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 15 of 31 · 613 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SionBiotext HydrocortisoneHYDROCORTISONE ACETATE 1%Sion Biotext Medical Ltd35073eae-26fe-2bb5-e063-6294a90ab56a2025-05-13WarningsExact identifier
unii: 3X7931PO74
Multi ActionBACITRACINZINC,NEOMYCINSULFATE,POLYMYXINBSULFATE,PRAMOXINEHCLTrifecta Pharmaceutical USA LLCb98082f3-be95-49fb-e053-2a95a90a37b82025-05-13WarningsExact identifier
unii: 88AYB867L5
Leader Triple antibiotic and pain reliefBACITRACIN,NEOMYCIN,POLYMXIN, PRAMOXINECardinal Health 110 dba LEADERf4c521d9-dd05-1c23-e053-2995a90a6e2c2025-05-13WarningsExact identifier
unii: 88AYB867L5
TripleantibioticointmentandpainreliefBACITRACIN,NEOMYCIN,POLYMXIN, PRAMOXINETrifecta Pharmaceuticals USA34f1db74-6506-d53d-e063-6394a90ac4002025-05-12WarningsExact identifier
unii: 88AYB867L5
Ivarest Poison Ivy Removal and Itch ReliefPRAMOXINE HYDROCHLORIDEBlistex Inc.dedbf5d9-0f86-4f32-8321-da86c9838c0a2025-04-29WarningsExact identifier
unii: 88AYB867L5
PROCORT1.85% HYDROCORTISONE ACETATE - 1.15% PRAMOXINE HCI CREAMWomens Choice Pharmaceuticals LLC9e899b72-a16e-4b55-93b5-ab5baec37d502025-04-28Adverse reactionsExact identifier
unii: 88AYB867L5
unii: 3X7931PO74
PROCTOFOAM HCPRAMOXINE HYDROCHLORIDE HYDROCORTISONE ACETATEViatris Specialty LLC3831e931-ec0a-11e3-ac10-0800200c9a662025-04-15Warnings, Adverse reactionsExact identifier
unii: 88AYB867L5
unii: 3X7931PO74
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
Post Treatment Repair CreamHYDROCORTISONEVege Labs LLC.302d4327-354b-a252-e063-6394a90a20b62025-03-12WarningsExact identifier
unii: 3X7931PO74
Bestmade Natural Products BM235ACONITE, CACTUS, CRATAEGUS, ALFALFA, CHIONANTHUS, P. GLYCOLBestmade Natural Products2f82818a-fc34-75e5-e063-6394a90a03012025-03-04WarningsExact identifier
unii: 6DC9Q167V3
Thera Plus HemorrhoidalGLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDEFOURSTAR GROUP USA, INC.87143a7a-7b2d-4b67-afda-2355697e73002025-03-04WarningsExact identifier
unii: 88AYB867L5
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R
HYDROCORTISONE ACETATEHYDROCORTISONE ACETATEGolden State Medical Supply, Inc.fe42cde7-b3ac-2014-e053-6394a90a0f672025-02-24Adverse reactionsExact identifier
unii: 3X7931PO74
hydrocortisone acetate pramoxine HClHYDROCORTISONE ACETATE, PRAMOXINE HCLBryant Ranch Prepackc95b9248-b4cc-43ce-acd2-fe20972f87ca2025-02-21Adverse reactionsExact identifier
unii: 88AYB867L5
unii: 3X7931PO74
FEELSHION Glycolic Acid Exfoliating Face PadsPROPYLENE GLYCOL,ARGININE,LACTIC ACID,SALICYLIC ACID,GLYCOLIC ACIDBeijing JUNGE Technology Co., Ltd.2e79678c-1ce4-25cf-e063-6394a90a133c2025-02-19WarningsExact identifier
unii: 6DC9Q167V3
Advanced Eye Relief Eye WashWATER SOLUTIONBausch & Lomb Incorporated9caccce1-4530-441d-bf76-244edeb9dedc2025-02-17WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products, Inc.2d90c8e8-f479-3535-e063-6394a90af1222025-02-07WarningsExact identifier
unii: 059QF0KO0R
Bestmade Natural Products BM63CEANOTHUS, KALI MUR, KALI ARS, OOPHRINUM, SELENIUM, THALLIUM, WEISBADENBestmade Natural Products2cea4552-3700-3da3-e063-6294a90a14b52025-01-30WarningsExact identifier
unii: 059QF0KO0R
ZCort UltraHYDROCORTISONE ACETATE 1%RxDino, LLCb68f8ada-58e8-e8e4-e053-2a95a90ab02d2025-01-29WarningsExact identifier
unii: 3X7931PO74
Lidocaine HCl - Hydrocortisone AcetateLIDOCAINE HCL AND HYDROCORTISONE ACETATEPureTek Corporation3a24be46-df26-477e-b909-04dd14d0a0142025-01-29Warnings, Adverse reactionsExact identifier
unii: 3X7931PO74

Reported adverse events (FAERS/openFDA)#

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