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 2 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
apgwgzminoxidil2%MINOXIDILGuangdong Jiaoyu Biotechnology Co., Ltd5957c990-e274-6278-e063-6394a90af2b72026-08-18WarningsExact identifier
application number: M032
EVERYDAY CLEAN DANDRUFFPYRITHIONE ZINCUniversal Distribution Center LLC3983b688-28ae-462e-8686-6cf2f2c1cca42026-08-18WarningsExact identifier
application number: M032
Prosoria Psoriasis TreatmentSALICYLIC ACIDNuvothera, Inc.378311aa-95f7-4c69-bc00-e688468262bd2026-08-18WarningsExact identifier
application number: M032
RoyceDerm Seborrheic Dermatitis and Psoriasis Treatment creamSALICYLIC ACID 3%RoyceDerm LLC496e178b-e29b-071e-e063-6394a90aa0182026-08-13WarningsExact identifier
application number: M032
RoyceDerm Seborrheic Dermatitis and Psoriasis shampoo.SALICYLIC ACID 3%RoyceDerm LLC4995ce33-e231-8f86-e063-6394a90af4862026-08-13WarningsExact identifier
application number: M032
Rida Hair Research Institute RHRI Neoketramin Antifungal Yeast ReliefPYRITHIONE ZINCRida LLCd1e4dee7-5962-4ec1-ab99-9d547077b2f22026-08-05WarningsExact identifier
application number: M032
Rida Hair Research Institute RHRI Neoketramin Antifungal Yeast Relief TreatmentSALICYLIC ACIDRida LLC6226ce12-432f-402e-bda7-a5ca96f0b8382026-08-05WarningsExact identifier
application number: M032
JOHNSON FOAMMINOXIDILJOHNSON BIOPHARMACEUTICAL INC.1d44a75c-c940-680c-e063-6394a90a58392026-08-02WarningsExact identifier
application number: M032
EVERYDAY CLEAN DANDRUFFPYRITHIONE ZINCNINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.5a03d4bb-72e6-cc9f-e063-6394a90ae19f2026-08-01WarningsExact identifier
application number: M032
TEA TREE Oil DANDRUFFPYRITHIONE ZINCNINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.5a0505a6-77ca-c56e-e063-6394a90aea6f2026-08-01WarningsExact identifier
application number: M032
ITCHY SCALP RELIEF DANDRUFFPYRITHIONE ZINCNINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.5a0521cd-2b9e-e02c-e063-6394a90a5f022026-08-01WarningsExact identifier
application number: M032
SMOOTH AND SOFT DANDRUFFPYRITHIONE ZINCNINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.5a054179-b0d7-3a0f-e063-6294a90a62092026-08-01WarningsExact identifier
application number: M032
FOLKI COSMETIC Psoriasis CreamSALICYLIC ACID 3% PSORIASIS CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.575786e0-21b8-ad9d-e063-6394a90ad0d42026-07-24WarningsExact identifier
application number: M032
RoyceDerm Psoriasis Scalp .spray.SALICYLIC ACID 2%RoyceDerm LLC57425b1a-4cf3-b133-e063-6394a90a84f52026-07-23WarningsExact identifier
application number: M032
RoyceDerm Psoriasis Scalp .Shampoo.SALICYLIC ACID 3%RoyceDerm LLC5743f813-57f7-f544-e063-6294a90ad3b82026-07-23WarningsExact identifier
application number: M032
Yodo SalilOINTMENTLaboratorio Neo Farmaco del Ecuador Neofarmaco Cia. LTDA.56812625-7eab-6a25-e063-6294a90a23fe2026-07-20WarningsExact identifier
application number: M032
Pureskin Seborrheic Dermatitis and Psoriasis CreamSEBORRHEIC DERMATITIS PSORIASIS CREAMBENLONG HALL LLC36086f7f-8536-417f-a302-37f78288489e2026-07-20WarningsExact identifier
application number: M032
5%MINOXIDIL TOPICAL FOAMMINOXIDILVeloce Trading Co., Limited56f87881-653f-17e6-e063-6294a90a67872026-07-19WarningsExact identifier
application number: M032
ProBliva Psoriasis Shampoo.SALICYLIC ACID 3%CAVTECH HOLDING LLC563e75f9-a1e2-2796-e063-6294a90aedb42026-07-10WarningsExact identifier
application number: M032
ProBliva Anti Dandruff Shampoo.SELENIUM SULFIDE 1%CAVTECH HOLDING LLC56022f6b-d7ba-1ccd-e063-6294a90a73102026-07-07WarningsExact 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