FDA.reportPublic FDA data

ELF ACNE Fighting Spot Gel with Aloe Clear

Product NDC
76354-616
11-digit product format
763540616
Labeler code
76354
Product ID
76354-616_26420a39-264e-eeb4-e063-6294a90a16cf
Type
HUMAN OTC DRUG
Nonproprietary name
SALICYLIC ACID
Dosage form
GEL
Route
TOPICAL
Labeler
e.l.f. Cosmetics, Inc
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-10-20
Substance
SALICYLIC ACID
Active strength
1 g/100mL
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
ELF ACNE Fighting Spot Gel with Aloe Clear
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID1 g/100mL

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
6ab34d5e-4439-4c64-ad0d-6c8641109c38Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76354-616-01ELF ACNE Fighting Spot Gel with Aloe Clear6 mL in 1 BOTTLEGEL65

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZELF ACNE FIGHTING SPOT GEL WITH ALOE CLEAR (SALICYLIC ACID) GEL [J. A. COSMETICS U.S. INC]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZELF ACNE FIGHTING SPOT GEL WITH ALOE CLEAR (SALICYLIC ACID) GEL [J. A. COSMETICS U.S. INC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MELF ACNE FIGHTING SPOT GEL WITH ALOE CLEAR (SALICYLIC ACID) GEL [J. A. COSMETICS U.S. INC]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XELF ACNE FIGHTING SPOT GEL WITH ALOE CLEAR (SALICYLIC ACID) GEL [J. A. COSMETICS U.S. INC]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RAELF ACNE FIGHTING SPOT GEL WITH ALOE CLEAR (SALICYLIC ACID) GEL [J. A. COSMETICS U.S. INC]1
C13-14 ISOPARAFFININACTIVE INGREDIENTE4F12ROE70ELF ACNE FIGHTING SPOT GEL WITH ALOE CLEAR (SALICYLIC ACID) GEL [J. A. COSMETICS U.S. INC]1
CAMELLIA SINENSIS WHOLEINACTIVE INGREDIENTC5M4585ZBZELF ACNE FIGHTING SPOT GEL WITH ALOE CLEAR (SALICYLIC ACID) GEL [J. A. COSMETICS U.S. INC]1
CAMPHOR OILINACTIVE INGREDIENT75IZZ8Y727ELF ACNE FIGHTING SPOT GEL WITH ALOE CLEAR (SALICYLIC ACID) GEL [J. A. COSMETICS U.S. INC]1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PELF ACNE FIGHTING SPOT GEL WITH ALOE CLEAR (SALICYLIC ACID) GEL [J. A. COSMETICS U.S. INC]1
LAURETH-7INACTIVE INGREDIENTZ95S6G8201ELF ACNE FIGHTING SPOT GEL WITH ALOE CLEAR (SALICYLIC ACID) GEL [J. A. COSMETICS U.S. INC]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TELF ACNE FIGHTING SPOT GEL WITH ALOE CLEAR (SALICYLIC ACID) GEL [J. A. COSMETICS U.S. INC]1
POLYACRYLAMIDE (10000 MW)INACTIVE INGREDIENTE2KR9C9V2IELF ACNE FIGHTING SPOT GEL WITH ALOE CLEAR (SALICYLIC ACID) GEL [J. A. COSMETICS U.S. INC]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUELF ACNE FIGHTING SPOT GEL WITH ALOE CLEAR (SALICYLIC ACID) GEL [J. A. COSMETICS U.S. INC]1
TEA TREE OILINACTIVE INGREDIENTVIF565UC2GELF ACNE FIGHTING SPOT GEL WITH ALOE CLEAR (SALICYLIC ACID) GEL [J. A. COSMETICS U.S. INC]1
WATERINACTIVE INGREDIENT059QF0KO0RELF ACNE FIGHTING SPOT GEL WITH ALOE CLEAR (SALICYLIC ACID) GEL [J. A. COSMETICS U.S. INC]1
WITCH HAZELINACTIVE INGREDIENT101I4J0U34ELF ACNE FIGHTING SPOT GEL WITH ALOE CLEAR (SALICYLIC ACID) GEL [J. A. COSMETICS U.S. INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76354-616ELF ACNE FIGHTING SPOT GEL WITH ALOE CLEAR (SALICYLIC ACID) GEL [E.L.F. COSMETICS, INC]5Current NDC, Legacy NDC, 1 package rows20241108_6ab34d5e-4439-4c64-ad0d-6c8641109c38.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 3 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antifungal Psoriasis Shampoo.SALICYLIC ACID 2%Trovina Co. Ltd5512ac82-e3c5-37e6-e063-6294a90a92d62026-07-01WarningsExact identifier
application number: M032
Anti-fungalANTI-FUNGAL SHAMPOOShenzhen Chaoxiji Technology Co.,Ltd.555cb4fa-6f59-fa69-e063-6394a90a1db62026-06-28WarningsExact identifier
