FDA.reportPublic FDA data

NDC 63629-8669-01 - hydrocortisone acetate pramoxine hcl

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
63629-8669
Requested NDC
63629-8669-01
Package NDCs from labels
63629-8669-1, 63629-8669-01
Manufacturer
Bryant Ranch Prepack
Effective date
2023-07-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
hydrocortisone acetate pramoxine hcl - Bryant Ranch PrepackBryant Ranch Prepack2023-07-18HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8669-1hydrocortisone acetate pramoxine hcl28.35 g in 1 TUBECREAM28.35104
63629-8669-1hydrocortisone acetate pramoxine hcl1 in 1 CARTONCREAM1104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8669HYDROCORTISONE ACETATE PRAMOXINE HCL CREAM [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 2 package rows20230719_3c5e1833-9908-4e4f-bdf2-7a28c14a585c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8669-1GM - Gram63629-8669db390f32-9ce1-40c5-8a73-c3b080121e6d12023-08-08

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 29 of 31 · 607 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrocortisone Acetate Pramoxine HclHYDROCORTISONE ACETATE PRAMOXINE HCLBryant Ranch Prepack2f036f41-93b9-4653-b24b-6fadf6fae4e42023-07-18Adverse reactionsExact identifier
unii: 88AYB867L5
unii: 3X7931PO74
Hydrocortisone Acetate Pramoxine HclHYDROCORTISONE ACETATE PRAMOXINE HCLBryant Ranch Prepackc79ca385-5fff-4d86-a8b2-098d3e0aa8fa2023-07-18Adverse reactionsExact identifier
unii: 88AYB867L5
unii: 3X7931PO74
Hydrocortisone Acetate Pramoxine HclHYDROCORTISONE ACETATE PRAMOXINE HCLBryant Ranch Prepack79fae74b-bef2-4e13-a2e9-da68747951eb2023-07-18Adverse reactionsExact identifier
unii: 88AYB867L5
unii: 3X7931PO74
hydrocortisone acetate pramoxine HClHYDROCORTISONE ACETATE, PRAMOXINE HCLBryant Ranch Prepack2c74c1c8-91c7-4468-9b1a-7217834311962023-07-18Adverse reactionsExact identifier
unii: 88AYB867L5
unii: 3X7931PO74
hydrocortisone acetate pramoxine HClHYDROCORTISONE ACETATE, PRAMOXINE HCLBryant Ranch Prepack1436a6cb-5fa1-41a6-87af-dfbaf0ab2e5b2023-07-18Adverse reactionsExact identifier
unii: 88AYB867L5
unii: 3X7931PO74
hydrocortisone acetate pramoxine hclHYDROCORTISONE ACETATE PRAMOXINE HCLBryant Ranch Prepack3c5e1833-9908-4e4f-bdf2-7a28c14a585c2023-07-18Adverse reactionsExact identifier
application number: ANDA085368
ndc (package): 63629-8669-1
ndc (product): 63629-8669
ndc11 (package): 63629866901
rxcui: 1235049
spl id: 8172f406-59b6-4b90-8ffd-f408d1799b71
spl set id: 3c5e1833-9908-4e4f-bdf2-7a28c14a585c
unii: 88AYB867L5
unii: 3X7931PO74
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHURBioActive Nutritional3382df85-3ec5-4371-830e-4ed345b8f51b2023-07-14WarningsExact identifier
unii: 6DC9Q167V3
PneumotoxTRITICUM AESTIVUM, ALFALFA, ARNICA MONTANA, ASCLEPIAS TUBEROSA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, FUCUS VESICULOSUS, HORDEUM VULGARE, IODIUM, NASTURTIUM AQUATICUM, PLANTAGO MAJOR, RAPHANUS SATIVUS, TRIFOLIUM PRATENSE, TRIGONELLA FOENUM-GRAECUM, SYMPHYTUM OFFICINALE, LUNG (SUIS), ORYZA SATIVA, SILICEA, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, NATRUM MURIATICUM, NITRICUM ACIDUM,BioActive Nutritional, Inc.f8846fb1-92e5-4f8e-b3b3-bc620df90a622023-07-12WarningsExact identifier
unii: 6DC9Q167V3
Bacteriostatic WaterWATERMedical Purchasing Solutions, LLC69485218-9343-952d-e053-2a91aa0ad4e82023-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Hydrocortisone AcetateHYDROCORTISONE ACETATEQUAGEN PHARMACEUTICALS LLC60dce400-1138-4781-b621-1774c0dbb64a2023-05-17Adverse reactionsExact identifier
unii: 3X7931PO74
Sterile WaterSTERILE WATERHikma Pharmaceuticals USA Inc.b20a28b0-7dfa-42eb-9177-ec256d5a5ef72023-05-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCivica, Inc.3f49eedf-5bf5-4a95-b704-c956d860ca042023-04-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TreprostinilTREPROSTINILSandoz Inc473297ca-a872-4052-a053-87dc8f0d3c132023-04-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Insulin Diluting Medium for NovoLogWATER INJECTIONNovo Nordisk3a1e73a2-3009-40d0-876c-b4cb2be56fc52023-02-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Hydrocortisone AcetateHYDROCORTISONE ACETATEA-S Medication Solutions03321951-e338-4955-8622-0f5ea29c6cd92023-01-18Adverse reactionsExact identifier
unii: 3X7931PO74
Petrochemical DetoxCHELIDONIUM MAJUS, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, SYMPHYTUM OFFICINALE, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, CADMIUM SULPHURATUM, GELSEMIUM SEMPERVIRENS, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PLATINUM METALLICUM, LATRODECTUS MACTANSDeseret Biologicals, Inc.b38b492a-cf45-4aa2-ba7e-4573d2c4ebe52023-01-12WarningsExact identifier
unii: 6DC9Q167V3
Radiaura Skin RecoveryLIDOCAINE HCL - HYDROCORTISONE ACETATEPureTek Corporationc9502692-674d-e53f-e053-2a95a90a74b32023-01-11Warnings, Adverse reactionsExact identifier
unii: 3X7931PO74
RehydrateAVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADENParaDocs All Natural, Inc.648fab10-c46b-420f-a42c-6642009d83fb2023-01-10WarningsExact identifier
unii: 059QF0KO0R
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

Reported adverse events (FAERS/openFDA)#

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