FDA.reportPublic FDA data

NDC 15054-0010-01 - SOHONOS

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
15054-0010
Requested NDC
15054-0010-01
Package NDCs from labels
15054-0010-1, 15054-0010-01
Manufacturer
Ipsen Biopharmaceuticals, Inc.
Effective date
2026-09-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SOHONOS - Ipsen Biopharmaceuticals, Inc.Ipsen Biopharmaceuticals, Inc.2026-09-24HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15054-0010-1SOHONOS1 in 1 CARTONCAPSULE12
15054-0010-1SOHONOS14 in 1 BLISTER PACKCAPSULE142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15054-0010SOHONOS (PALOVAROTENE) CAPSULE [IPSEN BIOPHARMACEUTICALS, INC.]2Current NDC, 2 package rows20250323_67dce406-7cc4-4d66-92de-ad18b6df0625.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
15054-0010-1EA - Each15054-001016fb2d70-322b-4a3b-970d-c057ca01ffaf12023-09-05

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 35 of 109 · 2,164 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Mineral Sun DefenseTITANIUM DIOXIDE, ZINC OXIDEHelen's Haven36c465ea-979b-9474-e063-6394a90ab3f82025-12-16Exact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEHelen's Haven36c4a27b-96e9-4f30-e063-6294a90a56552025-12-16Exact identifier
unii: 15FIX9V2JP
Mineral Sunscreen Non TintedTITANIUM DIOXIDE, ZINC OXIDESAN JOSE MEDICAL SPA37ef19e5-1775-a8d5-e063-6394a90acaef2025-12-16Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDEBABYFACE LLC36d69eb5-59b4-14a0-e063-6394a90a0a492025-12-16Exact identifier
unii: 15FIX9V2JP
Non Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEBABYFACE LLC36d6141c-6967-d779-e063-6294a90af0a72025-12-16Exact identifier
unii: 15FIX9V2JP
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEESTHETIC ACADEMY LLC36c043e0-fd6c-5f7a-e063-6294a90a88992025-12-16Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEESTHETIC ACADEMY LLC36c0c1ca-80a8-9d37-e063-6294a90a824f2025-12-16Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEESTHETIC ACADEMY LLC36c0f5df-6bfb-3c0d-e063-6294a90a2e5f2025-12-16Exact identifier
unii: 15FIX9V2JP
Total Eye 3-In-1 Renewal Therapy SPF 35TITANIUM DIOXIDE AND ZINC OXIDEColorescience4b116cc4-94d2-4bfc-b7f9-5f486a194c6c2025-12-16WarningsExact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Essential Brazilian Spa LLC3543a22c-34d5-e572-e063-6394a90ad5792025-12-15Exact identifier
unii: 15FIX9V2JP
Stellar Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEThe Essential Brazilian Spa LLC3bb6488c-d216-8742-e063-6394a90a16e22025-12-15WarningsExact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Essential Brazilian Spa LLC3bb8ee19-81b2-daed-e063-6394a90a0fb32025-12-15WarningsExact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Essential Brazilian Spa LLC3bb6cfd4-fa4a-d1d9-e063-6394a90a8e432025-12-15WarningsExact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Essential Brazilian Spa LLC35442ac0-c361-e08f-e063-6294a90a5cb22025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Essential Brazilian Spa LLC3543e85d-9bc7-b8ed-e063-6294a90ae7d32025-12-15Exact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Essential Brazilian Spa LLC3bc8593d-fc6c-04aa-e063-6394a90a6d562025-12-15WarningsExact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEMantra Wellness Spa3389b0a3-40f9-b411-e063-6394a90a99592025-12-15Exact identifier
unii: 15FIX9V2JP
Non Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEMILESTHETICS LLC39959db9-5ee1-a27c-e063-6394a90a1e102025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Mineral Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEMILESTHETICS LLC3995f556-20fe-3e64-e063-6294a90a5efe2025-12-15Exact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEMILESTHETICS LLC3995385b-b10b-ca5c-e063-6294a90af43f2025-12-15Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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