application number: M032
RoyceDerm Seborrheic Scalp .spray.SALICYLIC ACID 2%RoyceDerm LLC55246263-7345-ba65-e063-6294a90ab1632026-06-26WarningsExact identifier
application number: M032
CeraVe Anti-Dandruff Hydrating ConditionerPYRITHIONE ZINCLOreal USA Products Inc552926da-0dfb-4248-e063-6294a90ab4a82026-06-26WarningsExact identifier
application number: M032
Dermoia Seborrheic Dermatitis Selenium SulfideSELENIUM SULFIDETREASUREWISE LLC04b8532e-44a7-4eaf-a46d-87611ec93c242026-06-23WarningsExact identifier
application number: M032
Dermgentle Seborrheic Scalp SerumPYRITHIONE ZINCDermgentle LLC54a0901a-404f-ea0e-e063-6294a90a6dc72026-06-19WarningsExact identifier
application number: M032
Silvagle Selenium Sulfide Anti DandruffShampooSELENIUM SULFIDEGUANGZHOU BAOSIJIE BIOTECHNOLOGY CO., LTD54885ae3-7e2f-7bd2-e063-6394a90a97fe2026-06-18WarningsExact identifier
application number: M032
Pharmlitalia Psoriasis TreatmentSALICYLIC ACIDFoshan Sugar Max Cosmetics CO.,Ltd845a82f6-7d0e-416d-b5b0-bf788dca2f542026-06-18WarningsExact identifier
application number: M032
anti dandruff SHAMPOO473mlPYRITHIONE ZINCGuangdong Quaker Daily Chemical Co., LTD5459e831-41e7-f1c7-e063-6394a90ae0982026-06-16WarningsExact identifier
application number: M032
ANTI DANDRUFF SHAMPOO473mlPYRITHIONE ZINCGuangdong Quaker Daily Chemical Co., LTD545780f9-a202-95e9-e063-6394a90a982f2026-06-15WarningsExact identifier
application number: M032
Swiftalyn Antifungal Scalp Shampoo.SALICYLIC ACID 2%GENUINE INNOVATION LTD53f84e9f-ecc1-dfc2-e063-6394a90af2432026-06-11WarningsExact identifier
application number: M032
Anti-DandruffZINC PYRITHIONEMEERAY COSMETICS CO., LTD.f5b2d9f2-ff29-2da1-e053-2995a90a68f32026-06-08WarningsExact identifier
application number: M032
Psoriasin Deep MoisturizingCOAL TARKobayashi Healthcare International, Inc.8bb4a84f-dd80-cbbc-e053-2a95a90a04752026-06-08WarningsExact identifier
application number: M032
Head and Shoulders Hutchs Cooling RushPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company5383143a-f930-46f8-e063-6294a90a3a752026-06-05WarningsExact identifier
application number: M032
Head and Shoulders Double Coverage 2in1PYRITHIONE ZINCThe Procter & Gamble Manufacturing Company53835f68-44d8-b1af-e063-6294a90acae92026-06-05WarningsExact identifier
application number: M032
Head and Shoulders Polamalu s Hall of Fame HairPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company53839833-d1c2-fa3b-e063-6394a90a6bd92026-06-05WarningsExact identifier
application number: M032
RENUEVO ANTI-DAMDRUFFZINC PYRITHIONELEON UP GLOBAL HOLDING CORP5387b840-ad0a-4c20-e063-6294a90a59e32026-06-05WarningsExact identifier
application number: M032
CVS Health MAXIMUM STRENGTH Dandruff Medicated Anti-Seborrheic Dermatitis, anti-dandruffSELENIUM SULFIDECVS Health307e4b16-10ab-44f4-86b9-709d10566d4c2026-06-04WarningsExact identifier
application number: M032
Minoxidil Hair Growth SerumMINOXIDILShenzhen Deshijian Medical Equipment Co., Ltd535cdf78-90bc-86b4-e063-6294a90a2c202026-06-04WarningsExact identifier
application number: M032
Dermaharmony Unscented BarSALICYLIC ACIDD3 Development, Inc.52f5885f-2a40-c3f5-e063-6294a90a434e2026-05-29WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251380salicylic acid 1 % Topical GelPSN6ab34d5e-4439-4c64-ad0d-6c8641109c385
251380salicylic acid 0.01 MG/MG Topical GelSCD6ab34d5e-4439-4c64-ad0d-6c8641109c385
251380salicylic acid 1 % Topical GelSY6ab34d5e-4439-4c64-ad0d-6c8641109c385

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76354-616-01763540616016 mL in 1 BOTTLE (76354-616-01) 6 ml2015-10-200000-00-00NoNoCurrent