FDA.reportPublic FDA data

NDC 68898-127-08 - 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
68898-127
Requested NDC
68898-127-08
Package NDCs from labels
68898-127-04, 68898-127-08
Manufacturer
Animal Pharmaceuticals | Stratford Care Usa, Inc.
Effective date
2021-11-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hydrocortisone SPRAYAnimal Pharmaceuticals | Stratford Care Usa, Inc.2021-11-05OTC ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68898-127-04Hydrocortisone118 mL in 1 BOTTLE, SPRAYSPRAY1181
68898-127-08Hydrocortisone237 mL in 1 BOTTLE, SPRAYSPRAY2371

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68898-127HYDROCORTISONE (HYDROCORTISONE, PRAMOXINE HYDROCHLORIDE) SPRAY [ANIMAL PHARMACEUTICALS]12 package rows20211110_514ffb7d-9fef-43fa-92ed-992b8f00d91d.zip

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 201 of 204 · 4,068 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SpectricETHYLICUM, KALI BROMATUM, ASPARTIC ACID, L-DOPA, SEROTONIN (HYDROCHLORIDE), CEREBRUM SUIS, PLACENTA TOTALIS SUIS, AGARICUS MUSCARIUS, BUFO RANA, HELLEBORUS NIGER, HYOSCYAMUS NIGER, OLIBANUM (BOSWELLIA SERRATA), STRAMONIUM, THUJA OCCIDENTALIS, HELIUM, NEON, CARCINOSIN, HYDROGENDeseret Biologicals, Inc3e534017-4a9f-42a2-bdfd-1e8c73c0515a2022-11-08WarningsExact identifier
unii: 3K9958V90M
Sterile WaterWATERFresenius Kabi USA, LLCb45e9f1d-9c48-4b46-8541-d846b89540df2022-10-26Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye washPURIFIED WATERMcKessonbd089fde-24ba-4de5-e053-2995a90a39bb2022-10-18WarningsExact identifier
unii: 059QF0KO0R
HydrocortisoneHYDROCORTISONEAsclemed USA, Inc.459a9907-1261-4a75-8388-f0e2f466939c2022-10-12Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
Bach Original Flower Remedies Rock WaterWATERNelson Bach USA Limitedea242559-1618-3354-e053-2a95a90a1a952022-10-03WarningsExact identifier
unii: 059QF0KO0R
REFRESH OPTIVECARBOXYMETHYLCELLULOSE SODIUM AND GLYCERINAllergan, Inc.7f8d88af-fd3b-4138-af61-f24c59ccebd72022-09-23WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERMedical Purchasing Solutions, LLCe90b47e3-9636-b9ee-e053-2a95a90ad48c2022-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.ebd0839e-2e1d-4e0e-986c-19f1f5c763582022-09-15WarningsExact identifier
unii: PDC6A3C0OX
CIPRO HCCIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONEAsclemed USA, Inc.eafad445-2735-434b-a1c6-e1c6b201d2cf2022-09-07Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80Allergan, Inc.aaa943e4-7c38-4c5a-b7c0-5a656d8cafc02022-09-01WarningsExact identifier
unii: PDC6A3C0OX
Neomycin and Polymyxin B Sulfates and HydrocortisoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONEProficient Rx LPf5ef71ae-fca9-4a57-ae88-f2b2d195a1792022-08-01Warnings, Adverse reactionsExact identifier
unii: WI4X0X7BPJ
GlycerinumGLYCERINUMHahnemann Laboratories, INC.e34f8796-85b5-2946-e053-2995a90a251e2022-07-08Exact identifier
unii: PDC6A3C0OX
HydrocortisoneHYDROCORTISONEProficient Rx LPd50240db-f630-4008-a272-55ba5c9913042022-07-01Adverse reactionsExact identifier
unii: WI4X0X7BPJ
REFRESH Optive Mega-3CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.c5f2b3f2-2071-45bd-a010-67f848bc02332022-06-30WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Ethylicum (ETOH, aka Alcoholus)ETHYLICUM (ETOH, AKA ALCOHOLUS)Hahnemann Laboratories, INC.e1fef03a-ed76-4294-e053-2995a90aee672022-06-21Exact identifier
unii: 3K9958V90M
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
hydrocortisone acetate pramoxine HClHYDROCORTISONE ACETATE, PRAMOXINE HCLPadagis Israel Pharmaceuticals Ltd982f0862-2be8-4a65-8b61-8f3a95ab59512022-05-31Adverse reactionsExact identifier
unii: 88AYB867L5
Hydrocortisone Acetate Pramoxine HclHYDROCORTISONE ACETATE PRAMOXINE HCLPadagis Israel Pharmaceuticals Ltd87a4c494-56f9-48f6-8592-d610c507a4fc2022-05-31Adverse reactionsExact identifier
unii: 88AYB867L5
hydrocortisone acetate pramoxine hclHYDROCORTISONE ACETATE PRAMOXINE HCLPadagis Israel Pharmaceuticals Ltd9eea5875-d153-4bba-aee2-b1d1cd8b5e572022-05-31Adverse reactionsExact identifier
unii: 88AYB867L5

Reported adverse events (FAERS/openFDA)#

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