FDA.reportPublic FDA data

APUREE Prorevive Maximum Strength Antifungal

Product NDC
84167-192
11-digit product format
841670192
Labeler code
84167
Product ID
84167-192_58860bba-91eb-c63f-e063-6394a90ac91c
Type
HUMAN OTC DRUG
Nonproprietary name
COLLOIDAL SULFUR
Dosage form
CREAM
Route
TOPICAL
Labeler
Guangzhou Meixi Biotechnology Co., Ltd.
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-08-08
Substance
UNDECYLENIC ACID; ZINC UNDECYLENATE
Active strength
15; 10 g/1; g/1
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
APUREE Prorevive Maximum Strength Antifungal
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
UNDECYLENIC ACID15 g/1
ZINC UNDECYLENATE10 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
K3D86KJ24NInternal UNII lookup
388VZ25DURInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2749266Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
58860baa-070a-7b73-e063-6294a90acdf0Available on FDA.report

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 19 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stage Fight Acne MaskSULFUR, RESORCINOLBioelements, Inc21ca8de4-28b5-425f-e063-6394a90a33402025-12-17WarningsExact identifier
application number: M006
Spot DefySULFURBioelements, Inc.6f35f950-8d04-4181-a897-5679fde1e2d92025-12-17WarningsExact identifier
application number: M006
BlemFreeSALICYLIC ACIDEquibal, Inc.d6720efc-dbbe-4304-bb31-972b506a08bf2025-12-17WarningsExact identifier
application number: M006
BlemfreeSALICYLIC ACIDEEquibal, Inc.424dba97-0d40-4801-9fec-4b80ab60f9002025-12-17WarningsExact identifier
application number: M006
Renu Laboratories Acne Sulphur LACNE SULFUR LOTIONRenu Laboratories, LLC13de0e4c-b134-41c0-e054-00144ff88e882025-12-16WarningsExact identifier
application number: M006
SUPER SPOT REMOVER ACNE TREATMENTSALICYLIC ACIDORIGINS NATURAL RESOURCES INC.a0aece76-008b-4af3-be39-13156acc73af2025-12-15WarningsExact identifier
application number: M006
DRx Blemish Clarifying MaskSULFURDr. Dennis Gross Skincare7093a8d4-1910-4b23-9d88-d3398db0916a2025-12-15WarningsExact identifier
application number: M006
e.l.f. PLZ Clarify Facial OilSALICYLIC ACIDe.l.f. Cosmetics, Inc.26cde11d-e05e-35a7-e063-6394a90a1fdf2025-12-14WarningsExact identifier
application number: M006
Image Clear Cell Acne Spot TreatmentSALICYLIC ACID ACNE GELSwiss-American CDMO, LLCf1b272ba-683e-4eff-a3ac-a046f547d5e52025-12-11WarningsExact identifier
application number: M006
Dr Mellaxeen SKIN SAVER ACNE RELIEF StickSALICYLIC ACIDLongway Lab Inc.45b85ebb-c00a-61df-e063-6294a90a11bc2025-12-11WarningsExact identifier
application number: M006
Dr.Mellaxeen SKIN SAVER DAILY ACNE ESSENTIALS KitSALICYLIC ACIDLongway Technology(Guangzhou)Co.,Ltd.45b89790-1056-b6a2-e063-6294a90a6f662025-12-11WarningsExact identifier
application number: M006
MULTI-ACTION CLEAR - ACNE CLEARING TREATMENT 2% SALICYLIC ACIDSALICYLIC ACIDStriVectin Operating Company, Inc.f1d93376-4fc2-751f-e053-2a95a90a68882025-12-09WarningsExact identifier
application number: M006
PowerSpot CleanseSULFURBluemercury443ae172-bacd-4122-8d78-d2214bcb02fd2025-12-09WarningsExact identifier
application number: M006
GM COLLIN PURACNESALICYLIC ACIDLaboratoires Dermo-Cosmetik Inc.2619cc3b-5246-4519-94c4-07e0338b273c2025-12-09WarningsExact identifier
application number: M006
Hero Cosmetics Pimple Correct Salicylic Acid Acne TreatmentSALICYLIC ACIDChurch & Dwight Co., Inc.869afe67-edae-4778-b990-08c2313d5aad2025-12-05WarningsExact identifier
application number: M006
XIMONTH Bee Venom All-In-One CreamSALICYLIC ACIDShantou Ximonth Biotechnology Co., Ltd.451e2c76-dd85-7b04-e063-6294a90afad32025-12-04WarningsExact identifier
application number: M006
Clear Future Deep Pore CleanserSALICYLIC ACIDArbonne International, LLC6f2a66d3-43ec-4bf6-b412-2bcf43f05ab92025-12-03WarningsExact identifier
application number: M006
Clear Future Intensive Spot TreatmentSALICYLIC ACIDArbonne International, LLC84435343-25c7-4aa1-9884-bd0fab2bbccf2025-12-03WarningsExact identifier
application number: M006
Adult AcnomelRESORCINOL, SULFURNUMARK BRANDS, INC90f80e35-095d-88f9-8ea3-0fd54f1e916c2025-12-03WarningsExact identifier
application number: M006
Good Molecules Maximum Strength Acne Gel CreamSALICYLIC ACIDGood Molecules, LLC33dcca56-d5bd-ff7b-e063-6394a90ad51f2025-12-01WarningsExact identifier
application number: M006

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84167-192-11841670192111 BAG in 1 BOX (84167-192-11) / 1 CREAM in 1 BAG1 bag2026-08-08NoNoCurrent