FDA.reportPublic FDA data

Acne Relief Cream

Product NDC
84509-110
11-digit product format
845090110
Labeler code
84509
Product ID
84509-110_53008b89-89ac-7650-e063-6294a90ac16c
Type
HUMAN OTC DRUG
Nonproprietary name
NIACINAMIDE,SALICYLIC ACID,CENTELLA ASIATICA ROOT,COPTIS CHINENSIS ROOT
Dosage form
CREAM
Route
TOPICAL
Labeler
Guangzhou Senmai Biotechnology Co.,Ltd.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-05-30
Substance
NIACINAMIDE; COPTIS CHINENSIS ROOT; CENTELLA ASIATICA ROOT; SALICYLIC ACID
Active strength
400; 4; 48; 152 mg/20g; mg/20g; mg/20g; mg/20g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
Acne Relief Cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NIACINAMIDE400 mg/20g
COPTIS CHINENSIS ROOT4 mg/20g
CENTELLA ASIATICA ROOT48 mg/20g
SALICYLIC ACID152 mg/20g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
25X51I8RD4Internal UNII lookup
CXS4LJR7ELInternal UNII lookup
8MXU1P42J0Internal UNII lookup
O414PZ4LPZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
53008b89-89ab-7650-e063-6294a90ac16cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

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 33 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetaphil Soothing Gel CreamALLANTOINGalderma Laboratories, L.P.bab404f0-2f7a-4bac-b053-cbdc81c029b52025-11-24WarningsExact identifier
application number: M016
health beyond VITAMINS ADPETROLATUMNantong Health & Beyond Hygienic Products Inc.de87da51-cf92-402c-b60f-5f28d17241242025-11-23WarningsExact identifier
application number: M016
MedlineWHITE PETROLATUMMedline Industries, LP00766a7b-797e-dd15-e063-6394a90af9ac2025-11-20WarningsExact identifier
application number: M016
Itch Eraser SensitiveSODIUM BICARBONATETender Corporation d/b/a Adventure Ready Brands2250525a-45c2-42ea-e063-6394a90ac0012025-11-18WarningsExact identifier
application number: M016
Moisture Barrier CreamPETROLATUM, ZINC OXIDEDerma Sciences Canada Inc.43e01e22-7872-8e24-e063-6394a90a17ef2025-11-18WarningsExact identifier
application number: M016
terrasil Bed Sore and Pressure Sore ReliefALLANTOINAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutionsd0e4a492-f833-4e92-bd4a-b0a07ce9a69e2025-11-18WarningsExact identifier
application number: M016
terrasil Foot Ulcer and Sore ReliefALLANTOINAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions2776080b-3ddb-ad6c-e063-6394a90a93e02025-11-18WarningsExact identifier
application number: M016
After Bite KidsSODIUM BICARBONATETender Corporation d/b/a Adventure Ready Brands226c1420-d771-204f-e063-6294a90af9f62025-11-18WarningsExact identifier
application number: M016
Petroleum with CocoaWHITE PETROLATUMQUALITY CHOICE (Chain Drug Marketing Association)280d4bdb-30d3-44f2-9159-3aa9a1de9a5f2025-11-17WarningsExact identifier
application number: M016
After Bite X TechSODIUM BICARBONATEAdventure Ready Brandse9e49ab4-3e1f-9fd4-e053-2a95a90a775a2025-11-17WarningsExact identifier
application number: M016
Diaper Rash skin protectantLANOLIN AND PETROLATUMUniversal Distribution Centre LLC29b5475d-6085-cfe6-e063-6294a90a7e742025-11-17WarningsExact identifier
application number: M016
DERMOGENZINC OXIDEKRAMER NOVIS38e02d1c-c143-4da6-ad32-a3ce2861aac52025-11-14WarningsExact identifier
application number: M016
Welmedix HomeCare PRO Rapid Relief Rash CreamPETROLATUM, ZINC OXIDEWelmedix LLC4382a6b4-0b1f-0822-e063-6394a90adffc2025-11-14WarningsExact identifier
application number: M016
Petroleum with CocoaWHITE PETROLATUMQUALITY CHOICE (Chain Drug Marketing Association)086b6563-cb73-4874-aa42-028f5e81b60d2025-11-13WarningsExact identifier
application number: M016
Welmedix HomeCare PRO Fragile Skin ProtectantPETROLATUMWelmedix LLC43840785-3640-9813-e063-6394a90a77702025-11-13WarningsExact identifier
application number: M016
Petroleum Jelly Baby Fresh Scent 3.53ozPETROLATUMRejoice International Corp.1309926f-ecd9-635e-e063-6294a90aaab32025-11-11WarningsExact identifier
application number: M016
Petroleum Jelly Fragrance Free 3.53ozPETROLATUMRejoice International Corp.12f8d9cc-aa77-e034-e063-6394a90a94dd2025-11-11WarningsExact identifier
application number: M016
Petroleum Jelly Cocoa Butter Scent 3.53ozPETROLATUMRejoice International Corp.1309b15b-5236-6e9f-e063-6294a90afe112025-11-11WarningsExact identifier
application number: M016
ODLUMIVIE Tremella Revitalizing CleanserTREMELLA FUCIFORMIS WHOLEODLUMIVIE435e4736-bcef-c227-e063-6394a90a53d52025-11-11WarningsExact identifier
application number: M016
ODLUMIVIE Peptide CalmMistPALMITOYL TRIPEPTIDE-8ODLUMIVIE435e6717-5fbf-5cb2-e063-6294a90a40d72025-11-11WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84509-110-018450901100120 g in 1 BOTTLE (84509-110-01) 20 g2026-05-30NoNoCurrent