FDA.reportPublic FDA data

NDC 73028-401-01 - Hydrocortisone Acetate Pramoxine Hydrochloride

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
73028-401
Requested NDC
73028-401-01
Package NDCs from labels
73028-401-01, 73028-401-12
Manufacturer
Pageview Pharmaceuticals
Effective date
2022-02-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hydrocortisone Acetate Pramoxine Hydrochloride - Pageview PharmaceuticalsPageview Pharmaceuticals2022-02-01HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73028-401-122024-01-30C16284748780-11030e365-320c-111a-e063-dadaa90a10e2Hydrocortisone Acetate 25 mg and Pramoxine Hydrochloride 18 mg Suppositories

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73028-401-01Hydrocortisone Acetate Pramoxine Hydrochloride6 in 1 BLISTER PACKSUPPOSITORY61
73028-401-12Hydrocortisone Acetate Pramoxine Hydrochloride2 in 1 BOXSUPPOSITORY21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73028-401HYDROCORTISONE ACETATE PRAMOXINE HYDROCHLORIDE (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) SUPPOSITORY [PAGEVIEW PHARMACEUTICALS]1Legacy NDC, 2 package rows20220202_ac9617e7-0487-4ec8-8714-edcf967e9e50.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73028-401-01EA - Each73028-401b4bc1959-7f46-4b1b-a359-ea5f1693207512025-06-13
73028-401-12EA - Each73028-401168ffd51-64a7-4195-9e85-42d12c1cc7f412022-04-06

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 18 of 19 · 362 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HYDROCORTISONE ACETATEHYDROCORTISONE ACETATENivagen Pharmaceuticals, Inc.7743779d-1e42-4b23-bde5-0d77fe95bb2b2023-08-28Adverse reactionsExact identifier
unii: 3X7931PO74
hydrocortisone acetate pramoxine hclHYDROCORTISONE ACETATE PRAMOXINE HCLBryant Ranch Prepack0c28458a-cc56-4eea-89aa-d60659bd95682023-08-17Adverse reactionsExact identifier
unii: 88AYB867L5
unii: 3X7931PO74
Quality Choice Anti-itch MedicatedCALAMINE AND PRAMOXINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC5e07f26f-cfb6-57f9-e053-2991aa0a20082023-08-02WarningsExact identifier
unii: 88AYB867L5
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
unii: 88AYB867L5
unii: 3X7931PO74
Hydrocortisone AcetateHYDROCORTISONE ACETATEQUAGEN PHARMACEUTICALS LLC60dce400-1138-4781-b621-1774c0dbb64a2023-05-17Adverse reactionsExact identifier
unii: 3X7931PO74
Hydrocortisone AcetateHYDROCORTISONE ACETATEA-S Medication Solutions03321951-e338-4955-8622-0f5ea29c6cd92023-01-18Adverse reactionsExact identifier
unii: 3X7931PO74
Radiaura Skin RecoveryLIDOCAINE HCL - HYDROCORTISONE ACETATEPureTek Corporationc9502692-674d-e53f-e053-2a95a90a74b32023-01-11Warnings, Adverse reactionsExact identifier
unii: 3X7931PO74
hydrocortisone acetate pramoxine HClHYDROCORTISONE ACETATE, PRAMOXINE HCLPadagis Israel Pharmaceuticals Ltd982f0862-2be8-4a65-8b61-8f3a95ab59512022-05-31Adverse reactionsExact identifier
unii: 88AYB867L5
unii: 3X7931PO74
Hydrocortisone Acetate Pramoxine HclHYDROCORTISONE ACETATE PRAMOXINE HCLPadagis Israel Pharmaceuticals Ltd87a4c494-56f9-48f6-8592-d610c507a4fc2022-05-31Adverse reactionsExact identifier
unii: 88AYB867L5
unii: 3X7931PO74
Hydrocortisone AcetateHYDROCORTISONE ACETATEPadagis US LLC2fdb9940-6da8-49b0-a236-9817943f7a4b2022-05-31Adverse reactionsExact identifier
unii: 3X7931PO74
hydrocortisone acetate pramoxine hclHYDROCORTISONE ACETATE PRAMOXINE HCLPadagis Israel Pharmaceuticals Ltd9eea5875-d153-4bba-aee2-b1d1cd8b5e572022-05-31Adverse reactionsExact identifier
unii: 88AYB867L5
unii: 3X7931PO74
Hydrocortisone AcetateHYDROCORTISONE ACETATEAPNAR PHARMA LPcb60f2a6-8bab-c0f9-e053-2a95a90a422a2022-03-16Adverse reactionsExact identifier
unii: 3X7931PO74
d4f8a1fa-dcd1-4363-8df2-da07a5c162a6ac9617e7-0487-4ec8-8714-edcf967e9e502022-02-01Adverse reactionsExact identifier
spl id: d4f8a1fa-dcd1-4363-8df2-da07a5c162a6
spl set id: ac9617e7-0487-4ec8-8714-edcf967e9e50
CuadridermaBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE, AND PRAMOXINE HYDROCHLORIDEProMex LLC4fa99b96-ab4b-4523-82bc-343dbaf39fb62022-01-25WarningsExact identifier
unii: 88AYB867L5
Hydrocortisone AcetateHYDROCORTISONE ACETATEPatrin Pharma Inc.7c1d2c8c-26e2-432f-b983-505f259665a92021-12-22Adverse reactionsExact identifier
unii: 3X7931PO74

Reported adverse events (FAERS/openFDA)#

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