
unii: ND2M416302
ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREENISOPROPYL ALCOHOLUniversal Distribution Center LLC2f9846ce-37ca-a95b-e063-6294a90ad2602025-03-05WarningsExact identifier
unii: ND2M416302
Isopropyl Rubbing Alcohol 70%ISOPROPYL ALCOHOLUniversal Distribution Center LLC2f988951-39e7-ec02-e063-6294a90aaad72025-03-05WarningsExact identifier
unii: ND2M416302
Isopropyl alcoholISOPROPYL ALCOHOLUniversal Distribution Center LLC2f98a900-6c7c-0161-e063-6294a90ac6752025-03-05WarningsExact identifier
unii: ND2M416302
Equate SPF 15 Lip BalmAVOBENZONE, OCTINOXATE, PETROLATUMWalmarte41e15cf-3284-426e-9e81-d60c39fb29962025-03-05WarningsExact identifier
unii: 4T6H12BN9U
Thera Plus HemorrhoidalGLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDEFOURSTAR GROUP USA, INC.87143a7a-7b2d-4b67-afda-2355697e73002025-03-04WarningsExact identifier
unii: 4T6H12BN9U
unii: PDC6A3C0OX
Clear Eyes Maximum Redness ReliefNAPHAZOLINE HYDROCHLORIDE AND GLYCERINPrestige Brands Holdings, Inc.c3b0e344-68dd-4c35-bf46-744e612a5b152025-02-28WarningsExact identifier
unii: PDC6A3C0OX
Isopropyl alcoholISOPROPYL ALCOHOLAmerisourceBergen (Good Neighbor Pharmacy) 46122c47986e9-c851-491b-817e-fd3e0b054cd42025-02-26WarningsExact identifier
unii: ND2M416302
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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