FDA.reportPublic FDA data

Acne Fighting Spot Gel

Product NDC
76354-414
11-digit product format
763540414
Labeler code
76354
Product ID
76354-414_41b43bda-b96f-5b9e-e063-6394a90ad8a9
Type
HUMAN OTC DRUG
Nonproprietary name
SALICYLIC ACID
Dosage form
GEL
Route
TOPICAL
Labeler
e.l.f. Cosmetics, Inc
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-02-25
Substance
SALICYLIC ACID
Active strength
10 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
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 Fighting Spot Gel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID10 mg/mL

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
251380Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
eca08910-58b9-4ce6-8e97-4b97c30784f5Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76354-414-01Acne Fighting Spot Gel7.5 mL in 1 TUBEGEL7.56
76354-414-01Acne Fighting Spot Gel1 in 1 CARTONGEL16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76354-414ACNE FIGHTING SPOT GEL (SALICYLIC ACID) GEL [E.L.F. COSMETICS, INC]5Current NDC, Legacy NDC, 2 package rows20241108_eca08910-58b9-4ce6-8e97-4b97c30784f5.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 38 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TREAT SO DEEP ACNE-FIGHTING TREATMENTSALICYLIC ACIDASPIRE BRANDS INCd18b4f15-9ea1-4d76-a1e3-a0be1c5bb58a2024-12-06WarningsExact identifier
application number: M006
Oxy Maximum Strength Rapid Spot TreatmentOXY MAXIMUM STRENGTH RAPID SPOT TREATMENTThe Mentholatum Company28886273-a71a-46ea-e063-6394a90ac11d2024-12-05WarningsExact identifier
application number: M006
Dermaclear Spot TreatmentBENZOYL PEROXIDEAllure Labs Inc45a93c47-552f-4660-a37c-7a8cceac2d8e2024-12-05WarningsExact identifier
application number: M006
DermaClear PadsSALICYLIC ACIDAllure Labs0c6624fd-88f9-402c-8ac2-bc278242b4842024-12-05WarningsExact identifier
application number: M006
DermaClear BHA Spot TreatmentSALICYLIC ACIDAllure Labsb629cb05-548e-4d60-e053-2a95a90aeefb2024-12-05WarningsExact identifier
application number: M006
Acne Treatment Maximum StrengthSALICYLIC ACIDYoung Living Essential Oils, LC756a52ff-161d-4b6e-933b-49bce885d9982024-12-04WarningsExact identifier
application number: M006
DermaClear SerumSALICYLIC ACIDAllure Labs Inc487a7d1c-0f98-4d36-bfe9-c12bcda8d0b32024-12-04WarningsExact identifier
application number: M006
Dermaclear MaskSALICYLIC ACIDAllure Labs Inc,9429f477-a916-49c9-bf04-1cf591af5c7f2024-12-04WarningsExact identifier
application number: M006
Clear System Clarifying Gel CleanserSALICYLIC ACIDBentley Laboratories, LLC08248e40-aa71-4dfb-8a75-af8886ccb9762024-12-04WarningsExact identifier
application number: M006
DermaClear BHA CleanserSALICYLIC ACIDAllure Labs Incbfeced33-a630-4f1d-9ecf-33450bd26ae92024-12-03WarningsExact identifier
application number: M006
PCA SKIN Intensive Clarity TreatmentSALICYLIC ACIDCP Skin Health Group, Inc.7bd6edc0-941e-492d-8b3c-4e8b3425f9292024-12-03WarningsExact identifier
application number: M006
PCA SKIN BPO CleanserBENZOYL PEROXIDECP Skin Health Group, Inc.eb55cc26-cf47-4e9e-b7a8-23ef82aecce22024-12-03WarningsExact identifier
application number: M006
PCA SKIN AcneBENZOYL PEROZIDECP Skin Health Group, Inc.257bd9dd-93f9-4996-8478-8198be3ef6832024-12-03WarningsExact identifier
application number: M006
PCA GelSALICYLIC ACIDCP Skin Health Group, Inc396b4675-451f-48b2-b139-19508434e0fe2024-12-03WarningsExact identifier
application number: M006
CliniCalmHYDROCORTISONECP Skin Health Group, Inc.febcf7e8-668c-a5c9-e053-6394a90aec392024-12-03WarningsExact identifier
application number: M006
Alumier MD Acne Clarifying CleanserSALICYLIC ACIDAlumier Labs87747f82-9018-ab34-e053-2995a90a68082024-12-01WarningsExact identifier
application number: M006
Acne Control Face WashSALICYLIC ACIDBentley Laboratories, LLC068c5fef-cdc5-49f4-9372-9cfdd07508b82024-11-28WarningsExact identifier
application number: M006
Acne Control Body WashSALICYLIC ACIDBentley Laboratories, LLC3db0f885-4c08-4678-8533-ba2025bf7d482024-11-28WarningsExact identifier
application number: M006
Neutrogena Stubborn Blackheads Daily SerumSALICYLIC ACIDKenvue Brands LLCc0992ceb-5f7a-4c8f-a43f-7a300bd6bbf12024-11-26WarningsExact identifier
application number: M006
Neutrogena Stubborn Acne Spot DryingSULFURKenvue Brands LLCdffe9bf4-a8a2-4fa0-e053-2995a90abcb32024-11-26WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251380salicylic acid 1 % Topical GelPSNeca08910-58b9-4ce6-8e97-4b97c30784f56
251380salicylic acid 0.01 MG/MG Topical GelSCDeca08910-58b9-4ce6-8e97-4b97c30784f56
251380salicylic acid 1 % Topical GelSYeca08910-58b9-4ce6-8e97-4b97c30784f56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76354-414-01763540414011 TUBE in 1 CARTON (76354-414-01) / 7.5 mL in 1 TUBE1 tube2022-02-250000-00-00NoNoCurrent