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 27 of 31 · 604 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sheffield Triple Antibiotic Plus Pain ReliefBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, PRAMOXINE HYDROCHLORIDESheffield Pharmaceuticals LLC485a779c-017b-4064-a446-e5073c1bdb072023-11-20WarningsExact identifier
unii: 88AYB867L5
HydrocortisoneANTIPRURITIC (ANTI-ITCH)BluePoint Laboratoriesd6523993-d781-cdbc-e053-2a95a90af1912023-11-17WarningsExact identifier
unii: 3X7931PO74
SIMPLE PROMISE Simple H Hemorrhoid Relief CreamPHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDESIMPLE PROMISE PTE LTDf6622caa-3b31-9b07-e053-2a95a90a8a512023-11-06WarningsExact identifier
unii: 88AYB867L5
Hydrocortisone AcetateHYDROCORTISONE ACETATEBentlin Products LLC4346351c-8e11-46ae-b428-98d17f55beb92023-10-30WarningsExact identifier
unii: 3X7931PO74
calahistCALAMINE AND PRAMOXINE HYDROCHLORIDEWALGREEN COMPANYfed45e06-cc53-fbc5-e053-6294a90a1b192023-10-27WarningsExact identifier
unii: 88AYB867L5
calahist clearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEWALGREEN COMPANYfed469c2-fe13-6726-e053-6394a90a5f512023-10-27WarningsExact identifier
unii: 88AYB867L5
Family WellnessGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, PETROLATUMFRONT PHARMACEUTICAL PLCeb1785f4-5876-443b-b175-9b59d65d1a482023-10-26WarningsExact identifier
unii: 88AYB867L5
Family Wellness Antiseptic and Pain ReliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, PRAMOXINE HYDROCHLORIDEFRONT PHARMACEUTICAL PLCcb7fdcde-2bd8-4834-ba4e-4d6fd15125992023-10-26WarningsExact identifier
unii: 88AYB867L5
CVS Health Hemorrhoidal CreamGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMFRONT PHARMACEUTICAL PLCcb448d78-553c-4e65-80c5-d4b31d7b36612023-10-26WarningsExact identifier
unii: 88AYB867L5
Hemorrhoidal CreamGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUMCardinal Health 110, LLC. dba Leader85a51d5c-679e-1959-e053-2a91aa0a76d52023-10-25WarningsExact identifier
unii: 88AYB867L5
Family WellnessGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, PETROLATUMZhejiang Jingwei Pharmaceutical Co., Ltd.fde9cd90-d63c-4058-b46e-511fecea36ec2023-10-24WarningsExact identifier
unii: 88AYB867L5
CVS Itch relief moisturizingPRAMOXINE HCL 1%CVS Healthf3a753fc-f448-6bba-e053-2a95a90a8e1b2023-10-18WarningsExact identifier
unii: 88AYB867L5
Hemorrhoidal Pain Relief with Aloe and VitaminEHEMORRHOIDAL PAIN RELIEF WITH ALOE AND VITAMINENeilMed pharmaceuticals Inc.076b5021-8ba0-0204-e063-6294a90a33372023-10-11WarningsExact identifier
unii: 88AYB867L5
ANUBISMEDHA HYALURONICANUBIS COSMETICS SLeac771e2-4c1b-3808-e053-2995a90ac5fc2023-09-05WarningsExact identifier
unii: 6DC9Q167V3
unii: 059QF0KO0R
unii: 936JST6JCN
AnubisMedSPF 50 BROAD SPECTRUM PROTECTION FLUID EMULSIONANUBIS COSMETICS SLe99d92c4-8768-9c0a-e053-2a95a90a609e2023-09-05WarningsExact identifier
unii: 6DC9Q167V3
unii: 059QF0KO0R
AnubisMedAZELAIC ACID, SALICYLIC ACIDANUBIS COSMETICS SLebf3153d-30f5-54e4-e053-2995a90a74b12023-09-05WarningsExact identifier
unii: 6DC9Q167V3
unii: 059QF0KO0R
AnubisMedGLYCOLIC ACID, CITRIC ACID, LACTIC ACID, KOJIC ACIDANUBIS COSMETICS SLeca95dde-cb57-2ab6-e053-2995a90af84f2023-09-05WarningsExact identifier
unii: 6DC9Q167V3
unii: 059QF0KO0R
AnubisMedSODIUM BICARBONATE, ALOE BARBADENSIS LEAF JUICE, IMIDAZOLIDINYL UREAANUBIS COSMETICS SLebf4b3ab-34e1-185a-e053-2a95a90ace3a2023-09-05WarningsExact identifier
unii: 059QF0KO0R
LipotoxSQUALENE, CHOLESTERINUM, ESTRADIOL, PROGESTERONE, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM,BioActive Nutritional, Inc.a1538692-ca00-4e52-9b7e-409767ee27e12023-09-05WarningsExact identifier
unii: 8CRQ2TH63M
unii: 1VPU26JZZ4
Anubis BarcelonaGLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICEANUBIS COSMETICS SLeb651769-4d98-2b3b-e053-2a95a90a36b02023-09-01WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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