FDA.reportPublic FDA data

Atti amour Rose Anti-Aging Repair Serum

Product NDC
84601-002
11-digit product format
846010002
Labeler code
84601
Product ID
84601-002_42fa26da-733c-64be-e063-6294a90a8727
Type
HUMAN OTC DRUG
Nonproprietary name
NIACINAMIDE, GLYCERIN
Dosage form
LIQUID
Route
TOPICAL
Labeler
RIVER SUNZ co.,Ltd
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-08-02
Substance
GLYCERIN; NIACINAMIDE
Active strength
5.96; 4 g/100mL; g/100mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-08-27 00:01 UTC · source 2025-08-26excluded productproduct84601-002IInactivated by FDAexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage84601-00284601-002-01IInactivated by FDAexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Atti amour Rose Anti-Aging Repair Serum
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCERIN5.96 g/100mL
NIACINAMIDE4 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PDC6A3C0OXInternal UNII lookup
25X51I8RD4Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1eb08f86-eb2a-7f29-e063-6294a90a0516Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2025-11-07Atti amour Rose Anti-Aging Repair Serum
2025-11-0784601-002 Atti amour Rose Anti-Aging Repair Serum
2025-07-29Atti amour Rose Anti-Aging Repair Serum
2025-07-2984601-002 Atti amour Rose Anti-Aging Repair Serum

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84601-002-01Atti amour Rose Anti-Aging Repair Serum30 mL in 1 BOTTLELIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84601-002ATTI AMOUR ROSE ANTI-AGING REPAIR SERUM (NIACINAMIDE, GLYCERIN) LIQUID [RIVER SUNZ CO.,LTD]1Current NDC, 1 package rows20240805_1eb08f86-eb2a-7f29-e063-6294a90a0516.zip

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 11 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daily MoisturizingDIMETHICONEAldi, Inc118a1a07-7283-4353-97b5-6ac3b1cc14302026-05-08Warnings, Adverse reactionsExact identifier
application number: M016
DoveANTIBACTERIAL CARE MOISTURIZING CREAMConopco Inc. d/b/a/ Unilever5150f48c-ff0c-ce39-e063-6394a90ad4242026-05-08WarningsExact identifier
application number: M016
Seedlings Diaper Rash CreamZINC OXIDEYoung Living Essential Oils, LC.4d8aeaba-ddb1-6f74-e054-00144ff88e882026-05-08WarningsExact identifier
application number: M016
Nail Repairs PatchesGLYCERINShantou Ximonth Biotechnology Co., Ltd.5120b708-047a-1182-e063-6394a90a74c32026-05-06WarningsExact identifier
application number: M016
AOAO Acne Buster Salicylic Acid Drying SerumZINC OXIDE,NIACINAMIDE,COLLOIDAL SULFUR,AZELAIC ACID,SALICYLIC ACID.Guangzhou Senmai Biotechnology Co.,Ltd.512185a5-5c1d-ef9f-e063-6394a90a81af2026-05-06WarningsExact identifier
application number: M016
AKOLKOL TOENAIL FUNGUS TREATMENTGLYCERINShantou Ximonth Biotechnology Co., Ltd.5121c341-e5e9-2b36-e063-6394a90a93b82026-05-06WarningsExact identifier
application number: M016
Beyond Good Diaper RashZINC OXIDEBabylist, Inc512b62df-4f08-d839-e063-6294a90ab52f2026-05-06WarningsExact identifier
application number: M016
Acne Buster Salicylic Acid Drying SerumZINC OXIDE,NIACINAMIDE,COLLOIDAL SULFUR,AZELAIC ACID,SALICYLIC ACID.Guangzhou Senmai Biotechnology Co.,Ltd.4c531280-bc5b-1cf2-e063-6394a90a034a2026-05-05WarningsExact identifier
application number: M016
PEGO Acne Buster Salicylic Acid Drying SerumZINC OXIDE,NIACINAMIDE,COLLOIDAL SULFUR,AZELAIC ACID,SALICYLIC ACID.Guangzhou Senmai Biotechnology Co.,Ltd.511eaced-c4d8-ae94-e063-6394a90a320e2026-05-05WarningsExact identifier
application number: M016
Rugby Gas reliefSIMETHICONERugby Laboratories9b84f74f-8609-489d-b411-3103afa1b5c22026-05-04WarningsExact identifier
application number: M016
Vitamin A and DPETROLATUMAldermed Inc.3f13a15c-8b64-48f0-a459-853b9097bc312026-05-04WarningsExact identifier
application number: M016
Zinc Oxide Skin ProtectantZINC OXIDE 20%Aldermed Inc.a55ac5b4-bac7-4d2a-8ac8-c3eaf7e89e522026-05-04WarningsExact identifier
application number: M016
Petroleum JellyWHITE PETROLATUMAldermed Inc.4e02af41-db86-46d8-a97d-332d84eced6f2026-05-04WarningsExact identifier
application number: M016
Daily MoisturizerLOTIONWalgreensfc65f673-b23d-1ffa-e053-6394a90a09662026-05-03WarningsExact identifier
application number: M016
Dry Skin HealingPETROLATUMWalgreen0397507d-4b6e-c679-e063-6294a90a0b332026-05-03WarningsExact identifier
application number: M016
Daily MoisturizerLOTIONWalgreenfc67037a-ed31-f678-e053-6394a90a71752026-05-03WarningsExact identifier
application number: M016
Skin ReliefLOTIONWalgreenfc678e80-e63d-e3fe-e053-6394a90aa7d62026-05-03WarningsExact identifier
application number: M016
Petroleum JellyWHITE PETROLATUMWalmart INCf76ceecc-ef11-3839-e053-6394a90a8d4a2026-05-03WarningsExact identifier
application number: M016
Herpecin LDIMETHICONE AND MERADIMATE AND OCTINOXATE AND OCTISALATE AND OXYBENZONEFocus Consumer Healthcare, LLC5b6ed4e9-3e69-c773-e053-2991aa0a7dfe2026-05-01WarningsExact identifier
application number: M016
CalamineFERRIC OXIDE REDRetail Business Services, LLC7291e175-a9b6-4c47-93ce-227ce11e45992026-04-30Warnings, Adverse reactionsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84601-002-018460100020130 mL in 1 BOTTLE (84601-002-01) 30 ml2024-08-02NoNoCurrent