Spot Acne Treatment Oil Free 0.75oz

Product NDC
57337-168
11-digit product format
573370168
Labeler code
57337
Product ID
57337-168_212f77ca-82d4-6a78-e063-6394a90aed32
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
CREAM
Route
TOPICAL
Labeler
Rejoice International Corp.
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-09-02
Substance
SALICYLIC ACID
Active strength
2 g/100g
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
Spot Acne Treatment Oil Free 0.75oz
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID2 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O414PZ4LPZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
317152Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
212f77ca-82d3-6a78-e063-6394a90aed32Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-168-01Spot Acne Treatment Oil Free 0.75oz21 g in 1 TUBECREAM211

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-168SPOT ACNE TREATMENT OIL FREE 0.75OZ (SALICYLIC ACID) CREAM [REJOICE INTERNATIONAL CORP.]1Current NDC, 1 package rows20240904_212f77ca-82d3-6a78-e063-6394a90aed32.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 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317152salicylic acid 2 % Topical CreamPSN212f77ca-82d3-6a78-e063-6394a90aed321
317152salicylic acid 20 MG/ML Topical CreamSCD212f77ca-82d3-6a78-e063-6394a90aed321
317152salicylic acid 2 % Topical CreamSY212f77ca-82d3-6a78-e063-6394a90aed321

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
57337-168-015733701680121 g in 1 TUBE (57337-168-01) 21 g2024-09-02NoNoCurrent