FDA.reportPublic FDA data

NDC 62559-138-11 - Hydrocortisone

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
62559-138
Requested NDC
62559-138-11
Package NDCs from labels
62559-138-11, 62559-138-07
Manufacturer
ANI Pharmaceuticals, Inc.
Effective date
2026-03-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hydrocortisone - ANI Pharmaceuticals, Inc.ANI Pharmaceuticals, Inc.2026-03-02HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62559-138-07Hydrocortisone7 in 1 BOXENEMA75
62559-138-11Hydrocortisone60 mL in 1 BOTTLEENEMA605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-138HYDROCORTISONE ENEMA [ANI PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 2 package rows20181122_40654d12-56e4-4489-be49-19c60ad918ad.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-138-07ML - Milliliter62559-1385a2fa582-5cc7-4222-aa81-1eba7548138412013-02-13
62559-138-11ML - Milliliter62559-138d119c80f-b591-4b98-bc9d-cba313f4fe3a12016-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HydrocortisoneACTIVE INGREDIENTWI4X0X7BPJHYDROCORTISONE ENEMA [ANIP ACQUISITION COMPANY]2
HydrocortisoneACTIVE MOIETYWI4X0X7BPJHYDROCORTISONE ENEMA [ANIP ACQUISITION COMPANY]2
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENTZ135WT9208HYDROCORTISONE ENEMA [ANIP ACQUISITION COMPANY]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THYDROCORTISONE ENEMA [ANIP ACQUISITION COMPANY]2
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HHYDROCORTISONE ENEMA [ANIP ACQUISITION COMPANY]2
Sodium hydroxideINACTIVE INGREDIENT55X04QC32IHYDROCORTISONE ENEMA [ANIP ACQUISITION COMPANY]2
WaterINACTIVE INGREDIENT059QF0KO0RHYDROCORTISONE ENEMA [ANIP ACQUISITION COMPANY]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 1 of 34 · 678 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SurviveX Anti-itch CreamSURVIVEX HYDROCORTISONENantong Health & Beyond Hygienic Products Inc.5a7a1141-d3b1-0ee8-e063-6294a90a16aa2026-09-04WarningsExact identifier
unii: WI4X0X7BPJ
CVS Cortisone LiquidHYDROCORTISONECVS Pharmacy42df45a9-d449-090a-e063-6394a90a9ee42026-09-01WarningsExact identifier
unii: WI4X0X7BPJ
Terramed Just Think Comfort Hydrocortisone 1% CreamHYDROCORTISONERida LLC0d2c0c2c-370f-4adb-b0ea-1e218c927f8b2026-09-01WarningsExact identifier
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONEAmerican Health Packaging506aab0d-9308-4d60-90b3-7d64952fff362026-08-31Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Good Neighbor Pharmacy Hydrocortisone With Aloe for Sensitive SkinHYDROCORTISONEAmerisourceBergenc5c5b5ca-b4d4-4fa8-b647-b3ccb29664952026-08-30WarningsExact identifier
unii: WI4X0X7BPJ
Gembooxt RINGWORM CreamMICONAZOLE NITRATE, HYDROCORTISONEGuangdong Quadrant Ecological Technology Co., Ltd.464a33c3-6d16-0cfd-e063-6294a90abf4b2026-08-27WarningsExact identifier
unii: WI4X0X7BPJ
Gembooxt ECZEMA RELIEF CreamHYDROCORTISONEGuangdong Quadrant Ecological Technology Co., Ltd.46490d65-f789-eaa2-e063-6294a90a623b2026-08-27WarningsExact identifier
unii: WI4X0X7BPJ
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
HydrocortisoneHYDROCORTISONEAmazon.com Services LLC5f87d7fb-f258-48b0-8b60-1055e22ebd712026-08-25WarningsExact identifier
unii: WI4X0X7BPJ
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
PROCTOZONE-HCHYDROCORTISONE 2.5%Preferred Pharmaceuticals, Inc.5f055f94-b213-431b-897e-1c439660f1582026-08-21Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Rohto Max StrengthNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companye4b49550-1ca3-4bd7-854d-409b53fa5e262026-08-20WarningsExact identifier
unii: 6OZP39ZG8H
ANTI ITCHHYDROCORTISONEHyVee Inc1ab6bbb8-2b91-4c53-9168-b1e85ac296e92026-08-19WarningsExact identifier
unii: WI4X0X7BPJ
hydrocortisone 1HYDROCORTISONEKroger Companyf05edff2-2dc5-427c-b52c-518e0aaef4e02026-08-19WarningsExact identifier
unii: WI4X0X7BPJ
Hydrocortisone with AloeHYDROCORTISONE CREAM 1/2%Sun Pharmaceutical Industries, Inc.59337940-c9be-58af-e063-6394a90abe132026-08-16WarningsExact identifier
unii: WI4X0X7BPJ
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
JJ CareHYDROCORTISONENantong Health & Beyond Hygienic Products Inc.c88fa151-f8a8-4de2-98c9-71319bf53e362026-08-13WarningsExact identifier
unii: WI4X0X7BPJ
HydrocortisoneHYDROCORTISONESafetec of America, Inc.da2b3b2c-11e0-401b-bbd2-d019271d1b3d2026-08-13WarningsExact identifier
unii: WI4X0X7BPJ
HydralynHYDRALYNOncora Pharma, LLC835f0335-0215-4955-9099-b601604916952026-08-12Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
HYDROCORTISONEHYDROCORTISONEAmazon.com Services LLCf40b4223-e81f-4cd0-bc9b-d3d33ce8cce52026-08-12WarningsExact identifier
unii: WI4X0X7BPJ

Reported adverse events (FAERS/openFDA)#

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