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 19 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PHARMBANNER Anti-Fungal Shampoo.ANTI-FUNGAL SHAMPOOShenzhen Xinxin Yunhai Technology Co., Ltd.383926b7-997b-af1e-e063-6394a90a506d2025-06-23WarningsExact identifier
application number: M032
Brickell Mens Products Relieving Anti-DandruffSALICYLIC ACIDBRICKELL BRANDS LLC7ba3b13b-cb78-4df8-8719-c88e556643b42025-06-16WarningsExact identifier
application number: M032
VENROCKPIROCTONE OLAMINE AND SALICYLIC ACIDGuangzhou Oupeng Cosmetics Co., Ltd.372feca7-f6f1-cd38-e063-6294a90a3bfe2025-06-12WarningsExact identifier
application number: M032
Neutrogena T/Sal TherapeuticSALICYLIC ACIDKenvue Brands LLC54707f0f-6025-4dc3-8be8-7a38bb1363b82025-06-05WarningsExact identifier
application number: M032
Vichy Laboratoires Dercos Salicylic Acid Antidandruff Water to FoamSALICYLIC ACIDPRODUCTOS CAPILARES L'OREAL SAaae04d08-9d0c-43bd-89c2-741884de3bea2025-06-04WarningsExact identifier
application number: M032
Vichy Laboratoires Dercos Salicylic Acid Antidandruff Water to FoamSALICYLIC ACIDL'Oreal USA Products Incbcffd505-82bd-45ce-9ad0-64a9e63f62b52025-06-04WarningsExact identifier
application number: M032
UCHOIZE S2 Balance Anti-DandruffUCHOIZE S2 BALANCE ANTI-DANDRUFF SHAMPOODreamwise International Corp36a5efa8-0617-868d-e063-6394a90a17052025-06-03WarningsExact identifier
application number: M032
DermaD ATOPIC DERMATITIS TherapeuticSALICYLIC ACIDChen Cohen Industries Inc.d872a4ee-554e-4bca-acb1-3bbf57dc690b2025-05-29WarningsExact identifier
application number: M032
DermaD JOCK ITCH TherapeuticSALICYLIC ACIDChen Cohen Industries Inc.c8c0449c-11f9-4434-a91c-b690d67808202025-05-29WarningsExact identifier
application number: M032
DermaD Psoriasis TherapeuticSALICYLIC ACIDChen Cohen Industries Inc.e52c647b-8cdc-4023-af22-fbfb84ea0ada2025-05-27WarningsExact identifier
application number: M032
DermaER Psoriasis TherapeuticSALICYLIC ACIDChen Cohen Industries Inc.f62e6c5e-6e80-4b75-a0b1-c893224d9ce42025-05-27WarningsExact identifier
application number: M032
DermaZincPYRITHIONE ZINCWynnPharm Ince71e87ba-2a62-44f3-e053-2995a90a8b112025-05-25WarningsExact identifier
application number: M032
Tagrid ANTI FUNGALZINC PYRITHIONE,SALICYLIC ACIDTAGRID LLC3376b104-1f07-fab3-e063-6394a90a0ca42025-05-22WarningsExact identifier
application number: M032
Coal TarCOAL TARNopsor USA Distribution Co., Inc.407bd007-bec6-2864-e054-00144ff88e882025-05-05WarningsExact identifier
application number: M032
AntiDandruffShampoo365 ANTI DANDRUFF SHAMPOOWhole Foods Market, Inc.b9bc6bbb-31c5-427e-e053-2995a90a5f172025-04-29WarningsExact identifier
application number: M032
AntiDandruffShampooConditioner365 ANTI DANDRUFF SHAMPOO CONDITIONER 2 IN 1Whole Foods Market, Inc.c3f5b5fb-acb0-a904-e053-2995a90a56232025-04-29WarningsExact identifier
application number: M032
UTTSE Anti Fungal Shampoo.ANTI FUNGAL SHAMPOOShenzhen Xinxin Yunhai Technology Co., Ltd.33bebbe9-e0ab-2f7d-e063-6294a90add4e2025-04-27WarningsExact identifier
application number: M032
Psalmonica Hair Growth SerumMINOXIDILGuangzhou Haishi Biological Technology Co., Ltd.3380fe6d-e057-401a-e063-6394a90a787a2025-04-24WarningsExact identifier
application number: M032
13.5oz 2 In 1 Dandruff Hair Cleanse and Conditioner - Eucalyptus and MintPYRITHIONE ZINC SHAMPOOChina Ningbo Shangge Cosmetics Technology Corp.3344c97b-8767-3f87-e063-6394a90a4f5d2025-04-21WarningsExact identifier
application number: M032
13.5oz 2 In 1 Dandruff Hair Cleanse and Conditioner - Shea and Cocoa ButterPYRITHIONE ZINC SHAMPOOChina Ningbo Shangge Cosmetics Technology Corp.3346e2c5-af28-74ad-e063-6394a90abbab2025-04-21WarningsExact 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